Perspectives on non-clinical safety evaluation of drug metabolites through the JSOT workshop

Journal of Toxicological Sciences

Volumn 37, Issue 4, 2012, Pages 667-673

  Minagawa, Toshiya ^a   Nakano, Kenji ^b   Furuta, Shigeru ^a   Iwasa, Takashi ^a   Takekawa, Koji ^a   Minato, Kouichi ^a   Koga, Toshihisa ^a   Sato, Takashi ^a   Kawashima, Kosuke ^a   Kurahashi, Yoshikazu ^a   Onodera, Hiroshi ^b   Naito, Shinsaku ^a   Nakamura, Kazuichi ^a  

^a Japan Pharmaceutical Manufacturers Association   (Japan)

^b PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

Author keywords

ICH M3(R2); JPMA; Metabolites; MIST; PMDA; Safety assessment

Indexed keywords

DRUG METABOLITE;

ANALYTIC METHOD; CARCINOGENICITY; COMPUTER MODEL; CORRELATION ANALYSIS; DEVELOPMENTAL STAGE; DEVELOPMENTAL TOXICITY; DRUG ANALYSIS; DRUG DEVELOPMENT; DRUG EXPOSURE; DRUG INDUSTRY; GENOTOXICITY; HEALTH SURVEY; HUMAN; IN VITRO STUDY; ISOTOPE LABELING; MASS SPECTROMETRY; METABOLITE; NONHUMAN; NUCLEAR MAGNETIC RESONANCE; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); REVIEW; RISK ASSESSMENT; SYMPOSIUM; WORKSHOP;

EID: 84865615064     PISSN: 03881350     EISSN: 18803989     Source Type: Journal    
DOI: 10.2131/jts.37.667     Document Type: Review

References (28)

1. Baillie, T.A., Cayen, M.N., Fouda, H., Gerson, R.J., Green, J.D., Grossman, S.J., Klunk, L.J., LeBlanc, B., Perkins, D.G. and Shipley, L.A. (2002): Drug metabolites in safety testing. Toxicol. Appl. Pharmacol., 182, 188-196.
2. Baillie, T.A., Cayen, M.N., Fouda, H., Gerson, R.J., Green, J.D., Grossman, S.J., Klunk, L.J., LeBlanc, B., Perkins, D.G. and Shipley, L.A. (2003): Reply. Toxicol. Appl. Pharmacol., 190, 93-94.
3. Cheung, B.W.Y., Cartier, L.L., Russlie, H.Q. and Sawchuk, R.J. (2005): The application of sample pooling methods for determining AUC, AUMC and mean residence times in pharmacokinetic studies. Fundam. Clin. Pharmacol., 19, 347-54.
4. EMA/CHMP/SWP/431994/2007 Rev. 3, September (2010): Questions and answers on the 'Guideline on the limits of genotoxic impurities'.
5. FDA CDER Guidance for Industry, Published in Federal Register, May (2001): Bioanalytical Method Validation.
6. FDA CDER Guidance for Industry, Published in Federal Register, February (2008): Safety Testing of Drug Metabolites.
7. FDA CDER Guidance for Industry, Published in Federal Register, December (2008): Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches (Draft).
8. Furuta, S., Kawashima, K., Takekawa, K., Iwasa, T., Minagawa, T., Minato, K., Miura, S., Koga, T., Sato, T., Naito, S. and Nakamura, K. (2011): Non-clinical safety evaluation of drug metabolites: Efforts toward the drug discovery and development. P.M.R.J. 42, 902-909.
9. Hastings, K.L., El-Hage, J., Jacobs, A., Leighton, J., Morse, D. and Osterberg, R.E. (2003): Letter to the editor. Toxicol. Appl. Pharmacol., 190, 91-92.
10. ICH M3 (R2) Guideline Questions & Answers, June (2011).
11. Kawashima, K. (2010): Non-clinical safety evaluation of drug metabolites-Efforts toward the drug discovery and development. Abstracts of the 37th annual meeting of the Japanese Society of Toxicology, pp.30.
12. Klopman, G. (1984): Artificial intelligence approach to structureactivity studies. Computer automated structure evaluation of biological activity of organic molecules. J. Am. Chem. Soc., 106, 7315-7321.
13. Leclercq, L., Cuyckens, F., Mannens, G.S.J., de Vries, R., Timmerman, P. and Evans, D.C. (2009): Which human metabolites have we MIST? Retrospective analysis, practical aspects, and perspectives for metabolite identification and quantification in pharmaceutical development. Chem. Res. Toxicol., 22, 280-293.
14. MHLW, Yakushin no. 526, March (1975): Points to Consider for Approval Application Data for New Manufacture or Import Drugs.
15. MHLW, Iyakushin no. 1834, December (2000): Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility (ICH S5(R2)).
16. MHLW, Iyakushin no. 902, June (2001): Safety Pharmacology Studies for Human Pharmaceuticals (ICH S7A).
17. MHLW, Iyakushin no. 1216001, December (2002): Impurities in New Drug Substances (ICH Q3A(R2)).
18. MHLW, Iyakushin no. 0624001, June (2003): Impurities in New Drug Products (ICH Q3B(R2)).
19. MHLW, Yakushokushin no. 1023-4, October (2009): The Non- Clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals (ICH S7B).
20. MHLW, Yakushokushin no. 0219-4, February (2011): Guidance on Non-clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3(R2)).
21. Minagawa, T., Kawashima, K., Takekawa, K., Minato, K., Iwasa, T., Furuta, S., Naito, S. and Nakamura, K. (2010): A questionnaire survey on non-clinical safety evaluation of drug metabolites. The JSSX 25th Annual Meeting Abstracts 302.
22. 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. and Yamazaki, T. (2007): Current opinion: safety evaluation of drug metabolites in development of pharmaceuticals. J. Toxicol. Sci., 32, 329-341.
23. Nakano, K. (2010): Preclinical safety evaluation of drug metabolites: Current opinion of Japanese regulatory. Abstracts of the 37th annual meeting of the Japanese Society of Toxicology, pp.32.
24. Ohno, Y. (1992): Toxicity testing: Regulatory perspectives. Proceedings of the First International Conference on Harmoniza-tion. 1991 Nov.; Brussels, Belgium. Ed D'Arcy PFD and Harron DWG. The Queen's University of Belfast. 186-188.
25. Olson, H., Betton, G., Robinson, D., Thomas, K., Monro, A., Kolaja, G., Lilly, P., Sanders, J., Sipes, G., Bracken, W., Dorato, M., Van Deun, K., Smith, P., Berger, B. and Heller, A. (2000): Concordance of the toxicity of pharmaceuticals in humans and in animals, Regul. Toxicol. Pharmacol., 32, 56-67.
26. Sanderson, D.M. and Earnshaw, C.G. (1991): Computer prediction of possible toxic action from chemical structure; the DEREK system. Hum. Exp. Toxicol., 10, 261-273.
27. Timmerman, P. (2009): The European Bioanalysis Forum, towards European pharma companies best practice on metabolite quantification, AAPS, Los Angeles -Nov. 12.
28. Yu, C., Chen, C.L., Gorycki, F.L. and Neiss, T.G. (2007): A rapid method for quantitatively estimating metabolites in human plasma in the absence of synthetic standards using a combination of liquid chromatography/mass spectrometry and radiometric detection. Rapid. Commun. Mass Spectrom., 21, 497-502.