Pharmacology notes

Apr 15th, 2015
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European Medicines AgencyJune 2000CPMP/ICH/541/00ICH Topic E 12Principles for Clinical Evaluation of New Antihypertensive DrugsStep 5ICH PRINCIPLES DOCUMENT FORCLINICAL EVALUATION OF NEW ANTIHYPERTENSIVE DRUGS(CPMP/ICH/541/00)TRANSMISSION TO CPMPJune 2000TRANSMISSION TO INTERESTED PARTIESJune 2000NOTE This therapeutic area guideline considers the Clinical Evaluation of NewAntihypertensive Drugs. It provides a set of "Principles" on which there is general agreementamong all three ICH regions covering endpoints and trial designs. Since there are a fewdifferences in the requirements of the three regions that have not been harmonised, thisdocument 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 harmonized document.7 Westferry Circus, Canary Wharf, London, E14 4HB, UKTel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40E-mail: mail@emea.eu.int http://www.emea.eu.intEMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA isacknowledgedPRINCIPLES FOR CLINICAL EVALUATION OF NEW ANTIHYPERTENSIVEDRUGSTable of ContentsINTRODUCTION .................................................................................................................... 41.GENERAL PRINCIPLES FOR THE ASSESSMENT OF EFFICACY.................... 42.STUDY POPULATION .........................................

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