E12 Clinical Evaluation by Therapeutic Category
E12 Principles for Clinical Evaluation of New Antihypertensive Drugs
This therapeutic area document considers the Clinical Evaluation of New Antihypertensive Drugs. It provides a set of "Principles" on which there is general agreement among all ICH regions covering endpoints and trial designs.
Since there are a few differences in the requirements of the regions that have not been harmonised, this document should be considered an "ICH Principle Document" rather than an "ICH Guideline". It will not be subject to the usual procedures leading to a fully harmonised document.
Other Document (Click the links below for complete guidelines)
*These Guidelines Belongs to ICH website.
ICH E12 Clinical Evaluation by Therapeutic Category Guidelines:
