The value of juvenile animal studies What have we learned from preclinical juvenile toxicity studies? II

Birth Defects Research Part B - Developmental and Reproductive Toxicology

Volumn 92, Issue 4, 2011, Pages 273-291

  Bailey, Graham P ^a   Mariën, Dirk ^a  

^a JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

Hazard assessment; Juvenile toxicity survey; Safety assessment; Study design; Survey results

Indexed keywords

ANTIINFECTIVE AGENT; ANTIVIRUS AGENT; CARDIOVASCULAR AGENT; CENTRAL NERVOUS SYSTEM AGENTS; GASTROINTESTINAL AGENT; PROLACTIN;

ADOLESCENT; ANIMAL EXPERIMENT; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; HUMAN; NONHUMAN; PEDIATRICS; PRIORITY JOURNAL; REVIEW; RISK ASSESSMENT; SEXUAL DEVELOPMENT; TOXICOKINETICS; WEANING;

ADULT; ANIMALS; ANIMALS, LABORATORY; CHILD; DOGS; DRUG EVALUATION; DRUGS, INVESTIGATIONAL; HUMANS; MODELS, ANIMAL; PEDIATRICS; RATS; RESEARCH DESIGN; TOXICITY TESTS;

ANIMALIA; CANIS FAMILIARIS; RATTUS;

EID: 80051953044     PISSN: 15429733     EISSN: 15429741     Source Type: Journal    
DOI: 10.1002/bdrb.20328     Document Type: Review

References (7)

1. Bailey GP, Mariën D. 2009. What have we learned from pre-clinical juvenile toxicity studies? Reproductive Toxicology 28:226-229.
2. EMEA. 2008. Guideline on the need for nonclinical testing in juvenile animals on human pharmaceuticals for paediatric indications. European Medicines Agency (EMEA), Committee for Human Medicinal Products (CHMP).
3. FDA. 2006. Guidance document. Nonclinical safety evaluation of paediatric drug products. United States Food and Drug Administration (FDA).
4. Romijn HJ, Hofman MA, Gramsbergen A. 1991. At what age is the developing cerebral cortex of the rat comparable to that of the full-term newborn human baby? Early Hum Dev 26:61-67.
5. De Zwart LL, Scholten M, Monbaliu JG, et al. 2008. The ontogeny of drug metabolizing enzymes and transporters in the rat. Reprod Toxicol 26:220-230.
6. De Zwart LL, Monbaliu JG, Annaert PP. 2008. Absorption, distribution, metabolism and excretion (ADME) and pharmacokinetic assessments in juvenile animals. In: Mulberg AE, Silber S, van den Anker JN, editors. Paediatric drug development: concepts and applications. New York: Wiley.
7. Capon GD, Grantham L, Chmielewski G, Bowman CJ, Hurtt ME. 2011. Power analysis of learning and memory data obtained in a non-human primate ePPND study (unpublished data). Presented at Society of Toxicology Annual Meeting, Washington, DC.