Endpoints

Clinical Versus Biological Endpoints

Clinical Trials

Different Clinical Trial Designs

Clinical Trials: Overview

Clinical Trials: Overview

Conclusion

The Need for Clinical Trials

Clinical Trials in Drug Development

The Purpose of Clinical Trials

Clinical Trials in Drug Development

The Purpose of Clinical Trials: Phases

Clinical Trials: Post Completion

Publications Requirements for Clinical Trials

Dabigatran Clinical Trials: Summary

Dabigatran Clinical Trials: Summary

Rivaroxaban Clinical Trials: Summary

Rivaroxaban Clinical Trials: Summary

Apixaban Clinical Trials: Summary

Apixaban Clinical Trials: Summary

Drug Development Overview

Clinical Trial

Clinical Trials in Drug Development

The Purpose of Clinical Trials
The Purpose of Clinical Trials: Phases

Clinical Trials

Clinical Trials for Conventional Antipsychotics

Endpoints

Endpoints
Primary and Secondary Endpoints
Objective and Subjective Endpoints
Clinical...

Study Objectives

Understanding Clinical Design
Secondary Objectives
Studies are Carefully Planned
Clin...

Hypotheses

Trial Design

Diabetes Clinical Trial Design: Randomized Controlled Trial (RCT) Designs

Randomized Controlled Trial (RCT)

Study Objectives

Study Objectives: Protocol and Statistical Analysis Plan

Study Objectives

Secondary Objectives

Clinical Trials: Good Clinical Practice

Good Clinical Study Design

Summary

Interpreting Study Results and Properly Designed Clinical Trials

Review of Clinical Trials and Meta-analyses of Biologic Agents

Comparisons of Clinical Trial Results

Study Objectives

Understanding Clinical Design

Study Objectives

Clinical Plan

Introduction

The Use of Statistics in Clinical Trials and Scientific Hypothesis Testing

The Role of Interim Analysis

Trial Continuation

Drug Discovery

Clinical Trials

Drug Development Overview

Clinical Trial
Drug Development

Endpoints

Endpoints

Conclusion

The Need for Clinical Trials
A Well Designed Clinical Trial Can Have Pronounced Effects on Clin...

Conclusion

A Well Designed Clinical Trial Can Have Pronounced Effects on Clinical Practice

Clinical Trials: Outcomes in Diabetes Trials

Clinical Trial Outcomes

How to Interpret Study Results?

Clinical Relevance

Application of Design

Human Pharmacology (Typically in Phase I)
Human Pharmacology (Phase I)
Exploratory (Phase ...

SLE Treatments: MAbs/Biologics

Belimumab: Clinical Trials
Belimumab: Clinical Trial 1(Phase II)
Belimumab Clinical Trials...

Clinical Trials: Overview

Clinical Trial Design: Study Phases

Clinical Trials: Minimizing Bias

Minimizing Bias, Control or Comparator Groups, Blinding

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Warnings and Precautions

Summary

Hypotheses, Errors and Multiplicity
Interim Analysis
Intent-To-Treat, Per-Protocol Analysi...

Hypotheses

Statistical Hypothesis

Summary

Interim Analysis

Conclusion

The Need for Clinical Trials

Hypotheses

Alternative Hypothesis

Hypotheses

Proof by Contradiction

Types of Studies

Study Population

The Role of Interim Analysis

Interim Analysis
Interactive Exercise: Adjustment Methods
Trial Continuation

Application of Design

Human Pharmacology (Typically in Phase I)

Minimizing Bias

Blinding

Why is it Important to Control Type I Error?

Types of Multiplicity

Minimizing Bias

Minimizing Bias

Minimizing Bias

Multiple-Control Groups

Study Objectives

Classification Systems

Hypotheses

Statistical Tests

Hypotheses

Null Hypothesis

Hypotheses

P-Values

Endpoints

Primary and Secondary Endpoints

Introduction to Diabetes Clinical Trial Design

Conducting and Analyzing Clinical Trials

Minimizing Bias

Randomization

Study Objectives

Studies are Carefully Planned

Hypotheses

Significance Tests

Foundational Clinical Trials

Overview: Clinical Trials in Different Patient Populations

Clinical Trials of Biologic Agents

Introduction: Clinical Trials of Biologic Agents

Summary

Hypotheses, Errors and Multiplicity

Study Objectives

Study Objectives: Safety, Efficacy, Effectiveness, Comparison, and Outcomes

Endpoints

Objective and Subjective Endpoints

Minimizing Bias

Control Groups

Types of Studies

Design Types

Background of Clinical Trials

Clinical Trials of Biologic RA Treatments

Clinical Trials: Statistical Analysis

Analyzing the Results of Diabetes Trials

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Efficacy
Belimumab Clinical Trials 2 and 3: Warnings and Pre...

Dabigatran Clinical Trials: Atrial Fibrillation

Dabigatran Clinical Trials

Apixaban Clinical Trials: Atrial Fibrillation

Apixaban Clinical Trials

Rivaroxaban Clinical Trials: Atrial Fibrillation

Rivaroxaban Clinical Trials: Overview

Minimizing Bias

Minimizing Bias
Measures to Avoid Bias and Variability
Control Groups
Blinding
R...

Background

Clinical Trials

Foundational Clinical Trials

Metastatic Melanoma

Hypotheses

Statistical Hypothesis
Interactive Exercise: Phase 2 AMG 706 Trial
Statistical Tests
...

Prasugrel Clinical Trials

Objectives: Testing the Hypothesis

Foundational Clinical Trials

Combination Chemotherapy Trials in Metastatic Melanoma: Stage IV Melanoma

Dabigatran Clinical Trials: Venous Thromboembolism

REMEDY and RESONATE Trials

Development of Monoclonal Antibodies

Clinical Trial Goals

Prasugrel Clinical Trials

Recurrent Events Data

Background of Clinical Trials

Initial studies with Monoclonal Antibodies

Dabigatran Clinical Trials: Acute Coronary Syndrome

REDEEM Trial

Prasugrel Clinical Trials

MI Analysis (Including Universal Definition)

Rivaroxaban Clinical Trials: Venous Thromboembolism

EINSTEIN-PE Trial

What is the Intent to Treat Principle?

Incomplete Data

What is the Intent to Treat Principle?

Protocol Violations

What is the Intent to Treat Principle?

Excluding Events

How to Interpret Study Results?

Hypothesis Testing

Dabigatran Clinical Trials: Venous Thromboembolism

RECOVER Trial

Apixaban Clinical Trials: Atrial Fibrillation

ARISTOTLE Trial

Prasugrel Clinical Trials

JUMBO-TIMI 26 Study

Types of Studies

Experimental Studies: Design Examples

Research Study Design

Clinical Trials

Types of Studies

Design Types
Observational Studies: Cohort
Case-Control Study
Experimental Studies: D...

What is the Intent to Treat Principle?

Safety Analysis

The Role of Interim Analysis

Interim Analysis

Clinical Trials: Good Clinical Practice

Good Clinical Practice (GCP)

Drug Development Overview

Drug Development

Study Objectives

Elements of a Well-Written Study Objective

Types of Studies

Case-Control Study

Types of Studies

Reducing Assessment Variability

Application of Design

Human Pharmacology (Phase I)

Application of Design

Exploratory (Phase II)

Application of Design

Therapeutic Use (Phase IV)

What is the Intent to Treat Principle?

Imputation

SLE Treatments: MAbs/Biologics

Belimumab
Belimumab: Indication
Belimumab: Mechanism of Action
Belimumab: Dosage and ...

Why is it Important to Control Type I Error?

Errors in Significance Testing
Type I Errors: Significance Level
Type II Errors: Power

Minimizing Bias

Measures to Avoid Bias and Variability

Types of Studies

Observational Studies: Cohort

What is the Intent to Treat Principle?

