Modern approaches to the assessment of orally inhaled products bioequivalence

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Modern approaches to the assessment of orally inhaled products bioequivalence

The article analyses regulatory documents containing requirements for clinical (trials) documentation for orally inhaled products, including requirements for the demonstration of therapeutic equivalence of medicinal products for the treatment of bronchial asthma and chronic obstructive pulmonary dis...

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Bibliographic Details
Main Authors:	E. S. Petrova, D. V. Goryachev, M. V. Petrov
Format:	Article
Language:	Russian
Published:	Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-02-01
Series:	Регуляторные исследования и экспертиза лекарственных средств
Subjects:	ингаляционные лекарственные препараты ингаляционные устройства фармакокинетика фармакодинамика биоэквивалентность терапевтическая эквивалентность конечные точки клинических исследований критерии оценки эффективности и безопасности orally inhaled products inhalation devices pharmacokinetics pharmacodynamics bioequivalence therapeutic equivalence primary endpoints of clinical trials efficacy and safety criteria
Online Access:	https://www.vedomostincesmp.ru/jour/article/view/132
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