3 In the Drugs and Cosmetics Rules, 1945 - amam-ayurveda.org

47Specific and general pharmacological studies should be conducted to supportuse of therapeutics in humans. In the early stages of drug development enoughinformation may not be available to rationally select study design for safetyassessment. In such a situation, a general approach to safety pharmacologystudies can be applied. Safety pharmacology studies are studies thatinvestigate potential undesirable pharmacodynamic effects of a substance onphysiological functions in relation to exposure within the therapeutic range orabove.1.1 Specific Pharmacological ActionsSpecific pharmacological actions are those which demonstrate the therapeuticpotential for humans.The specific studies that should be conducted and their design will be different basedon the individual properties and intended uses of investigational drug. Scientificallyvalidated methods should be used. The use of new technologies and methodologies inaccordance with sound scientific principles should be preferred.1.2 General Pharmacological Actions1.2.1 Essential Safety PharmacologySafety pharmacology studies need to be conducted to investigate the potential undesirablepharmacodynamic effects of a substance on physiological functions in relation to exposurewithin the therapeutic range and above. These studies should be designed to identifyundesirable pharmacodynamic properties of a substance that may have relevance to its humansafety; to evaluate adverse pharmacodynamic and/or pathophysiological effects observed intoxicology and/or clinical studies; and to investigate the mechanism of the adversepharmacodynamic effects observed and/or suspected.The aim of the essential safety pharmacology is to study the effects of the test drug on vitalfunctions. Vital organ systems such as cardiovascular, respiratory and central nervous systemsshould be studied. Essential safety pharmacology studies may be excluded or supplemented