Incomplete Data
Protocol Violations
Intent-To-Treat (ITT) and Pro-Protocol (PP) Analyses

Diagnosis of RA

Clinical Measures - Measures used in Clinical Trials

Clinical Trials: Minimizing Bias

Minimizing Bias

How Are Sample Size Calculations Made?

Sample Size
Interactive Exercise: Sample Size
Sample Size Calculations

Review of Clinical Trials and Meta-analyses of Biologic Agents

Introduction: Review of Clinical Trials

Clinical Trials: Patient Disposition

Patient Disposition

Clinical Trials: Minimizing Bias

Randomization

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Trial Design

Clinical Trials: Study Populations

Types of Study Populations

Clinical Trials: Cardiovascular Outcomes for Diabetes Drugs

Common Outcomes in Diabetes Trials

Diabetes Clinical Trial Design: Cohort Designs

Cohort Study

Clinical Trials: Primary and Secondary Outcomes

Trial Design, Choosing a P Value

Clinical Trials: Event Definitions

Analyzing the Results of Diabetes Trials: Relative Risk

Bone Sarcoma

Foundational Clinical Trials: Chondrosarcoma

How to Interpret Study Results?

Hypothesis Testing
Interactive Exercise: Definitive and Non-definitive Results
Clinical Re...

Bone Sarcoma

Foundational Clinical Trials: Incorporating Ifosfamide

Bone Sarcoma

Foundational Clinical Trials: Ewing Sarcoma

Investigational Treatment Strategies

Investigational Clinical Trials: Immunotherapy

Study Design: Active-Controlled Trials

Active-Controlled Trials

SLE Treatments: MAbs/Biologics

Belimumab: Clinical Trials

Foundational Clinical Trials

Metastatic Melanoma:Darthmouth Regimen

Prasugrel Clinical Trials

Early and Late Events (Landmark Analysis): Study Design

Dabigatran Clinical Trials: Atrial Fibrillation

RELY Study

Rivaroxaban Clinical Trials: Atrial Fibrillation

ROCKET Atrial Fibrillation

Soft Tissue Sarcomas (STSs)

Foundational Clinical Trials: Interpretation of Clinical Data

Conclusion

FDA Approves New HRT Warning Label

Minimizing Bias

Accidental Bias: Randomization Fails to Balance Risk Factors

Diagnosis of RA

Measures Used in Clinical Trials - EULAR

Why is it Important to Control Type I Error?

Multiple Primary Endpoints

Why is it Important to Control Type I Error?

Type II Errors: Power

How Are Sample Size Calculations Made?

Sample Size

Summary

Intent-To-Treat, Per-Protocol Analysis and Sample Size

Why is it Important to Control Type I Error?

Errors in Significance Testing

Diagnosis of RA

Measures Used in Clinical Trials - ACR

Diagnosis of RA

Measures Used in Clinical Trials - DAS

Application of Design

Pivotal/Confirmatory (Typically Phase 2/3)

How Are Sample Size Calculations Made?

Sample Size Calculations

Bone Sarcoma

Foundational Clinical Trials: Osteosarcoma - Aggressive Preoperative Chemotherapy

Diabetes Clinical Trial Design: Overview

Different Types of Study Design for Different Purposes

How to Interpret Study Results?

Hypothesis Testing
Interactive Exercise: Definitive and Non-definitive Results

Why is it Important to Control Type I Error?

Type I Errors: Significance Level
Type II Errors: Power

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Trial Design
Belimumab Clinical Trials 2 and 3: Study Endpo...

Aspirin and Primary Stroke Prevention

Clinical Trials and Meta-analysis Data

Clinical Trials: Primary and Secondary Outcomes

Example of a Primary Outcome: Liraglutide vs. Sitagliptin

Investigational Treatment Strategies

Investigational Clinical Trials: Vaccines and New Targeted Therapies

Diabetes Clinical Trial Design: Case Control Designs

Case Control Study

Diabetes Clinical Trial Design: Cross-Sectional Survey Designs

Cross-Sectional Survey

Diabetes Clinical Trial Design: Crossover Designs

Randomized Crossover Design

Foundational Clinical Trials

Metastatic Melanoma: BCT Pooled Analyses

Investigational Treatment Strategies

Investigational Clinical Trials: Targeting Angiogenesis

Investigational Treatment Strategies

Investigational Clinical Trials: Toll-Like Receptor Agonists

Investigational Treatment Strategies

Investigational Clinical Trials: Adoptive Cell Therapy

Additional Treatment Options

Targeted Therapies in Clinical Trials

SLE Treatments: MAbs/Biologics

Belimumab: Clinical Trial 1(Phase II)

Review of Clinical Trials and Meta-analyses of Biologic Agents

Biologic Treatments and Remission in Early RA

Rivaroxaban Clinical Trials: Overview of Other Development Programs

Development Programs: Rivaroxaban

Research Study Design

Clinical Trials
Research Study Design

Bone Sarcoma

Foundational Clinical Trials: Osteosarcoma - Survival Rates

Why is it Important to Control Type I Error?

Type I Errors: Significance Level

Investigational Treatment Strategies

Investigational Clinical Trials

What is the Intent to Treat Principle?

Intent-To-Treat (ITT) and Pro-Protocol (PP) Analyses

Diagnosis of RA

Measures Used in Clinical Trials - Assessment of Joint Damage by X-Ray

Soft Tissue Sarcomas (STSs)

Foundational Clinical Trials: Summary of Foundational Studies

Phase III Data: Hokusai-VTE

Phase III Clinical Trials

Soft Tissue Sarcomas (STSs)

Foundational Clinical Trials: Limb-Sparing Surgery

Additional Treatment Options

Targeted Therapies in Clinical Trials: Additional Targets

Treatment for Neuropsychiatric Symptoms in AD

Clinical Antipsychotic Trials of Intervention Effectiveness - Alzheimers Disease (CATIE-AD)

Introduction to Diabetes and Diabetes Terminology

Diagnosing and Treating Diabetes

Diabetes Clinical Trials Studying Complications

UK Prospective Diabetes Study (UKPDS)

Selected Basal Insulin Clinical Trials

Insulin Glargine vs. Insulin Detemir

Prasugrel Clinical Trials

TRITON-TIMI 38 Clinical Trial

Diabetes Clinical Trial Summary

The Diabetes mellitus Insulin-Glucose infusion in Acute Myocardial Infarction 2 study (DIGAMI 2)

