Accelerating the Availability of Medications to Pediatric Patients by Optimizing the Use of Extrapolation of Efficacy-Reference-Cited by-同舟云学术

Accelerating the Availability of Medications to Pediatric Patients by Optimizing the Use of Extrapolation of Efficacy

Published:2022-04-26 Issue:6 Volume:56 Page:873-882
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Dunn Allison,Jung Dawoon,Bollinger Lisa L.,Krams Michael,Smith Brian P.,Gobburu Jogarao V. S.^ORCID

Publisher

Springer Science and Business Media LLC

Subject

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

Link

https://link.springer.com/content/pdf/10.1007/s43441-022-00411-2.pdf

Reference51 articles.

1. Ward RM, Benjamin DK, Davis JM, et al. The need for pediatric drug development. J Pediatr. 2018;192:13–21.

2. Burckart GJ, Kim C. The revolution in pediatric drug development and drug use: therapeutic orphans no more. J Pediatr Pharmacol Ther. 2020;25:565–73.

3. 21 CFR 201.57 1979 (USA).

4. 21 CFR 201 1994 (USA)

5. FDA Modernization Act 1997 (USA)

Cited by 6 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Therapeutics Pipeline;Pediatric Clinics of North America;2024-06

2. Suitability of paediatric legislation beyond the USA and Europe: a qualitative study on access to paediatric medicines;BMJ Public Health;2024-02

3. Preface;Essentials of Translational Pediatric Drug Development;2024

4. Off-Label Prescribing in Pediatric Population—Literature Review for 2012–2022;Pharmaceutics;2023-11-21

5. The trajectory of pharmacometrics to support drug licensing and labelling;British Journal of Clinical Pharmacology;2023-04-16