CURRENT OPINION: SAFETY EVALUATION OF DRUG METABOLITES IN DEVELOPMENT OF PHARMACEUTICALS-Reference-Cited by-同舟云学术

CURRENT OPINION: SAFETY EVALUATION OF DRUG METABOLITES IN DEVELOPMENT OF PHARMACEUTICALS

Published:2007 Issue:4 Volume:32 Page:329-341
ISSN:0388-1350
Container-title:The Journal of Toxicological Sciences
language:en
Short-container-title:J. Toxicol. Sci.

Author:

NAITO Shinsaku¹,FURUTA Shigeru¹,YOSHIDA Takemi²,KITADA Mitsukazu³,FUEKI Osamu⁴,UNNO Takashi⁵,OHNO Yasuo⁶,ONODERA Hiroshi⁴,KAWAMURA Nobuyuki⁷,KUROKAWA Misao¹,SAGAMI Fumio¹,SHINODA Kazutoshi⁴,NAKAZAWA Takahiro¹,YAMAZAKI Tsuneyoshi⁸

Affiliation:

1. Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee, Non-clinical Evaluation Subcommittee

2. Showa University, School of Pharmaceutical Sciences

3. Chiba University Hospital

4. Pharmaceuticals and Medical Devices Agency

5. Pharmaceutical Research and Manufactures of America

6. National Institute of Health Sciences

7. European Federation of Pharmaceutical Industries and Associations Japan, Technical Committee

8. Kyoritsu University of Pharmacy

Publisher

Japanese Society of Toxicology

Subject

Toxicology

Link

http://www.jstage.jst.go.jp/article/jts/32/4/32_4_329/_pdf

Reference23 articles.

1. Drug Metabolites in Safety Testing

2. Reply

3. CPMP/EWP/560/95, 17, December (1997): The note of guidance on investigation of drug interactions, Committee for Proprietary Medicinal Products.

4. A Regulatory Perspective on Issues and Approaches in Characterizing Human Metabolites

5. FDA CDER Guidance for Industry, Published in Federal Register, March (2003): Guidance for Industry; Bioavailability and Bioequivalence Studies for Orally Administered Drug Products -General Considerations.

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