The value of juvenile animal studies: A Japanese industry perspective

Birth Defects Research Part B - Developmental and Reproductive Toxicology

Volumn 92, Issue 4, 2011, Pages 266-268

  Shimomura, Kazuhiro ^a  

^a DAIICHI SANKYO CO   (Japan)

Author keywords

Japan; Juvenile study; Perspective

Indexed keywords

ADOLESCENT; ANIMAL EXPERIMENT; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; JAPAN; JUVENILE ANIMAL; NONHUMAN; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUESTIONNAIRE; REVIEW; TOXICITY; TOXICOKINETICS;

ADULT; ANIMALS; ANIMALS, LABORATORY; BIOMEDICAL RESEARCH; CHILD; DRUG DESIGN; DRUG EVALUATION, PRECLINICAL; DRUGS, INVESTIGATIONAL; GROWTH AND DEVELOPMENT; GUIDELINES AS TOPIC; HUMANS; MODELS, ANIMAL; PEDIATRICS; TOXICITY TESTS;

ANIMALIA;

EID: 80051940479     PISSN: 15429733     EISSN: 15429741     Source Type: Journal    
DOI: 10.1002/bdrb.20300     Document Type: Review

References (7)

1. Dodo T, Shimomura K, Horimoto M, et al. 2008. Non-clinical juvenile animal studies for pediatric drugs (2)-questionnaire survey. Pharm Regul Sci 39:134-141.
2. EMEA. 2008. European Medicines Agency (EMEA), Committee for Human Medicinal Products (CHMP). Guideline on the need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications. January 2008.
3. FDA. 2006. United States Food and Drug Administration (FDA). Guidance document. Nonclinical safety evaluation of pediatric drug products. Silver Spring, MD: FDA.
4. Horimoto M, Koike K, Nawa T, et al. 2008. Non-clinical juvenile animal studies for pediatric drugs (3)-current perspectives of the authorities on this topic from the FDA guidance and EMEA draft guideline. Pharm Regul Sci 39:142-167.
5. ICH. 2000. E11 Guideline; Clinical Investigation of Medical Products in the Pediatric Population. Geneva: ICH.
6. ICH. 2009. M3 Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. Geneva: ICH.
7. Nagayama T, Baba N, Goto H, et al. 2008. Non-clinical juvenile animal studies for pediatric drugs (1)-investigation of NDA documents and assessment reports in Japan. Pharm Regul Sci 39:127-133.