Alternative Methods for Dissolution Profile Comparison in the Dissolution Test

Introduction. The article discusses the problem of assessing the similarity of the dissolution profiles of two batches of the nebivolol. The use of a generally accepted similarity factor for assessing equivalence is unacceptable in some cases, for example, for drugs with a high variability in the va...

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Autors principals: D. P. Romodanovsky, D. V. Goryachev
Format: Artigo
Idioma:Russo
Publicat: LLC Center of Pharmaceutical Analytics (LLC «CPHA») 2021-11-01
Col·lecció:Разработка и регистрация лекарственных средств
Matèries:
dissolution test
dissolution profile
difference factor
similarity factor
model-independent methods for evaluating equivalence
Accés en línia:https://www.pharmjournal.ru/jour/article/view/1080
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