An Overview of Drug Master Files
نویسندگان
چکیده
منابع مشابه
Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence.
PURPOSE A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP) to identify similarities and differences among ASMF/DMF procedures of 10 IGDRP members and 2 observers. METHODS We conducted a questionnaire s...
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متن کاملOverview of National Drug Policy of Iran
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ژورنال
عنوان ژورنال: Pharmaceutical Regulatory Affairs: Open Access
سال: 2018
ISSN: 2167-7689
DOI: 10.4172/2167-7689.1000198