Foundational Clinical Trials

Adjuvant Therapy Trials: IFN-a

Investigational Treatment Strategies

Investigational Clinical Trials: Therapeutic Cancer Vaccines

Foundational Clinical Trials

New Targeted Therapies: Molecular Therapies in HNSCC

Introduction to Diabetes and Diabetes Terminology

Introduction to Diabetes and Diabetes Terminology

Foundational Clinical Trials

Adjuvant Therapy Trials: ECOG

Clinical Applications of Monoclonal Antibodies

mAbs in Clinical Trials

Clopidogrel Clinical Trials

PCI Studies

Clopidogrel Clinical Trials

PCI-CURE Study

Clopidogrel Clinical Trials

ISAR CHOICE Study

Clopidogrel Clinical Trials

CAPRIE: Conclusion

Clopidogrel Clinical Trials

ALBION Study

Clopidogrel Clinical Trials

Registration Studies

Clopidogrel Clinical Trials

ARMYDA-2 Study

Clopidogrel Clinical Trials

COMMIT Study

Clopidogrel Clinical Trials

CURRENT-OASIS 7: Results

Clopidogrel Clinical Trials

CURE Study

Clopidogrel Clinical Trials

CLARITY Study

Clopidogrel Clinical Trials

CURRENT-OASIS 7 Study

Clopidogrel Clinical Trials

High Loading Dose Studies

Clopidogrel Clinical Trials

Pretreatment Study

Clopidogrel Clinical Trials

PCI-CLARITY Study

Clopidogrel Clinical Trials

CREDO Study

Clopidogrel Clinical Trials

CAPRIE

Clopidogrel Clinical Trials

ARMYDA-2: Conclusion

Foundational Clinical Trials

Metastatic Melanoma

Clopidogrel Clinical Trials

CREDO: Conclusion

Clopidogrel Clinical Trials

Non-ACS (including Stroke) Studies

Clopidogrel Clinical Trials

CARESS Study

Clopidogrel Clinical Trials

CARESS: Results

Clopidogrel Clinical Trials

MATCH Study

Clopidogrel Clinical Trials

MATCH: Conclusion

Clopidogrel Clinical Trials

CHARISMA Study

Clopidogrel Clinical Trials

CHARISMA: Asymptomatic and Symptomatic

Prasugrel Clinical Trials

JUMBO TIMI 26: Results

Prasugrel Clinical Trials

Objectives: Primary Endpoints

Prasugrel Clinical Trials

Primary Efficacy and Safety Data

Prasugrel Clinical Trials

Stent Thrombosis Sub-Analysis

Prasugrel Clinical Trials

Stent Thrombosis Sub-Analysis: Results and Conclusion

Prasugrel Clinical Trials

Early and Late Events (Landmark Analysis)

Prasugrel Clinical Trials

Recurrent Events Data: Results and Conclusion

Prasugrel Clinical Trials

STEMI Population Data

Prasugrel Clinical Trials

STEMI Population Data: Conclusion

Prasugrel Clinical Trials

MI Analysis (Including Universal Definition): Results

Prasugrel Clinical Trials

MI Analysis (Including Universal Definition)

Prasugrel Clinical Trials

Diabetes Data

Prasugrel Clinical Trials

Diabetes Data: Conclusion

Prasugrel Clinical Trials

PRINCIPLE-TIMI 44 Study

Prasugrel Clinical Trials

PRINCIPLE-TIMI 44: Results and Conclusion

Dabigatran Clinical Trials: Atrial Fibrillation

RELY-ABLE Trial

Apixaban Clinical Trials: Acute Coronary Syndrome

APPRAISE2 Trial

Prasugrel Clinical Trials

Primary Efficacy and Safety Data: Net Clinical Benefit and Conclusion

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Trial Design

Foundational Clinical Trials

Combination Chemotherapy Trials in Metastatic Melanoma

Foundational Clinical Trials

Metastatic Melanoma: CVD Regimen

Foundational Clinical Trials

Metastatic Melanoma: Combination Regimens

Foundational Clinical Trials

Metastatic Melanoma: Biologics

Foundational Clinical Trials

Metastatic Melanoma: IL-2

Dabigatran Clinical Trials: Atrial Fibrillation

RELY: Study Population Results

Dabigatran Clinical Trials: Atrial Fibrillation

RELY Results: Other Outcomes

Dabigatran Clinical Trials: Atrial Fibrillation

RELY-ABLE

Dabigatran Clinical Trials: Venous Thromboembolism

RECOVER: Study Population Results

Dabigatran Clinical Trials: Venous Thromboembolism

RECOVER: Results Summary

Rivaroxaban Clinical Trials: Atrial Fibrillation

XANTUS Study

Rivaroxaban Clinical Trials: Venous Thromboembolism

EINSTEIN-DVT Study

Rivaroxaban Clinical Trials: Venous Thromboembolism

EINSTEIN-DVT: Safety Results

Rivaroxaban Clinical Trials: Venous Thromboembolism

EINSTEIN-PE: Safety Results

Rivaroxaban Clinical Trials: Venous Thromboembolism

EINSTEIN-EXT Study

Rivaroxaban Clinical Trials: Venous Thromboembolism

XALIA Study

Apixaban Clinical Trials: Atrial Fibrillation

AVERROES Study

Apixaban Clinical Trials: Atrial Fibrillation

ARISTOTLE: Baseline Characteristics Results

Apixaban Clinical Trials: Atrial Fibrillation

ARISTOTLE: Efficacy Results

Apixaban Clinical Trials: Atrial Fibrillation

ARISTOTLE: Safety Results

Apixaban Clinical Trials: Atrial Fibrillation

ARISTOTLE: Results Summary

Apixaban Clinical Trials: Venous Thromboembolism

AMPLIFY Study

Apixaban Clinical Trials: Venous Thromboembolism

AMPLIFY Study: Safety Results

Apixaban Clinical Trials: Venous Thromboembolism

AMPLIFY Study: Results Summary

Apixaban Clinical Trials: Venous Thromboembolism

AMPLIFY-EXT Study

Dabigatran Clinical Trials: Acute Coronary Syndrome

REDEEM Trial: D-dimer Concentrations

Rivaroxaban Clinical Trials: Acute Coronary Syndrome

ATLAS-ACS2 Trial

Drug Discovery

Drug Discovery
Target vs. Platform-driven Discovery
Target Validation
Targeting Strat...

Diagnosis of SLE

Standard Measures of Disease Activity Used in Clinical Trials: SLAM

Diagnosis of SLE

Standard Measures of Disease Activity Used in Clinical Trials: ECLAM

Diagnosis of SLE

Standard Measures of Disease Activity Used in Clinical Trials

Diagnosis of SLE

Standard Measures of Disease Activity Used in Clinical Trials: SLEDAI

Diagnosis of SLE

Standard Measures of Disease Activity Used in Clinical Trials: SELENA-SLEDAI

Diagnosis of SLE

Standard Measures of Disease Activity Used in Clinical Trials: SLEDAI-2K

Rivaroxaban Clinical Trials: Venous Thromboembolism

EINSTEIN-DVT: Net Clinical Benefit and Summary

Rivaroxaban Clinical Trials: Venous Thromboembolism

EINSTEIN-PE: Net Clinical Benefit and Summary

Selected Basal Insulin Clinical Trials

NPH Insulin vs. Glargine Comparator Trials

Diagnosis of SLE

Standard Measures of Disease Activity Used in Clinical Trials: SLAM
Standard Measures of Diseas...

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Efficacy

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Efficacy

Diabetes Clinical Trials Studying Complications

DCCT/EDIC Study

Diabetes Clinical Trials Studying Complications

DCCT/EDIC Study

Foundational Clinical Trials

Primary Melanoma IFN-α Adjuvant Therapy

Foundational Clinical Trials

Metastatic Melanoma: Single-Agent Chemotherapy

Foundational Clinical Trials

Metastatic Melanoma: PC Combination Regimen

Foundational Clinical Trials

Metastatic Melanoma: Biochemotherapy and Sequential vs. Concurrent BCT

Foundational Clinical Trials

Metastatic Melanoma: Biochemotherapy (BCT)

Dabigatran Clinical Trials: Atrial Fibrillation

RELY Results: Primary Outcome Stroke or Systemic Embolism

Dabigatran Clinical Trials: Atrial Fibrillation

RELY Results: Secondary Outcome Stroke

Dabigatran Clinical Trials: Atrial Fibrillation

RELY Results: Primary Safety Outcome Major-Bleeding, Dabigatran vs. Warfarin

Dabigatran Clinical Trials: Venous Thromboembolism

RECOVER: Primary and Secondary Efficacy Results

Dabigatran Clinical Trials: Acute Coronary Syndrome

Development Programs: RE-ALIGN Heart Valves

Rivaroxaban Clinical Trials: Atrial Fibrillation

ROCKET Atrial Fibrillation: Baseline Characteristics Results

Rivaroxaban Clinical Trials: Atrial Fibrillation

ROCKET Atrial Fibrillation: Primary Efficacy Results

Rivaroxaban Clinical Trials: Atrial Fibrillation

ROCKET Atrial Fibrillation: Primary Efficacy Events During Transition to Open-Label Therapy

