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- Title
Current Problems of Drug Expertise and Standardization.
- Authors
Bagirova, V.; Kovaleva, E.; Shanazarov, K.
- Abstract
Currently important issues of the expertise and standardization of medicinal products are discussed, including difficulties encountered in expert evaluation of the pharmacopoeial articles of domestic manufacturers and the normative documentation for imported drugs. The need for increasing the requirements on existing quality control methods and for the development of new ones for drug testing with respect to crystallinity, grain size, and polymorphic modifications is shown. Some features of quality control of novel drugs and generics are discussed.
- Subjects
STANDARDIZATION; QUALITY control; DRUGS; GENERIC drugs; DRUG use testing; QUALITY assurance
- Publication
Pharmaceutical Chemistry Journal, 2005, Vol 39, Issue 6, p333
- ISSN
0091-150X
- Publication type
Article
- DOI
10.1007/s11094-005-0147-3