The need for juvenile animal studies - A critical review

Regulatory Toxicology and Pharmacology

Volumn 65, Issue 1, 2013, Pages 87-99

  Soellner, Liane ^a   Olejniczak, Klaus ^b  

^a Bionorica SE ^*  (Germany)

^b Non clinical Regulatory Consultant   (Germany)

Author keywords

Juvenile animal studies; Non clinical safety evaluation; Pediatric drug development; Pediatric investigation plan; Pediatric population; Toxicology

Indexed keywords

ANTIINFECTIVE AGENT; ATOMOXETINE; FLUOXETINE; LISDEXAMFETAMINE; METHYLPHENIDATE;

AGE; ANIMAL EXPERIMENT; ARTICLE; BONE DEVELOPMENT; CLINICAL TRIAL (TOPIC); CONCENTRATION (PARAMETERS); DEVELOPMENTAL TOXICITY; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; HUMAN; JAPAN; JUVENILE ANIMAL; KIDNEY DEVELOPMENT; KINETICS; LAW; NERVOUS SYSTEM DEVELOPMENT; NEUROTOXICITY; NONHUMAN; PEDIATRICS; POSTNATAL DEVELOPMENT; PRIORITY JOURNAL; REPRODUCTIVE TOXICITY; RISK ASSESSMENT; SAFETY; STANDARDIZATION; TOXICITY TESTING; UNITED STATES;

ADULT; AGE FACTORS; ANIMALS; CHILD; DRUG DESIGN; EUROPEAN UNION; HUMANS; LEGISLATION, DRUG; MODELS, ANIMAL; RESEARCH DESIGN; SPECIES SPECIFICITY; TIME FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

ANIMALIA;

EID: 84871451202     PISSN: 02732300     EISSN: 10960295     Source Type: Journal    
DOI: 10.1016/j.yrtph.2012.10.010     Document Type: Article

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