SMi Source lesson Drug R&D: Toxicology Applications has the following microlearning topics
1. What is the Role of Toxicology in Drug Development?
2. What Kinds of In Vivo Tests are Used in Toxicology?
3. How Do We Identify DNA Toxicants?
4. How Do We Study Reproductive Toxicity?
5. Preclinical Study Requirements
6. Specifications and Sign-off (What are the Different Tox Strategies for Small and Large Molecules?)
7. Changes in Midstream
Lesson Drug R&D: Toxicology Applications teaches these concepts
Applications of Toxicology, What is the Role of Toxicology in Drug Development?, How Does Toxicology Relate to the Pre-Clinical Road Map?
Applications of Toxicology, What is the Role of Toxicology in Drug Development?, Safety Pharmacology
Applications of Toxicology, What is the Role of Toxicology in Drug Development?, In Vivo and In Vitro Testing
Lesson Drug R&D: Toxicology Applications addresses these key points
How Does Toxicology Relate to the Pre-Clinical Road Map?
- Toxicology
- Rodent and nonrodent
- Route, duration and timing
- Drug Metabolism and Pharmacokinetics (PKDM)
- Absorption
- Distribution
- Metabolism
- Excretion
- Chemistry, Manufacturing and Control (CMC)
- Synthesis and manufacturing specifications
- In process controls
- Product stability controls
- Preclinical Toxicology Studies (via FDA regulations)
- Acute Single Dose Toxicity
- Dose-range Finding Toxicity
- Repeat Dose Toxicity
- Genotoxicity Battery
Safety Pharmacology
- Cardiovascular safety assays
- A CNS activity profile
- Pulmonary function tests
- Insight into adverse effects
- Clinical preview
- Side effects
- hERG potassium ion channel binding assay
In Vivo (In animals)
- Expensive
- Not feasible for large numbers of compounds
In Vitro (In an artificial environment)
- Useful alternative for understanding properties of compounds
- In vivo effects may be different from in vitro effects