Guideline Comments

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Listed on this page are all commentaries and abstracts on guidelines collected until now. If you would like to write an abstract for a guideline or comment a guideline, please use the Abstract Form

Comment on Guideline ICH-E4 Step 5: Dose-Response Information to Support Drug Registration
Authors of Comment: Heuer, C., Dunger-Baldauf, C., Prinz, H.
22 Januar 1997

Abstract for Guideline ICH-E2B Step 3: Clinical safety data management: data elements for transmission of individual case safety reports
Authors of Abstract: Harnischmacher, U., Wadepuhl, M., Heinecke, A.
28 Februar 1997

Comment on Guideline CPMP/EWP/238/95: Guidelines for the clinical investigation of medicinal products in the treatment of hypertension
Authors of Comment: Nicolay, C., Haag, U., Herbold, M.
15 March 1997

Comment on Guideline CPMP/EWP/560/95: Guidelines for the clinical investigation of medicinal products in the treatment of hypertension
Author of Comment: Nicolay, C.
1 March 1998

Comment on Guidance for Industry: Computerized Systems Used in Clinical Trials
Author of Comment: Harnischmacher, U.
16 March 1998

Comment on Guideline ICH-E9 Step 5:  Statistical Principles for Clinical Trials
Authors of  Comment: Dietlein, G., Dunger-Baldauf, C., Herbold, M., Lomp, H.-J., Wadepuhl, M.
March 1999


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Please e-mail errors or changes to Urs Harnischmacher

27 Apr 1999