Guest guest Posted December 6, 2010 Report Share Posted December 6, 2010 Respected members, Moving ahead in our discussion, we will go through some of the steps in manufacture of a new drug. a. Source, Synthesis & Chemistry b. Preclinical studies c. Toxicity studies d. Regulatory approval e. Phase I, II, III clinical trials f. Marketing permission g. Phase IV clinical trial Here we see that preclinical( animal) toxicity studies are to be done in the very preliminary stages , even before its regulatory approval by DCGI. Dr Somesh RayasamJR,Pharmacology dept,GMCH, Nagpur. Quote Link to comment Share on other sites More sharing options...
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