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FDA Safety and  Form

FDA Safety and Form

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hello everybody here and online my talk is going to be different from what you heard up to now these are the things that I'm going to be talking about you know you've heard some of them but I'm going to be talking from a pharmacology toxicology non clinical reviewer points about all those issues so the drug review process is a multidisciplinary stepwise process involving evaluation of animal and human safety and efficacy data it is very important to have evaded evidence of safety and efficacy for every drug it's not really ethical to get a drug on the market that doesn't have is not safe or is not efficacious so the forum talks reviewer or non clinical reviewer assesses the safety data that is submitted by the sponsor so the stages of drug development as you heard and are probably you all know we start from pre-ind everybody is talking about pre-ind so that tells you how important is pre-ind IND which covers phase one phase two and phase three clinical trials the NDA and post marketing

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