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List of ICH GCP Guidelines - Safety, Efficacy, Quality and Multidisciplinary Topics,
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We have collected the complete List of ICH Guidelines on Efficacy Topics for your reference purpose, under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials.

This Topic Covers,

- Novel types of medicines derived from biotechnological process
- Use of pharmacogenetics/genomics techniques to produce better targeted medicines.

List of ICH Guidelines on Efficacy Topics

E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions

E10 Choice of Control Group and Related Issues in Clinical Trials

E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population

E11A EWG Paediatric Extrapolation

E12 Principles for Clinical Evaluation of New Antihypertensive Drugs

E14 The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs

E14 Q&As (R3) Questions & Answers: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs

E14/S7B IWG Questions & Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential

E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories

E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions

E17 General principles for planning and design of Multi-Regional Clinical Trials

E18 Genomic Sampling and Management of Genomic Data

E19 EWG Optimisation of Safety Data Collection

E20 EWG Adaptive Clinical Trials

E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs)

E2B(R3) EWG/IWG Electronic Transmission of Individual Case Safety Reports (ICSRs)

E2B(R3) Q&As Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports

E2C(R2) Periodic Benefit-Risk Evaluation Report

E2C(R2) Q&As Questions & Answers: Periodic Benefit-Risk Evaluation Report

E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting

E2D(R1) EWG Post Approval Safety Data Management: Definition and Standards for Expedited Reporting

E2E Pharmacovigilance Planning

E2F Development Safety Update Report

E3 Structure and Content of Clinical Study Reports

E3 Q&As (R1) Questions & Answers: Structure and Content of Clinical Study Reports

E4 Dose-Response Information to Support Drug Registration

E5 Q&As (R1) Questions & Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data

E5(R1) Ethnic Factors in the Acceptability of Foreign Clinical Data

E6(R2) Good Clinical Practice (GCP)

E6(R3) EWG Good Clinical Practice (GCP)

E7 Studies in Support of Special Populations: Geriatrics

E7 Q&As Questions & Answers: Studies in Support of Special Populations : Geriatrics

E8 General Considerations for Clinical Trials

E8(R1) EWG Revision on General Considerations for Clinical Studies

E9 Statistical Principles for Clinical Trials

E9(R1) EWG Addendum: Statistical Principles for Clinical Trials


Download all the ICH - Efficacy Guidelines - From Here
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