Scribd Logo
Upload

Welcome to Scribd!

  • The ICH Guidelines

    Uploaded by

    Vamsi Krishna Matcha
    520 views2 pages
    The document outlines the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. These guidelines cover quality, safety, and efficacy topics for drug development and are divided into the following categories: quality, safety, efficacy, and multidisciplinary. The quality guidelines cover topics like stability, analytical validation, and impurities. The safety guidelines cover preclinical testing topics like carcinogenicity and genotoxicity studies. The efficacy guidelines cover clinical studies topics like exposure assessment, dose response, and special populations. The multidisciplinary guidelines cover areas like medical terminology and electronic standards.

    Original Description:

    Copyright

    © Attribution Non-Commercial (BY-NC)

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    The document outlines the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. These guidelines cover quality, safety, and efficacy topics for drug development and are divided into the following categories: quality, safety, efficacy, and multidisciplinary. The quality guidelines cover topics like stability, analytical validation, and impurities. The safety guidelines cover preclinical testing topics like carcinogenicity and genotoxicity studies. The efficacy guidelines cover clinical studies topics like exposure assessment, dose response, and special populations. The multidisciplinary guidelines cover areas like medical terminology and electronic standards.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    520 views2 pages

    The ICH Guidelines

    Uploaded by

    Vamsi Krishna Matcha
    The document outlines the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. These guidelines cover quality, safety, and efficacy topics for drug development and are divided into the following categories: quality, safety, efficacy, and multidisciplinary. The quality guidelines cover topics like stability, analytical validation, and impurities. The safety guidelines cover preclinical testing topics like carcinogenicity and genotoxicity studies. The efficacy guidelines cover clinical studies topics like exposure assessment, dose response, and special populations. The multidisciplinary guidelines cover areas like medical terminology and electronic standards.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 2

    The ICH Guidelines - QSEM

    Quality (Q) - chemical & pharmaceutical QA

    Safety (S) -dealing with in vitro & in vivo pre clinical testing

    Efficacy (E) -clinical studies in human beings

    Multidisciplinary (M) -Terminology ,Electronic Standards ,Common Documents

    Quality Guidelines

    Q 1: Stability - Photostability

    Q 2: Analytical Validation

    Q 3: Impurities

    Q 5: Biotechnological Quality

    Q 6: Specifications

    Q 7: GMP for active pharma ingredients

    Q 8: Pharmaceutical development

    Q 9: Quality risk management

    Safety guidelines

    • S1: Carcinogenicity studies – Need, Testing, Dose Selection

    • S2: Genotoxicity – Regulatory, Battery of Tests


    -- Converted from Word to PDF for free by Fast PDF -- www.fastpdf.com --

    • S3A: Toxicokinetics

    • S3B: Pharmacokinetics

    • S4: Chronic Toxicity Testing

    • S5A: Toxicity to Reproduction

    • S5B: Toxicity to Male Fertility

    • S6: Preclinical Biotech derived drugs

    • S7A: Safety Pharmacology

    • S7B: QT interval prolongation

    • S8: Immunotoxicity
    Efficacy Guidelines

    E 1: Exposure – to assess clinical safety

    E 2: Clinical Safety Data Management

    (E2A, E2B, E2C)

    E 3: Study Reports

    E 4: Dose Response Studies

    E 5: Ethnic Factors

    E 6: Good Clinical Practice (GCP)

    E 7: Special Populations - Geriatrics

    E 8: Clinical Trials Design

    E 9: Statistical Considerations

    E 10: Choice of Control Group

    E 11: Special Populations – Children

    E 12: Therapeutic categories

    (E 12A)

    - E 14: The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non
    -- Converted from Word to PDF for free by Fast PDF -- www.fastpdf.com --

    antiarrhythmic drugs

    Multidisciplinary (M)

    M1: Medical Terminology

    M2: Electronic Standards for Transfer of Regulatory Information & Data(ESTRI)

    M3: Maintenance of ICH guidelines for nonclinical safety studies

    M4: Common Technical Document (CTD)

    M4Q: Quality

    M4S: Safety

    M4E: Efficacy

    You might also like