RECENT TRENDS IN PHARMACUETICAL REVERSE ENGINEERING

According to the definition established by the FDA, a generic drug is “a drug product which is comparable to a reference listed drug (RLD) product in dosage form, strength, route of administration, quality, performance characteristics, and intended use”. Rigorous rules and regulations pertaining to abbreviated new drug application (ANDA) submissions are complex and the generic drug industry strives to meet these regulations to obtain FDA’s approval. And being the “first to file” is the most fundamental principle in the generics business because several companies compete to create generics of successful products going off patent. Therefore, generics companies must be highly skilled and disciplined in product development and achieving bioequivalence—the most critical development area.