2. Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations - Guidance for Industry
This guidance is intended to assist sponsors of microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing applications. It discusses how to refine nonclinical study recommendations for this class of drug given its unique characteristics. This guidance also is intended to help sponsors facilitate the timely conduct of clinical trials, reduce the use of animals with the 3R (reduce/refine/replace) principles, and reduce the use of drug development resources
No hay comentarios:
Publicar un comentario