Juvenile animal toxicity study designs to support pediatric drug development.
The objective of juvenile animal toxicity studies of pharmaceuticals is to obtain safety data, including information on the potential for adverse effects on postnatal growth and development. Studies in juvenile animals may assist in identifying postnatal developmental toxicities or other adverse effects that are not adequately assessed in the routine toxicity evaluations and that cannot be safely or adequately measured in pediatric clinical trials. Unlike the traditional reproductive and developmental toxicology studies that have been discussed in the accompanying reports, the design requirements for toxicity studies in juvenile animals are not explicitly defined in regulatory guidance. However, studies in juvenile animals can be useful in providing safety information necessary to enable pediatric clinical trials in pediatric patients or when there are special concerns for toxicities that cannot be safely or adequately measured in clinical trials. These juvenile animal toxicity studies are designed on a case-by-case basis. General design considerations and examples of study designs for assessment of juvenile animal toxicity are discussed.
Cappon
Gregg D
GD
Pfizer Global Research and Development, Groton Laboratories, Connecticut 06340, USA. Gregg.d.cappon@pfizer.com
Bailey
Graham P
GP
Buschmann
Jochen
J
Feuston
Maureen H
MH
Fisher
J Edward
JE
Hew
Kok Wah
KW
Hoberman
Alan M
AM
Ooshima
Yojiro
Y
Stump
Donald G
DG
Hurtt
Mark E
ME
D000818:Animals; D000830:Animals, Laboratory; D000831:Animals, Newborn; D004353:Drug Evaluation, Preclinical / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D048788:Growth and Development / Q000187:drug effects*; D008297:Male; D010372:Pediatrics; D004364:Pharmaceutical Preparations / Q000145:classification; D051381:Rats; D011919:Rats, Inbred Strains; D012107:Research Design; D018675:Toxicity Tests / Q000379:methods*
D004364:Pharmaceutical Preparations