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From course:

DRUG DISCOVERY DEVELOPMENT (DDD)

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Question:

Generic products MUST BE BIOEQUIVALENT in comparison to approved proprietary drug FOCUS on BIOEQUIVALENCE TESTING than safety and efficacy Bioquievalent - rate and extent of drug absorption must be within established parameters to the reference drug

Author: LEIGHTON DWIGHT OBILLOS



Answer:

Abbreviated New Drug Application (ANDA)


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