Esta tradução está a ser preparada. Entretanto, mostramos temporariamente a versão original em inglês.
Negócios · 15/02/20061 min de leitura
Guidance for Industry on Nonclinical Safety Evaluation of Pediatric Drug Products; Availability
Tradução automática local · Idioma original da fonte
Resumo
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Nonclinical Safety Evaluation of Pediatric Drug Products." This document provides guidance on the role and timing of animal studies in the nonclinical safety evaluation of therapeutics intended for the treatment of pediatric patients. The guidance discusses some conditions under which juvenile animals can be meaningful predictors of toxicity in pediatric patients and makes recommendations on nonclinical testing.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →