Biopharmaceutics Classification System

Biopharmaceutics Classification System: A Regulatory Approach

32 Dissolution Technologies | FEBRUARY 2011 the management of product change through its life cycle. In early drug development, knowledge of the class of a …

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Relationships between Lipophilicity and Solubility

Relationships between Lipophilicity and Solubility Karl J. Box Physical Chemistry Symposium Nov 29th 2006 Sirius Analytical Instruments Limited

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Toward Biorelevant Dissolution: Application of a Biphasic ...

Dissolution Technologies | FEBRUARY 2012 25 e-mail: james_mann@merck.com Toward Biorelevant Dissolution: Application of a Biphasic Dissolution Model as a Discriminating Tool for HPMC Matrices

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COMPARISON OF DISSOLUTION PROFILES: CURRENT …

Docencia 507 COMPARISON OF DISSOLUTION PROFILES: CURRENT GUIDELINES A.Prior, P.Frutos, C.P.Correa Dpto. Farmacia y Tecnología Farmacéutica, Facultad de Farmacia ...

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MULTISOURCE (GENERIC) PHARMACEUTICAL PRODUCTS: …

Working document QAS/14.583/Rev.1 page 3 43 BACKGROUND 44 Over the course of time and especially in view of the implementation of the existing 45 guidelines 1 the users have indicated that there was a need to review and update certain 46 requirements.

  Pharmaceutical, Generic, Multisource

PROPOSAL TO WAIVE IN VIVO BIOEQUIVALENCE …

working document qas/04.109/rev.1 page 1 world health organization organisation mondiale de la sante proposal to waive in vivo bioequivalence requirements for the …

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EMA versus US-FDA regulatory requirements regarding ...

EMA versus US-FDA regulatory requirements regarding bioequivalence of orally administered generics Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels "Master of Drug Regulatory Affairs"