CHILD HEALTH;
DRUG DEVELOPMENT;
DRUG EFFICACY;
DRUG RESEARCH;
DRUG SAFETY;
FOOD AND DRUG ADMINISTRATION;
HUMAN;
JUVENILE ANIMAL;
NONHUMAN;
PRACTICE GUIDELINE;
PRIORITY JOURNAL;
REVIEW;
TOXICITY;
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;
Juvenile toxicity assessment of anidulafungin in rats: an example of navigating case-by-case study design through scientific and regulatory challenges
Bowman CJ, Chmielewski G, Lewis E, et al. 2011. Juvenile toxicity assessment of anidulafungin in rats: an example of navigating case-by-case study design through scientific and regulatory challenges. Birth Defects Res B TBD.
Toxicity study in juvenile rats with the α4β2 nicotinic acetylcholine receptor partial agonist CP-601,927
Campion SN, Hurtt ME, Chatman LA, Cappon GD. 2011. Toxicity study in juvenile rats with the α4β2 nicotinic acetylcholine receptor partial agonist CP-601, 927. Birth Defects Res B.
Juvenile animal toxicity study designs to support pediatric drug development
Cappon GD, Bailey GP, Buschmann J, et al. 2009. Juvenile animal toxicity study designs to support pediatric drug development. Birth Defects Res B Dev Reprod Toxicol 86:463-469.
EMEA. European Medicines Agency (EMEA), Committee for Human Medicinal Products (CHMP). Guideline on the need for nonclinical testing in juvenile animals on human pharmaceuticals for paediatric indications, January 2008.
EMEA. 2008. European Medicines Agency (EMEA), Committee for Human Medicinal Products (CHMP). Guideline on the need for nonclinical testing in juvenile animals on human pharmaceuticals for paediatric indications, January 2008.
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FDA. United States Food and Drug Administration (FDA). Guidance document. Nonclinical safety evaluation of pediatric drug products.
FDA. 2006. United States Food and Drug Administration (FDA). Guidance document. Nonclinical safety evaluation of pediatric drug products.
(2006)
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Juvenile animal studies: testing strategies and design
Hurtt ME, Daston G, Davis-Bruno K, et al. 2004. Juvenile animal studies: testing strategies and design. Birth Defects Res B Dev Reprod Toxicol 71:281-288.
International Conference on Harmonisation; Guideline on detection of toxicity to reproduction for medicinal products
ICH. -
ICH. 1994. International Conference on Harmonisation; Guideline on detection of toxicity to reproduction for medicinal products. Fed Regist 48746-48752.
ICH. Note for guidance on clinical investigation of medicinal products in the paediatric population. Topic e 11 Clinical Investigation of Medicinal Products in the Paediatric Population.
ICH. 2000. Note for guidance on clinical investigation of medicinal products in the paediatric population. Topic e 11 Clinical Investigation of Medicinal Products in the Paediatric Population.
(2000)
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ICH. ICH M3 guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.
ICH. 2009. ICH M3 guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.
(2009)
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Paediatric drug development
Schachter AD, Ramoni MF. 2007. Paediatric drug development. Nat Rev Drug Discov 6:429-430.
Juvenile animal studies for the development of paediatric medicines: a description and conclusions from a European medicines agency workshop on juvenile animal testing for nonclinical assessors
Silva-Lima B, Due Theilade-Thomsen M, Carleer J, et al. 2010. Juvenile animal studies for the development of paediatric medicines: a description and conclusions from a European medicines agency workshop on juvenile animal testing for nonclinical assessors. Birth Defects Res B Dev Reprod Toxicol 89:467-473.
