An FDA oncology view of juvenile animal studies in support of initial pediatric trials for anticancer drugs
Author:
Publisher
Elsevier BV
Subject
Toxicology,General Medicine
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3. The evolution of juvenile animal testing for small and large molecules;Baldrick;Regul. Toxicol. Pharmacol.,2013
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1. An FDA Oncology Perspective of Juvenile Toxicity Studies to Support Pediatric Drug Development;Pediatric Cancer Therapeutics Development;2022
2. Navigating the Regulatory Landscape to Develop Pediatric Oncology Drugs: Expert Opinion Recommendations;Pediatric Drugs;2021-06-26
3. Juvenile Animal Testing: Assessing Need and Use in the Drug Product Label;Therapeutic Innovation & Regulatory Science;2018-09
4. Lack of value of juvenile animal toxicity studies for supporting the safety of pediatric oncology phase I trials;Regulatory Toxicology and Pharmacology;2018-07
5. Bridging Adult Experience to Pediatrics in Oncology Drug Development;The Journal of Clinical Pharmacology;2017-09-15
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