The Effect of Regulation on Pediatric Psoriasis Drug Approvals: The Challenge of the European Union Pediatric Investigation Plans-Reference-Cited by-同舟云学术

The Effect of Regulation on Pediatric Psoriasis Drug Approvals: The Challenge of the European Union Pediatric Investigation Plans

Published:2017-05 Issue:3 Volume:34 Page:e154-e159
ISSN:0736-8046
Container-title:Pediatric Dermatology
language:en
Short-container-title:Pediatr Dermatol

Author:

Rose Klaus¹,Happle Rudolf²

Affiliation:

1. klausrose Consulting; Pediatric Drug Development & More; Riehen Switzerland

2. Department of Dermatology; Freiburg University Medical Center; Freiburg Germany

Publisher

Wiley

Subject

Dermatology,Pediatrics, Perinatology and Child Health

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1111/pde.13097/fullpdf

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3. EU Pediatric Regulation Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for pediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 http://ec.europa.eu/health/files/eudralex/vol-1/reg_2006_1901/reg_2006_1901_en.pdf

4. Ethics and clinical research;Beecher;N Engl J Med,1966

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