Current Criteria for Studies of Drug Bioequivalence: Harmonization of National Standards

Autor:	V. I. Petrov, M. Yu. Frolov, A. Schneider, A. S. Smirnov
Rok vydání:	2014
Předmět:	Pharmacology Chemistry business.industry media_common.quotation_subject Control (management) Legislation Pharmacy Accounting Harmonization Bioequivalence Drug bioequivalence Drug Discovery Normative Quality (business) business media_common
Zdroj:	Pharmaceutical Chemistry Journal. 48:303-309
ISSN:	1573-9031 0091-150X
DOI:	10.1007/s11094-014-1099-2
Popis:	Harmonization of national standards for drugs is one of the most relevant contemporary tasks for states, and the importance of this task for Russia increased with entry into the World Trade Organization (WTO). Apart from laws regulating medicines, a large body of subordinate legislation also requires review and updating. The guidelines for studies of drug bioequivalence are among the definitive normative documents for drug registration and quality control. The expert and medical communities are of the view that the current Russian guidelines do not meet international requirements and require revision. Some of the international criteria used in studies of drug bioequivalence are presented here. With the aim of increasing the quality of medicines on the Russian pharmaceutical market, we discuss current and proposed additional indicators for studies of bioequivalence for amendments and additions to allow documents to reach international standards.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::16da1ebc7b115681714ed6d6d0305063 https://doi.org/10.1007/s11094-014-1099-2 Zobrazit plný text záznamu Plný text ve formátu PDF