Adaptive designs for IVPT data with mixed scaled average bioequivalence

In vitro permeation tests (IVPT) offer accurate and cost-effective development pathways for locally acting drugs, such as topical dermatological products. For assessment of bioequivalence, the FDA draft guidance on generic acyclovir 5% cream introduces a new experimental design, namely the single-do...

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Veröffentlicht in:	Pharmaceutical statistics : the journal of the pharmaceutical industry 2023-11, Vol.22 (6), p.1116-1134
Hauptverfasser:	Lim, Daeyoung, Rantou, Elena, Kim, Jessica, Choi, Sungwoo, Choi, Nam Hee, Grosser, Stella
Format:	Artikel
Sprache:	eng
Schlagworte:	Bioequivalence Computer Simulation Drugs, Generic Humans Hypothesis testing Research Design Sample Size Therapeutic Equivalency
Online-Zugang:	Volltext
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