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Planning and Evaluation of Bioequivalence Studies of Drugs with Nonlinear Pharmacokinetics

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

A bioequivalence (BE) study is one of the key stages of investigations required for the registration of oral generic drugs. The planning of this type of study is determined by many factors, including the linearity of the pharmacokinetics of the active substance. The choice of the drug dose for a BE study will depend on this property in registering several drug strengths. Regulatory requirements for planning BE studies of drugs with non-linear pharmacokinetics are considered using atazanavir and valaciclovir as examples. An analysis of protocols and reports of BE studies received by the SCEEMP according to the State Drug Registry and open published data on BE revealed differences in both the tested drug dosages and the number of tests performed. All characteristics of the given active substance, available literature data, international experience, and current regulatory requirements should be taken into account in planning and evaluating BE studies of drugs with non-linear pharmacokinetics.

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Acknowledgments

The work was performed in the framework of a state task for SCEEMP, Ministry of Health of Russia, No. 056-00154-19-00 for applied scientific research (State Accounting No. NIR AAAA-A18-118021590049-0).

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Authors and Affiliations

  1. Scientific Center for Expert Evaluation of Medicinal Products (SCEEMP), Ministry of Health of the Russian Federation, 8/2 Petrovskii Blvd, Moscow, 127051, Russia

    N. E. Uvarova, N. N. Eremenko, G. V. Ramenskaya & D. V. Goryachev

  2. I. M. Sechenov First Moscow State Medical University (Sechenov University, Ministry of Health of the Russian Federation, 8/2 Trubetskaya St, Moscow, 119991, Russia

    N. N. Eremenko & G. V. Ramenskaya

Authors
  1. N. E. Uvarova
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  2. N. N. Eremenko
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  3. G. V. Ramenskaya
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  4. D. V. Goryachev
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Correspondence to N. E. Uvarova.

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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 55, No. 1, pp. 3 – 7, January, 2021.

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Uvarova, N.E., Eremenko, N.N., Ramenskaya, G.V. et al. Planning and Evaluation of Bioequivalence Studies of Drugs with Nonlinear Pharmacokinetics. Pharm Chem J 55, 1–5 (2021). https://doi.org/10.1007/s11094-021-02361-9

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  • DOI: https://doi.org/10.1007/s11094-021-02361-9

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