Drug bioequivalence and its clinical importance
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Tarih
2004
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Dergi ISSN
Cilt Başlığı
Yayıncı
Erişim Hakkı
info:eu-repo/semantics/closedAccess
Özet
Two 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.
Açıklama
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SENDROM
WoS Q Değeri
Scopus Q Değeri
N/A
Cilt
16
Sayı
12
