v. To determine the route of administration.
Non-clinical Drug Development Process (Figure 8.2)
Fig. 8.2: Non-clinical drug development
Drug Development and Non-Clinical Studies 125
There are two types of non-clinical study. These are:
1. Pharmacodynamics (What drug does to the body or how the drug makes the body
2. Pharmacokinetics (What the body does to the drug?)
The main objective of this study is to determine the effect of the compound on the
target organ. These can be done either in vitro or in vivo or both.
The main objective of this study is to determine the effect of the compound on organs
This study helps in determining the lethal dose of the compound. Its main objective is
also to determine undesirable effects of the compound within the therapeutic dose
range or higher dose. Mainly the undesirable effects on CNS, cardiovascular system
and respiratory system are determined (Fig. 8.3).
The main aim of this study is to determine parameters related to absorption,
distribution, metabolism and excretion of compound. This study also deals with
toxicokinetics (to determine where and when undesirable effects occur due to
Fig. 8.3: Types of non-clinical studies
This study helps in determine the toxicity of the compound (Fig. 8.4).
Fig. 8.4: Factors lead to the stopping of the development of the compound
Sr. no. Name of study Objective
1. Single-dose and dose-range To identify target organ of toxicity
finding studies To determine the reversibility of the toxic effect.
Establish the dose for future reference
To determine the maximum tolerated dose.
To determine non-observed adverse effect level.
2. Genotoxicity To detect possible interactions with chromosomes and
To detect any gene mutation or chromosomal damage.
3. Carcinogenicity To detect if the compound causes cancer.
4. Reproductive and To study the effect on
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