A Noninferiority Margin for Acne Lesion Counts

Author:

Gerlinger Christoph,Städtler Gerald,Götzelmann Rolf,Graupe Klaus,Endrikat Jan

Publisher

Springer Science and Business Media LLC

Subject

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

Reference19 articles.

1. James WD. Clinical practice: acne. N Engl J Med. 2005;352:1463–1472.

2. US Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research. Clinical/medical guidance for industry acne vulgaris: developing drugs for treatment. September 2005. Available at: http://www.fda.gov/cder/guidance/6499dft.pdf. accessed January 16. 2007

3. ICH (2000). International Conference on Har-monisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH harmonised tripartite guideline. Choice of control group and related issues in clinical trials. Recommended for adoption at step 4 of the ICH process on July 20, 2000, by the ICH steering committee.

4. Committee for Medicinal Products for Human Use. Guideline on the Choice of the Non-Inferiority Margin. London, July 27, 2005. Doc. Ref. EMEA/CPMP/EWP/2158/99. Available at: http://www.emea.eu.int.pdfs/hurnan/ewp/215899en.pdf, accessed October 31, 2005.

5. Landis JR, Koch GC. The measurement of observer agreement for categorical data. Biometrics, 1977:33(1):159–174.

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