Rivaroxaban Clinical Trials: Atrial Fibrillation

ROCKET Atrial Fibrillation: Secondary Efficacy Outcomes

Rivaroxaban Clinical Trials: Atrial Fibrillation

ROCKET Atrial Fibrillation: Results Summary

Rivaroxaban Clinical Trials: Venous Thromboembolism

EINSTEIN-DVT: Baseline Characteristic Results

Rivaroxaban Clinical Trials: Venous Thromboembolism

EINSTEIN-DVT: Primary Efficacy Results

Rivaroxaban Clinical Trials: Venous Thromboembolism

EINSTEIN-DVT: Primary Efficacy Results Time Course

Rivaroxaban Clinical Trials: Venous Thromboembolism

EINSTEIN-PE: Baseline Characteristics Results

Rivaroxaban Clinical Trials: Venous Thromboembolism

EINSTEIN-PE: Primary Efficacy Results

Rivaroxaban Clinical Trials: Venous Thromboembolism

EINSTEIN-PE: Primary Efficacy Results Time Course

Rivaroxaban Clinical Trials: Acute Coronary Syndrome

X-PLORER Study

Apixaban Clinical Trials: Venous Thromboembolism

AMPLIFY Study: Baseline Characteristics Results and Primary Efficacy Results

Apixaban Clinical Trials: Overview of Other Development Programs

Development Programs: Overview

Review of Clinical Trials and Meta-analyses of Biologic Agents

Efficacy of Biologic Agent Monotherapy in MTX-Naive Patients

Review of Clinical Trials and Meta-analyses of Biologic Agents

Sequential Use of TNFα inhibitors

Review of Clinical Trials and Meta-analyses of Biologic Agents

Sequential Use of TNFα inhibitors: Comparing Studies

Selected Basal Insulin Clinical Trials

Glargine vs. Standard of Care

Selected Basal Insulin Clinical Trials

Complex insulin regimens

Selected Basal Insulin Clinical Trials

DEVOTE

Phase III Clinical Studies

Overview of AWARD Trials 1-6

Diagnosis of SLE

Standard Measures of Disease Activity Used in Clinical Trials: SLEDAI-2K
Standard Measures of D...

Diagnosis of SLE

Standard Measures of Disease Activity Used in Clinical Trials: SLICC/ACR Damage Index for SLE

Diagnosis of SLE

Standard Measures of Disease Activity Used in Clinical Trials: SLE Responder Index (SRI-4)

Diagnosis of SLE

Standard Measures of Disease Activity Used in Clinical Trials: BILAG, SLAM, ECLAM

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Study Endpoints

Investigational Treatment Strategies

c-Kit and HER-2, Carcinoembryonic Antigen (CEA) and Targeted Therapy Clinical Trials for HNSCC

Review of Clinical Trials and Meta-analyses of Biologic Agents

Efficacy of Biologic Treatment and MTX Combination Therapy in MTX-Naive Patients

Review of Clinical Trials and Meta-analyses of Biologic Agents

Efficacy of Biologic Treatment and MTX Combination Therapy in MTX-Experienced Patients

Review of Clinical Trials and Meta-analyses of Biologic Agents

Efficacy of Combined Biologic Treatment and DMARD Therapy in DMARD-Experienced Patients

Selected Basal Insulin Clinical Trials

Insulin Degludec BEGIN Meta-Analysis

Clinical Trials Comparing GLP-1 Receptor Agonists

Comparative Efficacy of GLP-1 Receptor Agonists

Clinical Trials Comparing GLP-1 Receptor Agonists

Comparison of GLP-1 Receptor Agonists

Introduction

FDA Approval for Biologics

Introduction

FDA Approval for Biologics

Foundational Clinical Trials

Radiotherapy Studies

Foundational Clinical Trials

Postoperative Radiotherapy and Chemoradiotherapy

Foundational Clinical Trials

Concurrent Chemoradiation Regimens: Incidence of Acute Adverse Events

Foundational Clinical Trials

Induction Chemotherapy: VA Cooperative and RTOG 91-11 Studies

Foundational Clinical Trials

New Targeted Therapies: Targeted Therapies as Single Therapies

Foundational Clinical Trials

Salivary Gland Cancer

Soft Tissue Sarcomas (STSs)

Foundational Clinical Trials: Surgery and Radiotherapy

Soft Tissue Sarcomas (STSs)

Foundational Clinical Trials: Adjuvant Radiotherapy

Soft Tissue Sarcomas (STSs)

Foundational Clinical Trials: Adjuvant Chemotherapy (SMAC)

Soft Tissue Sarcomas (STSs)

Foundational Clinical Trials: Adjuvant Chemotherapy - Survival

Soft Tissue Sarcomas (STSs)

Foundational Clinical Trials: Adjuvant Chemotherapy - GIST

Soft Tissue Sarcomas (STSs)

Foundational Clinical Trials: Resistance to Imatinib

Soft Tissue Sarcomas (STSs)

Foundational Clinical Trials: Neoadjuvant Chemotherapy

Development of Monoclonal Antibodies

Monoclonal Antibody Production in Hybridomas
Monoclonal Antibody Production in CHO Cells
M...

Foundational Clinical Trials

Concurrent Chemoradiation Regimens: Standard of Care

Foundational Clinical Trials

Induction Chemotherapy: TAX 232 and TAX 324 Studies

Foundational Clinical Trials

Recurrent Unresectable/Metastatic HNSCC

Drug Development

Biomarkers May Bridge the Gap between Animal Studies and Large Clinical Trials

Introduction

The Critical Path for Medical Product Development
The Immune System Modulators
Interactive...

Introduction

FDA Approval for Biologics
How Does a Drug Get Approved?

Introduction

FDA Approval for Biologics
How Does a Drug Get Approved?

Clinical Applications of Monoclonal Antibodies

Clinical Applications of Monoclonal Antibodies: Learning Objectives
Detection, Diagnosis, and M...

Introduction

Introduction to Clinical Statistics

Distribution Functions

Binomial Distribution

Combination Product Regulation

Combination Products: One or Two Reviewers?

Abatacept: Clinical Studies

Abatacept: Clinical Studies

Summary: Clinical Statistics

How to Choose a Statistical Test

Cholinesterase Inhibitors: Rivastigmine

Clinical Studies: Overview

Fibrates

Side Effects, Efficacy, and Safety: Fibrates

Acetylcholinesterase Inhibitors: Donepezil

Acetylcholinesterase Inhibitors - Donepezil

Ustekinumab

Pivotal Trials: Overview
Pivotal Trials: Trial Design
Pivotal Trials: Endpoints
Pivot...

Golimumab: Clinical Studies

Golimumab: Clinical Studies

Adalimumab: Clinical Studies

Adalimumab: Clinical Studies

Current Therapies

Disease Modifying Therapy (DMT): Rationale for Early Treatment

Currently Approved Therapies: Novantrone

Aubagio

Bleeding in ACS: Clinical Definition of Bleeding

Need for Standardization of Bleeding Definition

Phase III Clinical Studies

Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

Currently Approved Therapies: Interferon Beta

Rebif

Currently Approved Therapies: Interferon Beta

Betaseron/Extavia

Statins

Efficacy and Safety: Therapy Results

Statistical Tests

Significance Level

Soft Tissue Sarcomas (STSs)

Investigational Treatment Strategies: Soft Tissue Sarcoma Investigational Trials

Bone Sarcoma

Investigational Treatment Strategies: Selected Investigational Trials

Phase 3 Clinical Studies

Dulaglutide: REWIND

Considerations for Developing a Protein Formulation

Development Timeline

The Future

Future Applications for Biologics

Distribution Functions

Gaussian (Normal) and Skew Distributions
Exponential Distributions
Binomial Distribution

PCSK9 Inhibitors

Side Effects

Drug Addiction Treatment Act of 2000

Criteria and Physician Qualification

Bleeding in ACS: Clinical Definition of Bleeding

Challenges

GLP-1 Receptor Agonists and Cardiovascular Events

GLP-1 Receptor Agonists: Effect of on Cardiovascular Events

Glycemic Control Intervention in Type 2 Diabetes: Heart2D

Hyperglycemia and its Effect after Acute myocardial infaRction on cardiovascular outcomes in patient...

