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

44• •• •• •Heart*Duodenum(Rectum)• •• • Aorta • •• •JejunumEpididymisTestis*• • Skin • •s• •OesophaguTerminalileum• • Liver* • •• •MammaryKidney*• •Ovary• •Mesenteric• •Stomach• • Colon• • Urinarybladder• • Uterus*• •Skeletalglandlymph node muscle* Organs marked with an asterisk should be weighed.() Organs listed in parenthesis should be examined if indicated by the nature of the drug orobserved effects.Non-clinical toxicity testing and safety evaluation data of an IND needed for the conduct ofdifferent phases of clinical trialsNote: Refer Appendix III (Points 1.1 through 1.7 and tables 1.8 and 1.9) for essential featuresof study designs of the non-clinical toxicity studies listed below.For Phase I Clinical TrialsSystemic Toxicity studiesi. Single dose toxicity studiesii. Dose Ranging Studiesiii. Repeat-dose systemic toxicity studies of appropriate duration to support the duration tosupport the duration of proposed human exposure.Male fertility studyIn-vitro genotoxicity testsRelevant local toxicity studies with proposed route of clinical application (durationdepending on proposed length of clinical exposure)