Healthy Skepticism Library item: 12286
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: Journal Article
Naito S, Furuta S, Yoshida T, Kitada M, Fueki O, Unno T, Ohno Y, Onodera H, Kawamura N, Kurokawa M, Sagami F, Shinoda K, Nakazawa T, Yamazaki T.
Current opinion: safety evaluation of drug metabolites in development of pharmaceuticals.
J Toxicol Sci 2007 Oct; 32:(4):329-41
http://www.jstage.jst.go.jp/article/jts/32/4/32_329/_article
Abstract:
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.
Keywords:
Animals
Biomarkers, Pharmacological/metabolism
Consumer Product Safety
Drug Design*
Drug Evaluation/methods*
Drug Evaluation/trends
Drug Toxicity*/chemically induced
Drug Toxicity*/metabolism
Humans
Pharmaceutical Preparations*/adverse effects
Pharmaceutical Preparations*/metabolism
