Drug bioequivalence and its clinical importance

dc.contributor.authorÖzdemir N.
dc.contributor.authorYildirim M.
dc.date.accessioned2024-04-24T17:58:36Z
dc.date.available2024-04-24T17:58:36Z
dc.date.issued2004
dc.departmentDicle Üniversitesien_US
dc.description.abstractTwo 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.en_US
dc.identifier.endpage47en_US
dc.identifier.issn1016-5134
dc.identifier.issue12en_US
dc.identifier.scopus2-s2.0-11844262715en_US
dc.identifier.scopusqualityN/Aen_US
dc.identifier.startpage44en_US
dc.identifier.urihttps://hdl.handle.net/11468/24011
dc.identifier.volume16en_US
dc.indekslendigikaynakScopus
dc.language.isotren_US
dc.relation.ispartofSENDROMen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.titleDrug bioequivalence and its clinical importanceen_US
dc.title.alternativeİlaçlarda biyoeşde?erlilik ve klinik önemien_US
dc.typeReview Articleen_US

Dosyalar