Principles of Preclinical Studies

List of Practicals

1. Handling, restraining, and sex differentiation of laboratory animals (demo/video)
2. Calculation of dose for animals based on body surface area
3. Routes of administration: oral, intraperitoneal, subcutaneous (simulation)
4. Observation of behavioral effects using actophotometer/rotarod (if available)
5. Determination of acute toxicity (LD50 concept) – case-based calculation
6. Planning a 28-day sub-acute toxicity study protocol
7. Pharmacokinetic study: Cmax, Tmax, AUC calculation (sample dataset)
8. Observation of histopathological slides from toxicity studies
9. Demonstration of sampling methods – blood, urine (case or video)
10. Writing an animal study protocol using CPCSEA format
11. Identification of organs for toxicity evaluation – liver, kidney, brain
12. Visit to CPCSEA-approved animal house/laboratory
13. Observation of animal behavior – grooming, nesting (case-based)
14. Simulated ethics committee approval process (IAEC)
15. Group activity: Design of a preclinical study for a hypothetical drug *PCI recommended software’s shall be used for performing experiments.