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From course:

DRUG DISCOVERY DEVELOPMENT (DDD)

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Question:

STUDY ENROLLMENT CRITERIA should be written with consideration of the following:

Author: LEIGHTON DWIGHT OBILLOS



Answer:

(1) BACKGROUND RISKS associated with the disease or condition studied (2) PREVIOUS KNOWLEDGE OF TOXICITIES of the investigational drug observed in animal studies or with human experience (3) WARNINGS AND PRECAUTIONS described in the product’s label (when approved products are investigated for other than approved uses) BPW


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