The Role of Health-Related Quality of Life Data in the Drug Approval Processes in the US and Europe-Reference-Cited by-同舟云学术

The Role of Health-Related Quality of Life Data in the Drug Approval Processes in the US and Europe

Published:2011-06 Issue:3 Volume:25 Page:147-160
ISSN:1178-2595
Container-title:Pharmaceutical Medicine
language:en
Short-container-title:Pharm Med

Author:

Marquis Patrick,Caron Martine,Emery Marie-Pierre,Scott Jane A.,Arnould Benoit,Acquadro Catherine

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Link

http://link.springer.com/content/pdf/10.1007/BF03256856.pdf

Reference70 articles.

1. Willke RJ, Burke LB, Erickson P. Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels. Control Clin Trials 2004; 25: 535–52

2. Apolone G, De Carli G, Brunetti M, et al. Health-related quality of life (HR-QOL) and regulatory issues: an assessment of theEuropeanAgency for the Evaluation of Medicinal Products (EMEA) recommendations on the use of HR-QOL measures in drug approval. Pharmacoeconomics 2001; 19: 187–95

3. Papanicolaou S, Sykes D, Mossialos E. EMEA and the evaluation of healthrelated quality of life data in the drug regulatory process. Int J Technol Assess Health Care 2004; 20: 311–24

4. Szende A, Leidy NK, Revicki D. Health-related quality of life and other patient-reported outcomes in the European centralized drug regulatory process: a review of guidance documents and performed authorizations of medicinal products 1995 to 2003. Value Health 2005; 8: 534–48

5. US Department of Health and Human Services, Food and Drug Administration. Patient-reported outcome measures: use in medical product development to support labeling claims. Fed Regist 2006; 71 (23): 5862–3

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