Glycemic Control Intervention in Type 2 Diabetes: Treat-to-Target

Treat-to-Target Trial: Glargine and Human NPH

Bleeding in ACS: Clinical Definition of Bleeding

Incidence of Bleeding

Infliximab

Infliximab Safety

Infliximab

Pivotal Trials: Efficacy of Maintenance
Infliximab Safety

Infliximab: Clinical Studies

Infliximab: Clinical Studies

Development of Monoclonal Antibodies

Preclinical Testing of Therapeutic Antibodies

Investigational Therapies

Momelotinib (MMB; CYT387): JAK Inhibitor

Marketplace

Getting into the Market: The Approval Process

Treatment Strategies

Disease-Modifying Therapies

Advancing Technologies

Advanced Imaging Techniques: Magnetic Resonance Spectroscopy (MRS)

Platelet Receptor Physiology

IIb/IIIa as a Target

Current Treatment

Advanced Stage IV Melanoma: Second-Line Therapy

Investigational Treatment Strategies

Targeting the Molecular Pathways Controlling Tumor Cell Proliferation

Investigational Treatment Strategies

Pro-Apoptotic Agents & Chemosensitization to Overcome Drug Resistance: Chemosensitization

Investigational Treatment Strategies

Pro-Apoptotic Agents & Chemosensitization to Overcome Drug Resistance: Pro-apoptotic Agents Under In...

Passive Immunization

Bapineuzumab Phase II: Cognitive Measures

Glycemic Control Intervention in Type 2 Diabetes: DURABLE

The DURAbility of Basal Versus Lispro mix 75/25 Insulin Efficacy Trial (DURABLE)

Glycemic Control Intervention in Type 2 Diabetes: 4-T

Treating To Target in Type 2 Diabetes (4-T)

Glycemic Control Intervention in Type 2 Diabetes: INITIATE

INITIATing Insulin Therapy in Type 2 DiabEtes (INITIATE)

Glycemic Control Intervention in Type 2 Diabetes: LANMET

Insulin gLArgine or NPH combined with METformin in type 2 diabetes (LANMET)

Glycemic Control Intervention in Type 2 Diabetes: ORIGIN

The Outcome Reduction with Initial Glargine INtervention trial (ORIGIN)

Glycemic Control Intervention in Type 2 Diabetes: Treat-to-Target Trial with Insulin Detemir versus Insulin Glargine

Treat-to-Target Trial: Insulin Detemir versus Glargine

Non-biologic DMARDs: Methotrexate

Pivotal Clinical Studies: Methotrexate

Diagnosis of RA

Overview - Diagnosis of RA

Research Study Design

Research Study Design

Anatomy and Pathophysiology

Clinical Examination: Ocular Melanoma

Regulation of Biological Products and Drugs

Biological Product Regulation

Treatment for Neuropsychiatric Symptoms in AD

Treatment of Depression

Currently Approved Therapies: Interferon Beta

Avonex

Summary: Clinical Statistics

Types of Data
How to Choose a Statistical Test

Regulation of Biosimilars

Evidence Generation: Clinical

Cost-Effectiveness Studies: Mahmoudi and Sobieraj, 2013

Methods: Studies Included in the Analysis and Quality-of-Life Measures

Treatment for Neuropsychiatric Symptoms in AD

Treatment of Psychosis and Agitation

Summary: Cancer-associated VTE

Summary: Cancer-associated VTE

Active Immunization

AN1792 Phase I Safety Trial

Non-biologic DMARDs: Methotrexate

Pivotal Clinical Studies

Economic Burden of Stroke

Stroke Risk Based Upon Anticoagulation Use

Introduction

Biomarkers and Development of Clinical Therapeutics: ADNI

Medical Device Regulation

Regulatory Classifications: Investigational Device Exemption (IDE)

Acetylcholinesterase Inhibitors: Galantamine

Dosage and Administration - Galantamine

Cholinesterase Inhibitors: Galantamine

Clinical Studies - Overview

Drug Development

Biomarkers to Monitor and Track Biochemical Drug Effects

Diagnostic Criteria

Different Classification Criteria

Diagnosis of RA

2010 Rheumatoid Arthritis Classification

Emerging Hypotheses on Treatment

Genetic Concepts: Chances for Success

Therapeutic Regimens Recommended Antiretroviral Regimens

Recommended Antiretroviral Regimens

Monoclonal Antibodies in Action

Conjugate Delivery: Antibody-Directed Enzyme Prodrug Therapy (ADEPT)

Development of Monoclonal Antibodies

Preclinical Safety Testing

Ustekinumab

Pivotal Trials: Overview

Current Treatment

NCCN Guidelines - Stage III and IV

Current Treatment

Post-Surgical Adjuvant Therapy

Bone Sarcoma

Investigational Treatment Strategies: Bone Sarcoma

Active Immunization

V950: Active Anti-Aβ Vaccine

Genetic Markers

Genetic Advances and Technologies: Advances Since the Human Genome Project

Clopidogrel

Drug Interactions and Hyporesponse

Anakinra: Clinical Studies

Anakinra: Clinical Studies

Stent Thrombosis

Definitions: Protocol Definitions and Potential Bias

Government Regulation and Approval Pathways

Drug Patents and Generics

Cost-Effectiveness Studies: Harrington et al., 2013

Methods Endpoints

Currently Approved Therapies: Tecfidera

Tecfidera

Biosimilarity

Demonstrating Biosimilarity

Currently Approved Therapies: Novantrone

Novantrone, Mitoxantrone

Signs and Symptoms

Damage to Specific CNS Regions

Summary

Summary: Existing and Emerging GLP-1 Therapies

Basaglar Insulin Glargine

Efficacy and Safety

Basaglar Insulin Glargine

ELEMENT Trials: Efficacy and Safety

Summary

Existing and Emerging GLP-1 Therapies

Standard Agents: Selected Clinical Studies

Vitamin K Antagonists (VKAs): Warfarin

Psoriasis Therapies

Retinoids: Clinical Efficacy

Background: Osteoporosis

Osteoporosis Background Information

Biomarkers for the Diagnosis of AD

MRI and Ventricular Expansion

Controversies in Androgen Replacement Therapy

Prostate - Testosterone Registry

Therapeutic Regimens Recommended Antiretroviral Regimens

Recommended Antiretroviral Regimens
HAART Regimens

Adalimumab

Pivotal Trials

Infliximab

Pivotal Trials: Overview

Etanercept

Pivotal Trials: Overview

PK Parameters

Determinants of Pharmacokinetics (PK) and Drug Exposure and Pharmacokinetics

Investigational Treatment Strategies

Targeting the Molecular Pathways Controlling Tumor Cell Proliferation: Importance of Combination Str...

Diagnosis and Management

Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)

Criteria for the Diagnosis of Dementia Due to Alzheimer's Disease

Mini-Mental State Examination (MMSE)

Acetylcholinesterase Inhibitors: Rivastigmine

Dosage and Administration - Rivastigmine Oral Dosage

NMDA Receptor Antagonist - Memantine

Indication, Dosage and Administration

PK Models

Utility of PK Modeling

Introduction

Biomarkers and Development of Clinical Therapeutics

Premix vs. Basal-Prandial

Novomix 50 (BMI>30) or 70 (BMI≤30) at Breakfast and Lunch + Novomix 30 at Dinner Vs. Basal Pr...

