Quantitative Extrapolation: An Approach to Validation of Adult Drug Efficacy in Pediatric Subjects-Reference-Cited by-同舟云学术

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Quantitative Extrapolation: An Approach to Validation of Adult Drug Efficacy in Pediatric Subjects

Published:2013-09 Issue:5 Volume:47 Page:557-565
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Leil Tarek A.,Zee Pamela,Suryawanshi Satyendra,Male Christoph,Portman Ronald

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479013500286.pdf

Reference33 articles.

1. Copeland KC, Silverstein J, Moore KR, et al. Management of newly diagnosed type 2 diabetes mellitus (T2DM) in children and adolescents. Pediatrics. 2013;131(2):364–382.

2. Goran MI, Ball GD, Cruz ML. Obesity and risk of type 2 diabetes and cardiovascular disease in children and adolescents. J Clin Endocrinol Metab. 2003;88(4):1417–1427.

3. Krakoff J, Hanson RL, Kobes S, Knowler WC. Comparison of the effect of plasma glucose concentrations on microvascular disease between Pima Indian youths and adults. Diabetes Care. 2001;24(6):1023–1028.

4. Alberti G, Zimmet P, Shaw J, Bloomgarden Z, Kaufman F, Silink M. Type 2 diabetes in the young: the evolving epidemic: the International Diabetes Federation consensus workshop. Diabetes Care. 2004;27(7):1798–1811.

5. Pinhas-Hamiel O, Zeitler P. Clinical presentation and treatment of type 2 diabetes in children. Pediatr Diabetes. 2007;8(suppl 9):16–27.

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2. Use of pharmacodynamic modeling for Bayesian information borrowing in pediatric clinical trials;Journal of Biopharmaceutical Statistics;2022-12-16

3. Pharmacokinetic–Pharmacodynamic Modeling in Pediatric Drug Development, and the Importance of Standardized Scaling of Clearance;Clinical Pharmacokinetics;2018-04-19

4. Approval status and evidence for WHO essential medicines for children in the United States, United Kingdom, and Japan: a cross-sectional study;Journal of Pharmaceutical Policy and Practice;2017-01-06

5. Editor-in-Chief’s Commentary: DIA, TIRS, and ICH;Therapeutic Innovation & Regulatory Science;2014-05

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