Document Detail


Current opinion: safety evaluation of drug metabolites in development of pharmaceuticals.
MedLine Citation:
PMID:  17965548     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Safety assessment of drug metabolites in the development of pharmaceuticals was discussed in January 2007 at the kick-off meeting of a "Drug Evaluation Forum", with reference to the views of clinicians and other academic representatives. Safety evaluation of metabolites cannot readily be based on a single theoretical framework, and basically a case-by-case approach is called for. These evaluations should be performed precisely and an accurate profile secured taking into account adverse reactions that are unpredictable from the parent compound administered in clinical studies and any signs or symptoms that may be associated with the metabolites. In addition, elimination of scientifically meaningless metabolite safety assessment studies is essential for prompt supply of high-quality drugs to the medical frontline. Preparation of an outline concept paper would be useful for achievement of shared understanding of issues of this type. Collective viewpoints obtained in this fashion are also relevant to the discussion on the need for guidance, and given a degree of flexibility may also be helpful for drug development and, in turn, society at large.
Authors:
Shinsaku Naito; Shigeru Furuta; Takemi Yoshida; Mitsukazu Kitada; Osamu Fueki; Takashi Unno; Yasuo Ohno; Hiroshi Onodera; Nobuyuki Kawamura; Misao Kurokawa; Fumio Sagami; Kazutoshi Shinoda; Takahiro Nakazawa; Tsuneyoshi Yamazaki
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  The Journal of toxicological sciences     Volume:  32     ISSN:  0388-1350     ISO Abbreviation:  J Toxicol Sci     Publication Date:  2007 Oct 
Date Detail:
Created Date:  2007-10-29     Completed Date:  2007-12-26     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7805798     Medline TA:  J Toxicol Sci     Country:  Japan    
Other Details:
Languages:  eng     Pagination:  329-41     Citation Subset:  IM    
Affiliation:
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee, Non-clinical Evaluation Subcommittee, Tokyo, Japan. naitousn@otsukakj.co.jp
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MeSH Terms
Descriptor/Qualifier:
Animals
Biomarkers, Pharmacological / metabolism
Consumer Product Safety
Drug Design*
Drug Evaluation / methods*,  trends
Drug Toxicity* / chemically induced,  metabolism
Humans
Pharmaceutical Preparations* / adverse effects,  metabolism
Chemical
Reg. No./Substance:
0/Biomarkers, Pharmacological; 0/Pharmaceutical Preparations

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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