Currently Approved Therapies: Tysabri

Currently Approved Therapies: Tysabri

Non-Pharmacologic Treatments

Integrative Response Therapy (IRT)

First-line Treatment Options

Introduction: First Time Treatment Options

Treatment Effects

Estimating Treatment Effects
Binary Data
Interactive Exercise: Estimating Treatment Effect...

Statistical Tests

Statistical Tests
Significance Level
P-Values
Choosing a P-Value
Interactive Exe...

Biological Products/Biologics vs. Biosimilars

Demonstrating Biosimilarity

Summary: Osteoporosis Diagnosis

Summary: Osteoporosis Diagnosis

Biosimilars

Benefits, Risks, Marketing, and Claims

Phase II Data: Atrial Fibrillation Dosing

Weitz Phase 2 NVAF Study

Basaglar Insulin Glargine

Immunogenicity

Government Regulation and Approval Pathways

U.S. Food and Drug Administration: Regulatory Oversight

Additional Recommendations and Position Statements

National Lipid Association (NLA) Recommendations for Patient-Centered Management of Dyslipidemia

Biosimilarity

What is Biosimilarity?, Demonstrating Biosimilarity

Infliximab

Pivotal Trials: Overview
Psoriasis Trial I: Study Design
Psoriasis Trial II: Study Design

Etanercept

Pivotal Trials: Overview
Psoriasis Trial I: Study Design
Psoriasis Trial II: Study Design

The Future

Development of Generics: Overview
Future Applications for Biologics

γ-Secretase Inhibition

GSI-953 and GSI-953: Effects in Transgenic Mice and Aβ Levels

Testosterone Replacement Therapy: Buccal Testosterone System

Buccal Testosterone System: Clinical Studies

Testosterone Replacement Therapy: Buccal Testosterone System

Buccal Testosterone System

Medical Device Regulation

Regulatory Classifications

GLP-1 Receptor Agonists and Weight Loss

Efficacy of Liraglutide for Weight Loss Among Patients with Type 2 Diabetes

Non-Bioequivalent Insulins

BIOD-531 U-400

Emerging Therapies

Emerging Therapies Overview

Biosimilars

Benefits, Risks, and Patent Life

Current Therapies

Overview: Current Therapies for MS
Treatment of Acute Relapses: Severe Relapses: Therapeutic P...

Currently Approved Therapies: Novantrone

Pivotal Trials

Introduction

The Critical Path for Medical Product Development

Biomarkers to Predict the Rate of Cognitive Decline in AD

FDG-PET by Voxel-Based Approaches

Standard Agents: Clinical Studies

Vitamin K Antagonists (VKAs): Warfarin

Testosterone Replacement Therapy: Transdermal Testosterone Patch

Transdermal Testosterone Patch: Clinical Studies

Pharmacokinetics and Pharmacodynamics

The Pharmacokinetics of Once-Weekly Dulaglutide in Patients with Renal Impairment

Adalimumab

Pivotal Trials
Pivotal Trials: Psoriasis Trial I
Psoriasis Trial I: Endpoints
Psorias...

Currently Approved Therapies: Gilenya

Gilenya

Basaglar Insulin Glargine

Immunogenicity: Background

Population PK

Population PK Approach and PK Sampling and Constructing a Population PK Model

Major Adverse Cardiac Events (MACE)

Major Adverse Cardiac Events (MACE)

Phase II Data: Atrial Fibrillation Dosing

Salazar Population Pharmacokinetics

Emerging Hypotheses on Treatment

Emerging Hypotheses on Treatment: Myelination-Targeted Antibodies
Cell Therapy
Human Stem ...

Research Study Design

Types of Clinical Studies

Government Regulation and Approval Pathways

European Medicines Agency (EMA)

AACE 2012 Guidelines for Management of Dyslipidemia and Prevention of Atherosclerosis

Follow-Up and Monitoring

Annotate: Hokusai

Hokusai-VTE Trial

Pharmacological Agents

Ursodeoxycholic Acid (UDCA): Studies

NMDA Receptor Antagonist - Memantine

Memantine Clinical Studies: Overview

Passive Immunization

Intravenous Immunoglobulin (IVIg) Pilot Studies

Drug Development

Value of Biochemical Markers in Drug Development

Cost-Effectiveness Studies: Harrington et al., 2013

Study Overview: Harrington et al.

Overview of Diagnosis

Clinical Stroke Classification Schemes: TOAST and SSS-TOAST

Overview: Cancer VTE

VTE and Cancer

2013 ACC/AHA Guidelines on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults

Areas of Controversy

Metastatic Breast Cancer: Introduction

Metastatic Breast Cancer: Introduction

Standard Agents: Selected Clinical Studies

Fondaparinux: Treatment of Pulmonary Embolism

Pharmacological Treatments

First-line Therapies for PTSD

Basaglar Insulin Glargine

Immunogenicity

PCSK9 Inhibitors

Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)

Marketplace

Stroke
Diabetes Mellitus
Growth Defects
Anemia
Neutropenia
Hepatitis
R...

Pharmacological Treatments

Third-line Therapies for PTSD

Diabetes Annotations

Critical Appraisal

Psoriasis Therapies

Systemic Therapies: Retinoids
Retinoids: Mechanism of Action
Retinoids: Clinical Efficacy

Standard Agents: Overview

Unfractionated Heparin (UFH)

Introduction to Pharmacology, Pharmacodynamics and Pharmacokinetics

Pharmacokinetics (PK) Terminology and Drug Development

Risk Factors

Alcohol Dependence (Alcoholism)
Interactive Exercise: Who's at Risk?
Risk Factors Base...

Considerations for Developing a Protein Formulation

Considerations for Developing a Protein Formulation: Introduction
Delivery Device
Marketin...

Element-1 Trial

Element-2 Trial

What is the Role of Toxicology in Drug Development?

How Does Toxicology Relate to the Pre-Clinical Road Map?

Standard Agents: Overview

Unfractionated Heparin: Overview

Overview of Diagnosis

Stroke Scores Commonly Used

Traditional Treatments

JAK Inhibition: Ruxolitinib

Platelet Receptor Physiology

Substances That Cause Platelet Aggregation
Activation Pathways
ADP and Thromboxane A2

Phase II Data: Atrial Fibrillation Dosing

Chung Phase II Asian NVAF Study

Phase II Data: Monitoring of Edoxaban - Pharmacodynamics

Ogata Pharmacodynamics

Phase III Data: ENGAGE AF-TIMI 48

Methods: Patient Population, Study Design, and Endpoints

Cost-Effectiveness Studies: Mahmoudi and Sobieraj, 2013

Mahmoudi and Sobieraj Study: Study Overview

Standard Agents: Selected Clinical Studies

Fondaparinux: Treatment of Deep Vein Thrombosis

Management Guidelines

Interventions

Strategies of Abuse-Deterrent Opioids

Current Status and Challenges

BED Pathophysiology

Mu-Opioid Signaling Dysfunction

Current Treatment of Binge Eating Disorder (BED)

Treatment Goals and Guidelines

PK in Action

PK Prediction

Advancing Technologies

Biomarkers: Disease Process-Specific Biomarkers
Biomarkers: Inflammation Biomarkers
Biomar...

Overview of Diagnosis

Clinical Stroke Classification Schemes: Overview and Outcomes

Monoclonal Antibodies in Action

Effector Mechanisms - Overview
Neutralization of Circulating Factor
Antibody-Dependent Cel...

Risk Factors

Who's at Risk for Having Children with FASD?
Risk Factors Based on Study Population
In...

