Good Clinical Practice 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