Russia, Belarus & Kazakhstan

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).

Авторы
Shohin I.E.1 , Rozhdestvenskiy D.A.2 , Medvedev V.Y.1 , Komarov T.N.1 , Grebenkin D.Y. 3
Издательство
SPRINGER
Язык
Английский
Страницы
199-227
Статус
Опубликовано
Том
28
Год
2017
Организации
  • 1 Ctr Pharmaceut Analyt Ltd, 20 Nauchniy Proezd, Moscow 117246, Russia
  • 2 Ctr Examinat & Tests Hlth Serv State Enterprise, 2a Tovarishesky Lane, Minsk 220037, BELARUS
  • 3 Peoples Friendship Univ Russia, Inst Biochem Technol & Nanotechnol, 10-2 Miklukho Maklaya St, Moscow 117198, Russia
Ключевые слова
Active pharmaceutical ingredient (API); Acceptance criteria; Area under the curve (AUC); Bioavailability (BA); Bioequivalence (BE); C-max; 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); T-max; Topical; Vasoconstrictor assay (VCA)
Дата создания
04.02.2019
Дата изменения
05.02.2019
Постоянная ссылка
https://repository.rudn.ru/ru/records/article/record/36778/
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