What are some special considerations made by you

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Question: 7 Many Development-stage toxicology studies are fairly standard; though, there are some that are designed on a case by case basis. Under these conditions, it is very important to get agreement from FDA (or the appropriate Regulatory Authority) regarding the study design. Name such a situation, a particular study where Regulatory agreement would be important. What are some special considerations made by you, the investigator to rationalize your study design details.

Reference no: EM133477183

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