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

Nonfiction, Health & Well Being, Medical, Reference, Drug Guides, Research

• Author: FDA, Biopharma Advantage Consulting L.L.C., eRegs And Guides a Biopharma Advantage Consulting L.L.C.
• ISBN: 1230000220504
• Publisher: Biopharma Advantage Consulting L.L.C.
• Publication: February 22, 2014
• Language: English

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