International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States-Reference-Cited by-同舟云学术

International Coherence of Pediatric Drug Labeling for Drug Safety: Comparison of Approved Labels in Korea and the United States

Published:2019-11-10 Issue:3 Volume:107 Page:530-540
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Song Yun‐Kyoung¹,Han Nayoung²,Burckart Gilbert J.³,Oh Jung Mi²

Affiliation:

1. College of Pharmacy Daegu Catholic University Gyeongsan‐si Gyeongbuk Korea

2. College of Pharmacy Research Institute of Pharmaceutical Sciences Seoul National University Gwanak‐gu Seoul Korea

3. Office of Clinical Pharmacology Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1640

Reference48 articles.

1. A Patient-Centered Prescription Drug Label to Promote Appropriate Medication Use and Adherence

2. European Medicines Agency.Paediatric medicine: overview. Accessed January 11 2019.

3. US Food and Drug Administration.Pediatric product development. Accessed January 11 2019.

4. Impact of Pediatric Exclusivity on Drug Labeling and Demonstrations of Efficacy

5. European Medicines Agency.Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use (2006). Accessed June 1 2019.

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