Drug Metabolism in Drug Development: A DIA Tutorial for Regulatory Affairs Specialists

Many drug metabolism, drug-drug interaction, and pharmacogenetics meetings are held each year and are well attended by scientists from the pharmaceutical industry, academia, and worldwide regulatory agencies. Personal communication indicated that large amounts of drug metabolism information passed a...

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Bibliographic Details
Published in:Drug information journal 1998-01, Vol.32 (1), p.163-167
Main Authors: Honig, Peter K., Cantilena, Louis R., Santone, Kenneth S.
Format: Article
Language:English
Subjects:
Biological and medical sciences
Clinical trial. Drug monitoring
Drug development
Drug interaction
Drug interactions
Drug metabolism
General pharmacology
In vivo methods and tests
Medical sciences
Metabolism
Nomenclature
Personal communication
Pharmaceutical industry
Pharmacogenetics
Pharmacology. Drug treatments
Regulatory agencies
Citations: Items that this one cites
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Summary:Many drug metabolism, drug-drug interaction, and pharmacogenetics meetings are held each year and are well attended by scientists from the pharmaceutical industry, academia, and worldwide regulatory agencies. Personal communication indicated that large amounts of drug metabolism information passed across the desks of the regulatory affairs specialists either as reports being submitted to or as information requests from regulatory agencies and that, unlike other preclinical or clinical data, there was little appreciation of the meaning or relevance of such information to the overall drug development campaign. The purpose of the tutorial described here was to allow regulatory affairs specialists to gain a working appreciation of the nomenclature, techniques, and usefulness of in vitro and in vivo drug metabolism studies.
ISSN:2168-4790
0092-8615
2168-4804
2164-9200
DOI:10.1177/009286159803200123