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Points to Consider in Designing and Conducting Juvenile Toxicology Studies.
Kim, Norman N; Parker, Robert M; Weinbauer, Gerhard F; Remick, Amera K; Steinbach, Thomas.
Afiliación
  • Kim NN; 1 Roivant Sciences, Durham, NC, USA.
  • Parker RM; 2 Envigo, East Millstone, NJ, USA.
  • Weinbauer GF; 3 Covance Preclinical Services, Münster, Germany.
  • Remick AK; 4 Charles River Laboratories, Durham, NC, USA.
  • Steinbach T; 5 EPL, NC, USA.
Int J Toxicol ; 36(4): 325-339, 2017.
Article en En | MEDLINE | ID: mdl-28466670
ABSTRACT
In support of a clinical trial in the pediatric population, available nonclinical and clinical data provide input on the study design and safety monitoring considerations. When the existing data are lacking to support the safety of the planned pediatric clinical trial, a juvenile animal toxicity study is likely required. Usually a single relevant species, preferably a rodent, is chosen as the species of choice, while a nonrodent species can be appropriate when scientifically justified. Juvenile toxicology studies, in general, are complicated both conceptually and logistically. Development in young animals is a continuous process with different organs maturing at different rates and time. Structural and functional maturational differences have been shown to affect drug safety. Key points to consider in conducting a juvenile toxicology study include a comparative development of the organ systems, differences in the pharmacokinetics/absorption, distribution, metabolism, excretion (PK/ADME) profiles of the drug between young animal and child, and logistical requirement in the juvenile study design. The purpose of this publication is to note pertinent points to consider when designing and conducting juvenile toxicology studies and to aid in future modifications and enhancements of these studies to enable a superior predictability of safety of medicines in the pediatric population.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Proyectos de Investigación / Pruebas de Toxicidad / Evaluación Preclínica de Medicamentos / Animales de Laboratorio Tipo de estudio: Guideline / Prognostic_studies Límite: Animals / Humans Idioma: En Revista: Int J Toxicol Asunto de la revista: TOXICOLOGIA Año: 2017 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Proyectos de Investigación / Pruebas de Toxicidad / Evaluación Preclínica de Medicamentos / Animales de Laboratorio Tipo de estudio: Guideline / Prognostic_studies Límite: Animals / Humans Idioma: En Revista: Int J Toxicol Asunto de la revista: TOXICOLOGIA Año: 2017 Tipo del documento: Article País de afiliación: Estados Unidos