Learning unit: Preclinical trials


Impact of the learning unit:

This unit aims to introduce the processes of drug research and development before a new medicine
enters clinical trials. Physicians are also experts on drugs, and thus, basic information about the
preclinical phase of research is considered as general pharmacological knowledge. This information
may also help with the future involvement in either academic or commercial preclinical research.


Relevant terms

life cycle of a drug

in silico methods in drug development

in vitro techniques of drug testing

molecular pharmacology

cell line (cell culture)

isolated organ

animal model

experimental animal, species

principle of 3R, Project of animal experiments

toxicological testing of new drugs

                acute, subchronic, chronic toxicity

                lethal dose test

                skin toxicity

                mutagenicity, carcinogenicity

                teratogenicity


Learning outcomes

The student is able to summarize and explain the course of testing before a new drug enters
clinical practice. Student describes the life cycle of a drug.

The student is knowledgeable about the issue of preclinical research, explains the aim of animal
use in drug development and essential ethic principles.

Study materials

Rang & Dale's Pharmacology, 8th edition, 2016, chapter 60, pp. 718-722

Study materials for courses aVLFA0721p and aVLFA0721c.


Exam questions

General pharmacology: 3. Preclinical and clinical trials, stages