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Modern Approaches to the Development of Reference Standards for Quality Assessment of Drug Substances
- Source :
- Pharmaceutical Chemistry Journal. 49:776-778
- Publication Year :
- 2016
- Publisher :
- Springer Science and Business Media LLC, 2016.
-
Abstract
- Reference standards, including pharmacopoeial reference standards, are widely used for quality assessment of drug substances. Leading global pharmacopoeias contain monographs regulating the requirements for the classification, attestation, and use of reference standards. The drug standardization system in the Russian Federation, which includes drug substances, requires revision for the creation and attestation of national reference standards, including pharmacopoeial ones.
- Subjects :
- Pharmacology
Drug
Standardization
010405 organic chemistry
Quality assessment
business.industry
Chemistry
media_common.quotation_subject
Pharmacology toxicology
Pharmacy
01 natural sciences
0104 chemical sciences
law.invention
Toxicology
010404 medicinal & biomolecular chemistry
law
Drug Discovery
Russian federation
Engineering ethics
Pharmacopoeia
business
Reference standards
media_common
Subjects
Details
- ISSN :
- 15739031 and 0091150X
- Volume :
- 49
- Database :
- OpenAIRE
- Journal :
- Pharmaceutical Chemistry Journal
- Accession number :
- edsair.doi...........ce9c9cb165cf6533503033c248d7a3f1