Current Approaches to Demonstration of Therapeutic Equivalence of Locally-Acting Gastrointestinal Drugs

Evolution of knowledge about pharmacokinetics and pharmacodynamics of locally acting products, and an increase in the number of generics and medicines under development have laid the ground for the development of new scientific approaches to planning and conducting of therapeutic equivalence studies...

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Hlavní autoři:	E. V. Gorbunova, D. V. Goryachev, T. E. Gorskaya, A. N. Bogdanov
Médium:	Artigo
Jazyk:	Russo
Vydáno:	Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2021-12-01
Edice:	Регуляторные исследования и экспертиза лекарственных средств
Témata:	clinical study medicinal product authorisation locally acting gastrointestinal products mesalazine bioequivalence therapeutic equivalence reference product in vitro dissolution kinetics test
On-line přístup:	https://www.vedomostincesmp.ru/jour/article/view/380
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