ICH EFFICACY GUIDELINES

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E1: Clinical Safety for Drugs used in Long Term Treatment

E1: The Extent Of Population Exposure To Assess Clinical Safety for Drugs intended for long term treatment of non-life threatening conditions.

E2A-E2F: Pharmacovigilance

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

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

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: Clinical Study Reports

E3: Structure and Content of Clinical Study Reports

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

E4: Dose-Response Studies

E4: Dose-Response Information to Support Drug Registration

E5: Ethnic Factors

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

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

E6: Good Clinical Practice

E6(R2): Good Clinical Practice (GCP)

E6(R3): EWG Good Clinical Practice (GCP)

E7: Clinical Trials in Geriatric Population

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): General Considerations for Clinical Trials

E9: Statistical Principles for Clinical Trials

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

E10: Choice of Control Group in Clinical Trials

E10: Choice of Control Group and Related issues in Clinical Trial

E11-E11A: Clinical Trials in Paediatric Population

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

E11A: EWG Paediatric Extrapolation

E12: Clinical Evaluation by Therapeutic Category

E12: Principles for Clinical Evaluation of New Antihypertensive Drugs

E14: Clinical Evaluation of QT

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 in Pharmacogenetics/Pharmacogenomics

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

E16: Qualification of Genomic Biomarkers

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

E17: Multi-Regional Clinical Trials

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

E18: Genomic Sampling

E18: Genomic Sampling and Management of Genomic Data

E19: Safety Data Collection

E19: A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials

E20: Adaptive Clinical Trials

E20: EWG Adaptive Clinical Trials

E21: Inclusion of Pregnant and Breastfeeding Individuals in Clinical

E21: informal WG Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

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