JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD B.Pharmacy IV EXPERIMENTAL PHARMACOLOGY Previous Question Paper (July-2021 - R17)

Teratogenicity testing involves evaluating the potential of a substance to cause developmental abnormalities in the fetus when administered to pregnant animals. These studies are typically conducted in two species, such as rats and rabbits. The test substance is administered during the period of organogenesis, which is the most sensitive phase of embryonic development. The dams are sacrificed shortly before the expected delivery date, and the fetuses are examined for external, visceral, and skeletal malformations. The objective is to identify the no-observed-adverse-effect level (NOAEL) and characterize the dose-response relationship for developmental toxicity.

Alternatives to animal experiments are guided by the 3Rs principle: Replacement, Reduction, and Refinement. Replacement involves using non-animal models such as in vitro cell cultures, organ-on-a-chip technology, computer-based in silico modeling, and mathematical simulations. Reduction focuses on optimizing experimental designs to obtain statistically significant data using the minimum number of animals. Refinement aims to minimize pain and distress through improved housing, handling, and the use of anesthesia or analgesia during procedures.