Current Criteria for Studies of Drug Bioequivalence: Harmonization of National Standards

Author:

Smirnov A. S.,Schneider A.,Frolov M. Yu.,Petrov V. I.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmacology

Reference79 articles.

1. Qualitative Studies of the Bioequivalence of Medicines. Methodological Guidelines of the Ministry of Health and Social Development of the Russian Federation [in Russian], issued August, 2004, Moscow (2004).

2. European Guideline on the Investigation of Bioequivalence, CPMP / EWP / QWP / 1401 / 98 Rev. 1 / Corr *

3. Guidance for industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations, U. S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), March, Roñkville, MD (2003).

4. K. Nakai, M. Fujita, and H. Ogata, Yakugaku Zasshi, 120, 1193 – 1200 (2000).

5. E. Diletti, D. Hauschke, and V. W. Steinijans, Int. J. Clin. Pharmacol. Ther. Toxicol., 29, 1 – 8 (1991).

Cited by 3 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

1. Planning and Evaluation of Bioequivalence Studies of Enalapril Products;The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products;2018-12-20

2. Planning Bioequivalence Studies of Drugs with Narrow Therapeutic Indices;Pharmaceutical Chemistry Journal;2017-03

3. Development of Clinical Pharmacology in the Russian Federation;Clinical Therapeutics;2016-05

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