DRUG DISCOVERY DEVELOPMENT (DDD): 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

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

LEIGHTON DWIGHT OBILLOS · Accepted Answer

Abbreviated New Drug Application (ANDA)

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