Juvenile animal toxicity study designs to support pediatric drug development

Birth Defects Research Part B - Developmental and Reproductive Toxicology

Volumn 86, Issue 6, 2009, Pages 463-469

  Cappon, Gregg D ^a   Bailey, Graham P ^b   Buschmann, Jochen ^c   Feuston, Maureen H ^d   Fisher, J Edward ^e   Hew, Kok Wah ^f   Hoberman, Alan M ^g   Ooshima, Yojiro ^h   Stump, Donald G ⁱ   Hurtt, Mark E ^a  

^a PFIZER INC   (United States)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^c FRAUNHOFER INSTITUTE FOR TOXICOLOGY AND EXPERIMENTAL MEDICINE   (Germany)

^d US Inc   (United States)

^e CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^f TAKEDA PHARMACEUTICALS   (United States)

^g CHARLES RIVER LABORATORIES   (United States)

^h SHIN NIPPON BIOMEDICAL LABORATORIES LTD   (Japan)

ⁱ WIL RESEARCH LABORATORIES   (United States)

Author keywords

Juvenile toxicity; Pharmaceuticals; Regulatory; Safety assessment

Indexed keywords

ANTIBIOTIC AGENT;

DRUG DEVELOPMENT; HUMAN; LIVER TOXICITY; NEUROTOXICITY; NONHUMAN; POSTNATAL DEVELOPMENT; POSTNATAL GROWTH; PRENATAL DEVELOPMENT; PRIORITY JOURNAL; REPRODUCTIVE TOXICITY; REVIEW; SCREENING; TOXICOLOGY;

ANIMALS; ANIMALS, LABORATORY; ANIMALS, NEWBORN; DRUG EVALUATION, PRECLINICAL; DRUG TOXICITY; FEMALE; GROWTH AND DEVELOPMENT; MALE; PEDIATRICS; PHARMACEUTICAL PREPARATIONS; RATS; RATS, INBRED STRAINS; RESEARCH DESIGN; TOXICITY TESTS;

ANIMALIA;

EID: 73649089618     PISSN: 15429733     EISSN: None     Source Type: Journal    
DOI: 10.1002/bdrb.20220     Document Type: Review

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