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Russia, Belarus & Kazakhstan

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Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS,volume 28)

Abstract

The Customs Union of Belarus, Kazakhstan and Russia is a form of trade and economic integration of Belarus, Kazakhstan and Russia which provides a unified customs territory within the mutual trade in goods and does not apply customs duties and economic restrictions, except for special protective, antidumping and countervailing measures. The Republics of Belarus and Kazakhstan and the Russian Federation, in accordance with the Agreement of October 6, 2007, established the Commission of the Customs Union, a single permanent regulatory agency of the Customs Union. At present the Commission of the Customs Union is expected to sign the Agreement on common principles of the circulation of goods and services (which includes drug products). In connection with this Agreement which contains an approach to prepare a unified guidance for BE studies, a plan for document preparation has been approved (a Custom Union BE guidance was approved in May 2017).

Keywords

  • Active pharmaceutical ingredient (API)
  • Acceptance criteria
  • Area under the curve (AUC)
  • Bioavailability (BA)
  • Bioequivalence (BE)
  • Cmax
  • Confidence interval (CI)
  • Elimination rate constant
  • Essentially similar
  • European medicines agency (EMA)
  • Extravascular
  • Fixed-dose combination (FDC)
  • US food and drug administration (FDA)
  • Guidelines
  • Guidances
  • Multisource (generic) pharmaceutical product
  • Mutual recognition procedure (MRP)
  • Pharmaceutical alternatives
  • Pharmacodynamic
  • Pharmacokinetic
  • Dosage form
  • Pharmaceutical equivalence (PE)
  • Proportionally similar dosage forms
  • Regulations
  • Therapeutic equivalence (TE)
  • Tmax
  • Topical
  • Vasoconstrictor assay (VCA)

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Correspondence to I. E. Shohin .

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© 2017 American Association of Pharmaceutical Scientists

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Shohin, I.E., Rozhdestvenskiy, D.A., Medvedev, V.Y., Komarov, T.N., Grebenkin, D.Y. (2017). Russia, Belarus & Kazakhstan. In: Kanfer, I. (eds) Bioequivalence Requirements in Various Global Jurisdictions. AAPS Advances in the Pharmaceutical Sciences Series, vol 28. Springer, Cham. https://doi.org/10.1007/978-3-319-68078-1_8

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