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

Good Clinical Practice eRegs & Guides - For Your Reference Book

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Good Clinical Practice eRegs & Guides provides a
reference to key US FDA Guides and regulations via your electronic reader. An
excellent way to access the reference documents on your e-reader. No need to
carry paper books and you can search for key terms. 




In this issue you will find: 


 



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



 



 

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Publisher
eregs & guides
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Pages
204
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Language
English
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Genres
Business & Economics / Industries / Pharmaceutical & Biotechnology
Fiction / Medical
Medical / General
Science / Biotechnology
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