Changes in Drug Development Regulations and Their Impact on Clinical Trials
Author:
Publisher
Springer International Publishing
Link
https://link.springer.com/content/pdf/10.1007/978-3-319-31420-4_38-2
Reference50 articles.
1. American Academy of Pediatrics. Committee on Drugs (1977) Guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations. Pediatrics 60:91–101
2. Batisky DL, Sorof JM, Sugg J et al (2007) Efficacy and safety of extended release metoprolol succinate in hypertensive children 6 to 16 years of age: a clinical trial experience. J Pediatr 150:134–139, 139 e1
3. Benjamin DK Jr, Smith PB, Murphy MD et al (2006) Peer-reviewed publication of clinical trials completed for pediatric exclusivity. JAMA 296:1266–1273
4. Benjamin DK Jr, Smith PB, Jadhav P et al (2008) Pediatric antihypertensive trial failures: analysis of end points and dose range. Hypertension 51:834–840
5. Best Pharmaceuticals for Children Act (2002) Full text of Best Pharmaceuticals for Children Act. Accessed at: https://www.congress.gov/107/plaws/publ109/PLAW-107publ109.pdf. April 23, 2021
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