Transcription of COMPARISON OF DISSOLUTION PROFILES: …
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Docencia 507. COMPARISON OF DISSOLUTION PROFILES: current guidelines . , , Dpto. Farmacia y Tecnolog a Farmac utica, Facultad de Farmacia, Univ. Complutense de Madrid, Espa a. Introduction across the gastrointestinal tract. Because of the critical nature of the first two steps, in vitro COMPARISON of therapeutic performances of two DISSOLUTION may be relevant to the prediction of medicinal products cantaining the same active in vivo performance. substance is a critical means of assessing the possibility of alternative using between the The BCS can be used as a basis for setting in innovator and any essentially similar medicinal vitro DISSOLUTION specifications and can also product. Assuming that in the same subject an provide a basis for predicting the likelihood of essentially similar plasma concentration time achieving a successful in vivo-in vitro course will result in essentially similar correlation (IVIVC). Based on drug solubility concentration at the site of action and thus in and permeability, the BCS is recommended: an essentially similar effect, pharmacokinetic (2): data instead of therapeutic results may be used - Case 1: High Solubility High to establish equivalence: bioequivalence.
Docencia 507 COMPARISON OF DISSOLUTION PROFILES: CURRENT GUIDELINES A.Prior, P.Frutos, C.P.Correa Dpto. Farmacia y Tecnología Farmacéutica, Facultad de …
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