Current status of the international comparator (reference) product system

Since 1993, WHO's Division of Drug Management and Policies has been working with drug regulatory authorities from some 20 countries, the pharmaceutical industry--including both research-based as well as generic industry--and academia to set up requirements and specifications for multisource (ge...

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Bibliographic Details
Published in:European journal of drug metabolism and pharmacokinetics 2000-01, Vol.25 (1), p.36-37
Main Author: IDÄNPÄÄN-HEIKKILÄ, Juhana E
Format: Article
Language:English
Subjects:
Biological and medical sciences
Drugs, Generic - pharmacokinetics
Drugs, Generic - standards
General pharmacology
Humans
Medical sciences
Pharmacokinetics. Pharmacogenetics. Drug-receptor interactions
Pharmacology. Drug treatments
Reference Standards
Reference Values
Therapeutic Equivalency
World Health Organization
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Summary:Since 1993, WHO's Division of Drug Management and Policies has been working with drug regulatory authorities from some 20 countries, the pharmaceutical industry--including both research-based as well as generic industry--and academia to set up requirements and specifications for multisource (generic) pharmaceutical products (1). One important area has been the development of an international list of comparator (reference) products for equivalence testing. This has become increasingly necessary as the manufacture, regulatory approvals and use of the generic pharmaceutical products have increased world-wide. In order to save time and resources in product development and to avoid duplication of unnecessary bioavailability testing in humans, it has been suggested that an internationally agreed comparator product system would be helpful. Moreover, any exposure of a human being to a pharmaceutical product in equivalence testing may carry a health risk and may consequently be considered unethical.
ISSN:0378-7966
2107-0180
DOI:10.1007/BF03190055