Good Clinical Practice (GCP) eRegs & Guides - For Your Reference Book 5: ICH - Efficacy Guidelines E3 - E15
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Book Details
Author(s)
Good Clinical Practice eRegs And Guides
Publisher
Biopharma Advantage Consulting L.L.C.
ISBN / ASIN
B008PIHWM8
ISBN-13
978B008PIHWM4
Marketplace
India 🇮🇳
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Description
ICH - Efficacy Guidelines E3 – E15
ICH-E3: Clinical Study Reports ICH-E3 - Structure and Content of Clinical Study Reports
ICH-E4: Dose-Response Information to Support Drug Registration
ICH-E5: Ethnic Factors in the Acceptability of foreign Clinical Data
ICH-E6: Guideline for Good Clinical Practice
ICH-E7: Studies in Support of Special Populations: Geriatrics
ICH-E8: General Considerations for Clinical Trials
ICH-E9: Statistical Principles for Clinical Trials
ICH E-10: Choice of Control Group and Related Issues in Clinical Trials
ICH-E11: Clinical Investigation of Medicinal Products in the Pediatric Population
ICH-E12: Draft ICH Consensus Principle Principles for Clinical Evaluation of New Antihypertensive Drugs
ICH-E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
ICH-E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
ICH-E3: Clinical Study Reports ICH-E3 - Structure and Content of Clinical Study Reports
ICH-E4: Dose-Response Information to Support Drug Registration
ICH-E5: Ethnic Factors in the Acceptability of foreign Clinical Data
ICH-E6: Guideline for Good Clinical Practice
ICH-E7: Studies in Support of Special Populations: Geriatrics
ICH-E8: General Considerations for Clinical Trials
ICH-E9: Statistical Principles for Clinical Trials
ICH E-10: Choice of Control Group and Related Issues in Clinical Trials
ICH-E11: Clinical Investigation of Medicinal Products in the Pediatric Population
ICH-E12: Draft ICH Consensus Principle Principles for Clinical Evaluation of New Antihypertensive Drugs
ICH-E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
ICH-E15: Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories
