Özdemir N.Yildirim M.2024-04-242024-04-2420041016-5134https://hdl.handle.net/11468/24011Two medicinal product are bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and if their bioavailabilities after administration in the same molar dose are similiar to such degree that their effects, with respect to both efficasy and safety, will be essentially the same. Generic medicinal products have increases because of that, the problems of bioequivalence have looks at. According to FDA and EMEA, a bioequivalence study may also be part of a new animal drug application (NADA) or supplemental NADA for approval of an alternative dosage form, new route of administration, or a significant manufacturing change which may affect drug bioavailability.trinfo:eu-repo/semantics/closedAccessReview Article161244472-s2.0-11844262715N/A