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 |
Imprint: | Language: | English |
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 |
Imprint: | |
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
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