Preclinical evaluation of juvenile toxicity.
A pediatric assessment is now a required component of every New Drug Application in North America or Marketing Authorization Application in Europe, unless a waiver has been granted previously. Nonclinical juvenile toxicity studies are usually required as part of this assessment. The protocols for juvenile toxicity studies are devised in consultation with the FDA or EMEA. It is important to approach the regulatory authority well in advance in order not to delay the marketing authorization of the drug and to confirm the need or not to perform a preclinical evaluation in juvenile animals. The choice of species and the design of juvenile studies are based on a series of complex considerations, including: the therapeutic use of the drug, the age at which children will be treated, the duration of treatment, and potential age- or species-specific differences in pharmacokinetics or toxicity.
Barrow
Paul C
PC
Ricerca Biosciences, Les Oncins, Saint-Germain sur l'Arbresle, France. paul.barrow@mdsinc.com
Barbellion
Stéphane
S
Stadler
Jeanne
J
D000328:Adult; D000375:Aging / Q000502:physiology*; D000818:Animals; D001835:Body Weight / Q000187:drug effects; D002319:Cardiovascular System / Q000187:drug effects; D002648:Child; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D023381:Endpoint Determination; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D033161:Government Regulation; D006801:Humans; D008297:Male; D023421:Models, Animal; D009422:Nervous System Diseases / Q000139:chemically induced; D013045:Species Specificity; D018675:Toxicity Tests / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence