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

46Repeat-dose systemic toxicity studies of appropriate duration to support the durationof proposed human exposureReproductive/developmental toxicity studiesSegment I (if female patients of child bearing age are going to be involved), andSegment III (for drugs to be given to pregnant or nursing mothers or where there areindications of possible adverse effects on foetal development)Carcinogenicity studies (when there is a cause for concern or when the drug is to beused for more than 6 months)For Phase IV Clinical TrialsProvide a summary of all the non-clinical safety data (listed above) already submittedwhile obtaining the permissions for Phase I, II and III trials, with appropriate references.In case an application is made for initiating the Phase IV trial, complete details of thenon-clinical safety data needed for obtaining the permissions for Phase I, II and IIItrials, as per the list provided above must be submitted.Application Of Good Laboratory Practices (GLP)The animal studies be conducted in an accredited laboratory. Where the safety pharmacologystudies are part of toxicology studies, these studies should also be conducted in an accreditedlaboratory.Appendix IVANIMAL PHARMACOLOGY1. General Principles