Kefauver-Harris Drug Amendments 1962
The amendment was a response to the Thalidomide tragedy, in which thousands of children were born with birth defects as
Clinical Trial
Clinical Trial [Syn. clinical investigation, clinical study] is any systematic and carefully designed study on medicinal products in human subjects
Biosimilar Medicines
Unlike generic medicines where the active ingredients are identical, biosimilars – by definition – are not likely to be identical
Embracing Quality by Design (QbD) in Pharmaceutical Industry
Year 2002, the U.S. Food and Drug Administration (FDA) published a concept paper on current good manufacturing practice for 21st