Ì points to considerî regarding safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies (English translation)

Journal of Toxicological Sciences

Volumn 29, Issue 5, 2004, Pages 497-504

  Nakazawa, Takahiro ^a   Kai, Shuichi ^a   Kawai, Mutsufumi ^a   Maki, Eiji ^a   Sagami, Fumio ^a   Onodera, Hiroshi ^b   Kitajima, Satoshi ^c   Inoue, Tohru ^c  

^a Japan Pharmaceut Manufacturers A   (Japan)

^b PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

^c NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

Author keywords

Biotechnology derived pharmaceuticals; English translation; ICH S6 guideline; Non clinical; Points to consider

Indexed keywords

UNCLASSIFIED DRUG; BIOLOGICAL PRODUCT;

BIOTECHNOLOGY; DRUG INDUSTRY; HUMAN; JAPAN; LANGUAGE; PRACTICE GUIDELINE; PUBLICATION; REVIEW; SAFETY; TEAMWORK; ANIMAL; ARTICLE; DOSE RESPONSE; DRUG SCREENING; INTERNATIONAL COOPERATION; LEGAL ASPECT; METHODOLOGY; STANDARD; TOXICITY TESTING;

ANIMALS; BIOLOGICAL PRODUCTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG EVALUATION, PRECLINICAL; DRUG INDUSTRY; GUIDELINES; HUMANS; INTERNATIONAL COOPERATION; JAPAN; TOXICITY TESTS;

EID: 12444298008     PISSN: 03881350     EISSN: 18803989     Source Type: Journal    
DOI: 10.2131/jts.29.497     Document Type: Review

References (4)

1. CPMP/372/01 (2001): Points to consider on the non-clinical assessment of the carcinogenic potential of insulin analogues. www.emea.eu.int.
2. CPMP/SWP/2600/01 (2002): Points to consider on the need for assessment of reproduction toxicity of human insulin analogues. www.emea.eu.int.
3. Ministry of Health and Welfare (2000): Preclinical safety evaluation of biotechnology-derived pharmaceuticals. Notification No. 326.
4. Pharmaceutical Non-clinical Investigation Group (2002): "Points to consider" regarding safety assessment of biotechnology-derived pharmaceuticals in non-clinical studies. In Handbook on non-clinical guidelines for pharmaceuticals 2002, pp.83-94, Yakujinipposya, Tokyo.