Phase I Data: Pharmacokinetic Parameters

Ogata Pharmacokinetics: Overview

Glucose Measures: Self-Monitoring

Glucose Meters, SMBG, Continuous Glucose Monitoring (CGM)

Treatment

Pharmacotherapy - Statins

Basaglar Insulin Glargine

ELEMENT 1: Efficacy and Safety

Statins

Side Effects

Annotate: ENGAGE

Edoxaban versus Warfarin in Patients with Atrial Fibrillation

Etiology of Hypertension

Risk Factors

PK/PD of Basaglar

Cancer Immunotherapy

Adoptive T Cell Transfer

What is the Role of Toxicology in Drug Development?

How Does Toxicology Relate to the Pre-Clinical Road Map?
Safety Pharmacology
In Vivo and I...

Methods and Instruments for Bone Densitometry

Vertebral Fracture Assessment (VFA): DXA Imaging of the Spine for Detection of Vertebral Fractures

Management of Colorectal Cancer

Targeted Therapies

VTE Clinical Picture: Risk Factors and Comorbid States

Risk Factors and Comorbid States

Diabetes Annotations

Abasaglar insulin glargine

Diabetes Annotations

Jardiance

Diagnosis and Treatment

Enzyme Replacement Therapy (ERT)

Basaglar Insulin Glargine

Efficacy and Safety: ELEMENT 2 Endpoints

Treatment

Pharmacotherapy - Cholesterol Absorption Inhibitor

Ticlopidine

Ticlopidine: Overview

Summary of Approved Therapies

Efficacy of Approved Multiple Sclerosis Therapies

VTE Clinical Picture: Risk Factors and Comorbid States

Risk Factors and Comorbid States

Etanercept

Safety

Diabetic Nephropathy

Treatment Components: Statins, Lovastatin and Ezetimibe

SLE Treatments: MAbs/Biologics

Abatacept: Side Effects

Standard Agents: Clinical Studies

Unfractionated Heparin (UFH) and Low-Molecular-Weight Heparins (LMWHs)

Investigational Therapies

Momelotinib (MMB, CYT387)

Current Therapies

Intensive Immune Suppression: Chemotherapeutic Agents

Country-Specific Definitions and Regulatory Guidelines

South Korea Ministry of Food and Drug Safety (MFDS)

Early Stages for Developing a Formulation

IND/Phase 1 Formulation

Prognosis

Clinical Scoring Systems: EDSS Limitations

Standard Agents: Selected Clinical Studies

Unfractionated Heparin (UFH) and Low Molecular Weight Heparins (LMWHs)

Phase III Clinical Studies

Summary of Safety and Tolerability Across the AWARD Program

Rituximab: Clinical Studies

Rituximab: Clinical Studies

Standard Agents: Overview

Fondaparinux: Overview

Biomarkers for the Prediction of MCI Conversion to AD

MRI

Diabetes Annotations

Humalog 200 units/ml KwikPen SmPC

Thienopyridines

Ticlopidine (TICLID)

Current Therapies

Intensive Immune Suppression: Cell Therapy

Cost-Effectiveness Studies: Kansal et al., 2013

Kansal Study: Results

Clinical Scoring Systems and Prognosis

EDSS Limitations

SLE Treatments: MAbs/Biologics

MAbs/Biologics: Abatacept
Abatacept: Efficacy
Abatacept: Side Effects

Treatment and Prevention of Cancer-associated VTE

Outpatients receiving chemotherapy: Agnelli et al, 2009

Biologics in Current Use - Abatacept

Warnings: Abatacept

Standard Agents: Therapeutic Challenges

Enoxaparin: Contraindications and Dalteparin: Warnings and Precautions

Treatment and Prevention of Cancer-associated VTE

Surgery Patients

Country-Specific Definitions and Regulatory Guidelines

India Ministry of Science and Technology (MST)

Country-Specific Definitions and Regulatory Guidelines

Health Canada

Country-Specific Definitions and Regulatory Guidelines

European Medicines Agency (EMA) Detailed Requirements

Standard Agents: Therapeutic Challenges

Fondaparinux: Warnings and Precautions

Emerging Therapies

Emerging Therapies

Emerging Hypotheses on Treatment

Genetic Concepts: Interleukin Receptors

Monoclonal Antibodies

Conjugated Monoclonal Antibodies

Non-Bioequivalent Insulins

Humulin R U-500: Safety and Efficacy

Management

Goals of Treatment

Biosimilars

Biosimilars Under Review

Country-Specific Definitions and Regulatory Guidelines

World Health Organization (WHO)

Emerging Hypotheses on Treatment

Immunological Concepts: Oral Immune-Modulating Drugs

Emerging Hypotheses on Treatment

Neurodegeneration: Direct Neuroprotection

Non-biologic DMARDs: Methotrexate

Clinical Studies: Multidrug Combinations

NCCN Guidelines

Risk Category and Current Treatment Strategies

Pharmacological Approaches

Pharmacological Approaches for MDS Treatment

Intensive Immune Suppression

Intensive Immune Suppression for Non-Responders

Treatment and Prevention of Cancer-associated VTE

VTE Therapeutic Agents

Country-Specific Definitions and Regulatory Guidelines

Food and Drug Administration (FDA) Detailed Requirements

Emerging Therapies for SLE

Emerging Therapies for SLE

Lenalidomide

Lenalidomide: Adverse Reactions

Clinical Features/Presentation

Signs and Symptoms

NMDA Receptor Antagonist - Memantine

Memantine Precautions

Goals of Male Hypogonadism Replacement Therapy

Goals of Treatment for Male Hypogonadism

Approved Parenteral Treatments for Multiple Sclerosis

Approved Parenteral Therapies for RRMS: Extavia

Emerging Hypotheses on Treatment

Immunological Concepts: Monoclonal Antibodies

Novel Oral Anticoagulants: Factor Xa Inhibitors - Apixaban

Apixaban: Warning and Precautions

Clinical Assessment Tools in Psoriasis

Clinical Assessment Tools

Early Stages for Developing a Formulation

Molecular Characterization
Development Timeline
Pre-formulation Studies
Manufacturabi...

Statistical Analysis

p-Values

Atherothrombosis

Superficial Plaque Erosion

Novel Oral Anticoagulants: Direct Thrombin Inhibitors - Dabigatran

Dabigatran: Contraindications, Warnings and Precautions

Novel Oral Anticoagulants: Factor Xa Inhibitors - Rivaroxaban

Rivaroxaban: Warnings and Precautions

Management of Overweight/Obesity

Evidence-Based Guidelines for Management of Overweight/Obesity
Goals Management of Overweight/O...

Management of Overweight/Obesity

DSHEA Weight-Loss Products

Disease Mechanism

Neuronal Impairment

Management of Patients with Atrial Fibrillation

Overview of Strategies and Rate Control

Novel Oral Anticoagulants: Factor Xa Inhibitors - Rivaroxaban

Rivaroxaban: Overview, Indications, Dosage and Administration

Novel Oral Anticoagulants: Factor Xa Inhibitors: Rivaroxaban

Indications, Dosage and Administration

Hypomethylating Agents

Hypomethylating Agents

Standard Agents: Therapeutic Challenges

Enoxaparin: Warnings and Precautions

Hypomethylating Agents

Hypomethylating Agents

Emerging Hypotheses on Treatment

Neurodegeneration: Indirect Neuroprotection

NCCN Guidelines

Risk Category and Current Treatment Strategies
Components of NCCN Guidelines
Therapeutic A...

Management Guidelines

Stroke Centers and Stroke Systems of Care

Current Therapies

Complementary and Alternative Therapies: Complementary and Alternative Medicine (CAM)

Monoclonal Antibodies

Modifying the Monoclonal Antibody
Neutralization of a Circulating Factor
Receptor Blockade...

