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In this article , US Food and Drug Administration (FDA) scientists give a comprehensive overview of the nanomaterials presently available in the US and the challenges encountered when considering approval of generic (or follow-on) versions of these often complex drug products. More specifically, these challenges encompass ‘establishing active ingredient sameness, equivalence in the drug product physicochemical properties and equivalence in thein vivodrug exposure profiles between innovator and generic drug products’.NEXT ARTICLE
In order to become availible to pateints, drugs need to undergo a number of phases of clinical trials to test their efficacy and safty and to then be authorised by the drug approval organistion in each respective country. This is the FDA in the USA and N...
A generic drug (generic drugs, short: generics) is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended u...