Email this article Practical Issues of Preclinical Pharmacokinetic Investigations of New Drugs (Review)
- Authors: Chistyakov V.V.1, Stepanova E.S.1
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Affiliations:
- People’s Friendship University of Russia, Common Use Center
- Issue: Vol 53, No 4 (2019)
- Pages: 281-287
- Section: Molecular-Biological Problems of Drug Design and Mechanism of Drug Action
- URL: https://ogarev-online.ru/0091-150X/article/view/245740
- DOI: https://doi.org/10.1007/s11094-019-01995-0
- ID: 245740
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Abstract
Several issues with pharmacokinetic studies of new drugs, in particular, experiment planning, development of study protocols, dose selection, and administration routes, are reviewed. The number of used animals is justified statistically with respect to bioethics. The pharmacokinetic study protocol is discussed in more detail according to domestic regulatory requirements. Modern approaches to combining bioanalytical methods with pharmacokinetic studies are described.
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About the authors
V. V. Chistyakov
People’s Friendship University of Russia, Common Use Center
Email: stepanova_25@inbox.ru
Russian Federation, Moscow, 117198
E. S. Stepanova
People’s Friendship University of Russia, Common Use Center
Author for correspondence.
Email: stepanova_25@inbox.ru
Russian Federation, Moscow, 117198
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