Statistics and Statisticians in European Drug Regulatory Agencies

Author:

Köpcke Wolfgang,Jones David R.,Huitfeldt Bernhard,Schmidt Karsten

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Drug Guides,Pharmacology (nursing)

Reference7 articles.

1. Royal Statistical Society Working Party on Statistics in Drug Regulation. Statistics and statisticians in drug regulation in the United Kingdom. J Roy Stat Soc A. 1992;154:413–419.

2. Lewis JA. Editorial: Statistics and statisticians in the Regulation of Medicines. J Roy Stat Soc A. 1996; 159: 359–362.

3. Griffin JP, Charlesworth FA. European procedures for obtaining marketing authorizations for human medicines after 1992-−EC commission proposals. Int Pharmacy J. 1990;4:246–251.

4. Committee on Proprietary Medicinal Products Working Party on Efficacy of Medicinal Products. Note for Guidance III/3630/92-EN: Biostatistical Methodology in Clinical Trials in Applications for Marketing Authorizations for Medicinal Products. Brussels: European Commission; 1994.

5. D’Arcy PF, Harron DWG, eds. Proceedings of the 1st International Conference on Harmonization. Belfast: Queen’s University; 1992.

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