Preclinical safety evaluations supporting pediatric drug development with biopharmaceuticals: Strategy, challenges, current practices

Birth Defects Research Part B - Developmental and Reproductive Toxicology

Volumn 92, Issue 4, 2011, Pages 359-380

  Morford, Laronda L ^a   Bowman, Christopher J ^b   Blanset, Diann L ^c   Bøgh, Ingrid B ^d   Chellman, Gary J ^e   Halpern, Wendy G ^f   Weinbauer, Gerhard F ^g   Coogan, Timothy P ^h  

^a ELI LILLY AND COMPANY   (United States)

^b PFIZER INC   (United States)

^c Charles River Preclinical Services ^*

^d NOVO NORDISK A S   (Denmark)

^e CHARLES RIVER LABORATORIES   (United States)

^f Genentech a Member of the Roche Group   (United States)

^g Developmental and Reproductive Toxicology   (Germany)

^h CENTOCOR INC   (United States)

Author keywords

Biopharmaceuticals; Juvenile; Pediatrics; Postnatal evaluation; Regulatory

Indexed keywords

ANTIBODY; ANTIDRUG ANTIBODY; UNCLASSIFIED DRUG;

ANIMAL BEHAVIOR; ANIMAL EXPERIMENT; BLOOD BRAIN BARRIER; DOG; DRUG DEVELOPMENT; DRUG SAFETY; GENETIC ENGINEERING; HUMAN; IMMUNOTOXICITY; MINIPIG; NONHUMAN; PEDIATRICS; PERINATAL PERIOD; PHARMACEUTICS; PRIORITY JOURNAL; REPRODUCTION; REVIEW;

ANIMALS; ANIMALS, LABORATORY; BIOMEDICAL RESEARCH; CHILD; DRUG DESIGN; DRUG EVALUATION, PRECLINICAL; DRUGS, INVESTIGATIONAL; HEALTH SERVICES NEEDS AND DEMAND; HUMANS; INDUSTRY; MODELS, ANIMAL; PEDIATRICS; TOXICITY TESTS;

EID: 80051945904     PISSN: 15429733     EISSN: 15429741     Source Type: Journal    
DOI: 10.1002/bdrb.20305     Document Type: Review

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