Good Clinical Practice (GCP) eRegs & Guides - For Your Reference Book 5

Good Clinical Practice For Your Reference - Book 5 

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