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Practical Issues of Preclinical Pharmacokinetic Investigations of New Drugs (Review)

  • MOLECULAR-BIOLOGICAL PROBLEMS OF DRUG DESIGN AND MECHANISM OF DRUG ACTION
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Pharmaceutical Chemistry Journal Aims and scope

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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Acknowledgments

The work was sponsored by RUDN Program 5 – 100.

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Authors and Affiliations

  1. People’s Friendship University of Russia, Common Use Center, Moscow, 117198, Russia

    V. V. Chistyakov & E. S. Stepanova

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  1. V. V. Chistyakov
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  2. E. S. Stepanova
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Correspondence to E. S. Stepanova.

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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 53, No. 5, pp. 3 – 9, May, 2019.

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Chistyakov, V.V., Stepanova, E.S. Practical Issues of Preclinical Pharmacokinetic Investigations of New Drugs (Review). Pharm Chem J 53, 281–287 (2019). https://doi.org/10.1007/s11094-019-01995-0

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  • DOI: https://doi.org/10.1007/s11094-019-01995-0

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