Current opinion: safety evaluation of drug metabolites in development of pharmaceuticals.
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.
Naito
Shinsaku
S
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee, Non-clinical Evaluation Subcommittee, Tokyo, Japan. naitousn@otsukakj.co.jp
Furuta
Shigeru
S
Yoshida
Takemi
T
Kitada
Mitsukazu
M
Fueki
Osamu
O
Unno
Takashi
T
Ohno
Yasuo
Y
Onodera
Hiroshi
H
Kawamura
Nobuyuki
N
Kurokawa
Misao
M
Sagami
Fumio
F
Shinoda
Kazutoshi
K
Nakazawa
Takahiro
T
Yamazaki
Tsuneyoshi
T
D000818:Animals; D054316:Biomarkers, Pharmacological / Q000378:metabolism; D003257:Consumer Product Safety; D015195:Drug Design; D004341:Drug Evaluation / Q000379:methods* / Q000639:trends; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced / Q000378:metabolism; D006801:Humans; D004364:Pharmaceutical Preparations / Q000378:metabolism
D054316:Biomarkers, Pharmacological; D004364:Pharmaceutical Preparations