Juvenile Nonclinical Safety Studies in Support of Pediatric Drug Development-Reference-Cited by-同舟云学术

Juvenile Nonclinical Safety Studies in Support of Pediatric Drug Development

Published:2017 Issue: Volume: Page:25-67
ISSN:1064-3745
Container-title:Methods in Molecular Biology
language:
Short-container-title:

Author:

Barrow Paul C.,Schmitt Georg

Publisher

Springer New York

Link

http://link.springer.com/content/pdf/10.1007/978-1-4939-7172-5_2

Reference98 articles.

1. Mulberg AE, Silber SA, Van den Anker JN (2009) Pediatric drug development: concepts and applications. Wiley, Hoboken, NJ

2. ICH (2009) Guideline M3(R2) on non-clinical safety studies for the conduct of human clinical trials and marketing authorisation for pharmaceuticals. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M3_R2/Step4/M3_R2__Guideline.pdf . Accessed 17 Feb 2016

3. ICH (2000) Harmonised Tripartite Guideline: Clinical investigation of medicinal products in the pediatric population E11. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E11/Step4/E11_Guideline.pdf . Accessed 14 Jan 2016

4. FDA (2006) Guidance for industry: nonclinical safety evaluation of pediatric drug products. FDA, Silver Spring

5. Shirkey H (1968) Editorial comment: therapeutic orphans. J Pediatr 72(1):119–120

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