Hypomethylating Agents

Mechanism of DNA Methylation
Gene Silencing Following DNA Methylation
Hypomethylating Agen...

Hypomethylating Agents

Hypomethylating Agents

Ticlopidine

Ticlopidine: Warnings

Current Therapies

Disease Modifying Therapy (DMT): Approved Treatments for Multiple Sclerosis

Atherothrombosis

Overview: Atherothrombosis
Interactivity: Unstable Plaque
Interactivity: Thrombus Formatio...

What is the Role of Toxicology in Drug Discovery and Development?

Toxicology in the Pharmaceutical Industry
The Role of Toxicology in Drug Discovery and Developm...

Specifications and Sign-off (What are the Different Tox Strategies for Small and Large Molecules?)

Toxicology Studies for Small and Large Molecules

What is the Role of Toxicology in Drug Discovery and Development?

Toxicology in the Pharmaceutical Industry

What is the Role of Toxicology in Drug Discovery and Development?

The Role of Toxicology in Drug Discovery and Development

What is the Role of Toxicology in Drug Discovery and Development?

Toxicology Studies in Drug Development

How Does Toxicity Work?

How Does Toxicity Work?
Drug Distribution
Biotransformation
Chemical Reactions
E...

How Does Toxicity Work?

How Does Toxicity Work?

How Does Toxicity Work?

Drug Distribution

How Does Toxicity Work?

Biotransformation

How Does Toxicity Work?

Chemical Reactions

How Does Toxicity Work?

Exaggerated Pharmacology

How Does Toxicity Work?

Toxin Targets

How Do Drugs Affect The Body?

What is ADME?
Absorption and Distribution
Biotransformation
Local vs. Systemic Respon...

How Do Drugs Affect The Body?

What is ADME?

How Do Drugs Affect The Body?

Absorption and Distribution

How Do Drugs Affect The Body?

Biotransformation

What Is the Relationship Between Dose and Response?

Dose/Response Relationships
Acute and Delayed Response

What Is the Relationship Between Dose and Response?

Dose/Response Relationships

What Is the Relationship Between Dose and Response?

Acute and Delayed Response

How Might Drugs Affect Development?

Male and Female Reproductive Systems
Developmental Toxicity
Development is a Complex Proce...

How Might Drugs Affect Development?

Male and Female Reproductive Systems

How Might Drugs Affect Development?

Developmental Toxicity

How Might Drugs Affect Development?

Development is a Complex Process

How Might Drugs Affect Development?

Thalidomide Action

What is the Role of Toxicology in Drug Development?

Safety Pharmacology

What is the Role of Toxicology in Drug Development?

In Vivo and In Vitro Testing

What Kinds of In Vivo Tests are Used in Toxicology?

In Vivo Test Assumptions
Classes of Test
Cellular Assays
Molecular Assays
In Sil...

What Kinds of In Vivo Tests are Used in Toxicology?

In Vivo Test Assumptions

What Kinds of In Vivo Tests are Used in Toxicology?

Classes of Test

What Kinds of In Vivo Tests are Used in Toxicology?

Cellular Assays

What Kinds of In Vivo Tests are Used in Toxicology?

Molecular Assays

What Kinds of In Vivo Tests are Used in Toxicology?

In Silico Assays

How Do We Identify DNA Toxicants?

In Vitro Tests
In Vivo Tests

How Do We Identify DNA Toxicants?

In Vitro Tests

How Do We Identify DNA Toxicants?

In Vivo Tests

How Do We Study Reproductive Toxicity?

Male and Female Reproductive Toxicity
FDA and EPA Guidelines

How Do We Study Reproductive Toxicity?

Male and Female Reproductive Toxicity

How Do We Study Reproductive Toxicity?

FDA and EPA Guidelines

What Studies are Necessary to File an IND?

Preclinical Study Requirements

Specifications and Sign-off (What are the Different Tox Strategies for Small and Large Molecules?)

Toxicology Studies for Small and Large Molecules
Traditional Drugs

Specifications and Sign-off (What are the Different Tox Strategies for Small and Large Molecules?)

Traditional Drugs

Specifications and Sign-off (What are the Different Tox Strategies for Small and Large Molecules?)

Toxicology Studies for Small and Large Molecules

What Tox Issues Emerge Post-IND?

Changes in Midstream

Types of Data

Types of Data: Identification of Outcome Measurements
Categorical: Binary (Dichotomous) Data

Types of Data

Types of Data: Identification of Outcome Measurements

Types of Data

Categorical: Binary (Dichotomous) Data

Types of Data

Categorical: Ordinal and Nominal Data

Types of Data

Numerical: Continuous Data

Types of Data

Numerical: Discrete Data (Counts of Events)

Types of Data

Influence of Data on Statistical Analysis

Distribution Functions

Gaussian (Normal) and Skew Distributions

Distribution Functions

Exponential Distributions

Distribution Functions

Poisson Distribution

Distribution Functions

Distribution Functions

Statistical Summaries

Data Summaries
Equality Between Ratios
Measures of Location
Interactive Exercise: Mea...

Statistical Summaries

Data Summaries

Statistical Summaries

Equality Between Ratios

Statistical Summaries

Measures of Location
Interactive Exercise: Mean, Mode, Median

Statistical Summaries

Measures of Location

Statistical Summaries

Measures of Spread (Variability): Overview

Statistical Summaries

Measures of Spread (Variability)

Statistical Summaries

Measures of Spread (Variability): Kaplan-Meier Estimates

Treatment Effects

Estimating Treatment Effects
Binary Data

Treatment Effects

Estimating Treatment Effects

Treatment Effects

Binary Data

Treatment Effects

Continuous Data
Discrete or Non-Normal Data
Time-To-Event Data

Treatment Effects

Continuous Data

Treatment Effects

Discrete or Non-Normal Data

Treatment Effects

Time-To-Event Data

Statistical Tests

Statistical Tests

Statistical Tests

P-Values

Statistical Tests

Choosing a P-Value

Statistical Tests

Binary Data

Statistical Tests

Continuous Data

Statistical Tests

Discrete or Non-Normal Data

Statistical Tests

Time-To-Event (Survival) Data

Summary: Clinical Statistics

Types of Data

How Do Drugs Affect The Body?

Local vs. Systemic Responses

Atherosclerosis: Risk Factors

Risk Factors

Atherosclerosis: Risk Factors

Risk Factors

Autoimmune Disease Processes

Consequences of Autoimmune Diseases: TNF-α In Autoimmune Disease: Potential Harm OR Benefit?

Passive Immunization

Solanezumab Phase III

Prognosis

Prognostic Factors: First Interattack Interval
Prognostic Factors: Summary of Prognostic Factor...

Passive Immunization

Bapineuzumab Phase III

Symptomatic Therapies

Symptomatic Therapies

Lenalidomide

Lenalidomide: Proposed Mechanism of Action
Lenalidomide: Overview
Lenalidomide: Indication...

Steroids

Glucocorticoids: Mode of Action
The Anti-Inflammatory Effects of Corticosteroids
Glucocort...

Steroids

Glucocorticoids: Side Effects

Monoclonal Antibodies

Production of Monoclonal Antibodies by Hybridomas
Production of Monoclonal Antibodies in Mammal...

Introduction to Monoclonal Antibodies

Four General Classes of mAb Therapies

Introduction to Monoclonal Antibodies

Antibodies as Therapy
Early Antibody Therapy: Polyclonal Antibodies
Hybridoma Technology: ...

Autoimmune Disease Processes

The Etiology of Autoimmune Disease
The Etiology of Autoimmune Disease: Genetic Factors (Risk)

Autoimmune Disease Processes

Consequences of Autoimmune Diseases: Progression and Destruction in Autoimmune Disorders (Mechanisms...