Scribd Logo
Upload

Welcome to Scribd!

  • 79 views

    Bioanalytical Method Validation - ICH

    Uploaded by

    fdfsdfdssfsfs
    This document proposes a new ICH guideline to harmonize requirements for bioanalytical method validation (BMV) across regions. Currently, guidelines in the EU, US, and Japan differ and require duplicative testing. The proposed guideline would apply to validation of methods used in non-clinical and clinical drug development studies. It would address issues like defining validation characteristics, requirements for reference standards and reagents, study sample analysis, and documentation. Harmonizing BMV requirements would streamline global drug development and remove barriers to mutual acceptance of bioanalytical data internationally. An expert working group would develop recommendations to be adopted on standardized timelines.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Bioanalytical Method Validation - ICH

    Uploaded by

    fdfsdfdssfsfs
    79 views3 pages
    This document proposes a new ICH guideline to harmonize requirements for bioanalytical method validation (BMV) across regions. Currently, guidelines in the EU, US, and Japan differ and require duplicative testing. The proposed guideline would apply to validation of methods used in non-clinical and clinical drug development studies. It would address issues like defining validation characteristics, requirements for reference standards and reagents, study sample analysis, and documentation. Harmonizing BMV requirements would streamline global drug development and remove barriers to mutual acceptance of bioanalytical data internationally. An expert working group would develop recommendations to be adopted on standardized timelines.

    Original Title

    Bioanalytical Method Validation_ICH

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document proposes a new ICH guideline to harmonize requirements for bioanalytical method validation (BMV) across regions. Currently, guidelines in the EU, US, and Japan differ and require duplicative testing. The proposed guideline would apply to validation of methods used in non-clinical and clinical drug development studies. It would address issues like defining validation characteristics, requirements for reference standards and reagents, study sample analysis, and documentation. Harmonizing BMV requirements would streamline global drug development and remove barriers to mutual acceptance of bioanalytical data internationally. An expert working group would develop recommendations to be adopted on standardized timelines.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    79 views3 pages

    Bioanalytical Method Validation - ICH

    Uploaded by

    fdfsdfdssfsfs
    This document proposes a new ICH guideline to harmonize requirements for bioanalytical method validation (BMV) across regions. Currently, guidelines in the EU, US, and Japan differ and require duplicative testing. The proposed guideline would apply to validation of methods used in non-clinical and clinical drug development studies. It would address issues like defining validation characteristics, requirements for reference standards and reagents, study sample analysis, and documentation. Harmonizing BMV requirements would streamline global drug development and remove barriers to mutual acceptance of bioanalytical data internationally. An expert working group would develop recommendations to be adopted on standardized timelines.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 3

    Final endorsed Concept Paper

    M10: Bioanalytical Method Validation


    7 October 2016

    Type of Harmonisation Action Proposed


    The proposed new multidisciplinary guideline will apply to the validation of bioanalytical
    methods and study sample analyses in non-clinical and clinical studies. This guideline will
    provide recommendations on the scientific regulatory requirements for bioanalysis conducted
    during the development of drugs of both chemical and biological origins. This will result in
    the harmonisation of current regional guidelines/guidances and support streamlined global
    drug development.

    Statement of the Perceived Problem


    Bioanalysis herein means the quantification of drugs and their metabolites in biological
    matrices such as plasma, serum, blood, urine or other body fluids, which are conducted in
    non-clinical and clinical studies. Reliable data derived through validated bioanalytical
    methods are key for the review of marketing authorisation application.
    In the EU, US and Japan, regulatory guidelines or draft guidances for bioanalytical method
    validation (BMV) have been issued and recommendations on basic requirements are
    established for these nations/regions. However, several differences in method validation and
    study sample analysis exist among these guidelines/guidances and remain hurdles for the
    mutual use of bioanalytical data in global drug development. This means that sponsors,
    pursuing global approvals, are required to reconcile multiple guidelines/guidances in
    different countries and often requires unnecessary duplicative testing in order to meet the
    variable requirements.
    Current BMV guidelines/guidances:
    EU Guideline on Bioanalytical Method Validation (2011)
    US Guidance for Industry: Bioanalytical Method Validation, DRAFT (2013)
    Guidance for Industry: Bioanalytical Method Validation, (2001)
    Japan Guideline on Bioanalytical Method Validation in Pharmaceutical Development
    (2013)
    Guideline on Bioanalytical Method (Ligand Binding Assay) Validation in
    Pharmaceutical Development (2014)

    Issues to be Resolved
    The main technical and scientific issues in BMV can be categorized as method validation,
    study sample analysis and other issues as described below. The recommendations provided in
    the guideline will address the issues by considering the characteristics of the analytical
    methods used in bioanalysis, e.g., chromatographic assay and ligand binding assay.

    International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

    ICH Secretariat, Chemin des Mines 9, P.O. Box 195, 1211 Geneva 20, Switzerland
    Telephone: +41 (22) 338 32 06 - [email protected], http://www.ich.org
    FINAL M10 Concept Paper Endorsed: 7 October 2016

    1. Method validation

     Define each validation characteristic (e.g., specificity, selectivity, calibration curve,


    sensitivity, reproducibility, accuracy, precision, total error, recovery, range, dilution
    integrity/linearity, matrix effect, carry-over, stability), their appropriate evaluation
    method and acceptance criteria, with respect to methods used to support non-clinical and
    clinical studies
     Clarify the cases where partial or cross validation are necessary and the validation
    characteristics that need to be evaluated
     Establish the requirements for reference standard and critical reagents
     Consolidate scientific experience and progress of instrumentation/technology

    2. Study sample analysis

     Establish the requirements for ensuring the validity of each analytical run (e.g., setting
    the calibration standards and QC samples and their acceptance criteria)
     Clarify the conditions where reanalysis can be done
     Establish the required percentage of samples to be tested for incurred samples reanalysis
    (ISR) and its acceptance criteria

    3. Other issues

     Establish the recommended documentation of validation and study sample analysis


    reports

    This topic is not specifically relevant to any special subpopulation.

    Background to the Proposal


    During the development of chemical and biological drugs, bioanalytical methods are used in
    non-clinical and clinical studies such as pharmacokinetic, toxicokinetic, bioavailability,
    bioequivalence, dose finding and drug-drug interaction studies, etc., in order to describe the
    exposure to the drugs and their metabolites.
    It is important that these bioanalytical methods are well characterised throughout the
    analytical procedures to establish their validity and reliability and ensure reliable review of
    the marketing authorisation application. In order to enable the mutual use of bioanalytical
    data set obtained in each region, international harmonisation of requirements for BMV is
    critical. Without their harmonisation, pharmaceutical companies must validate the
    bioanalytical methods and analyze samples to satisfy the different requirements of the
    guidelines/guidances in each region, thereby causing delay in global drug development and
    adding additional resource and cost burden.
    As a guideline for the validation of analytical procedures, the ICH Q2 Guideline “Validation
    of analytical procedures: text and methodology” was endorsed (Oct. 1994 / Nov. 1996) and
    has been used in the quality evaluation of drug substances and drug products where complex
    matrices are usually not included. In contrast to analyses aimed at drug quality evaluation,
    bioanalysis conducted during non-clinical and clinical studies deals with the analyte in very
    complex biological matrices such as serum, plasma or other body fluids, where variations of
    conditions among individuals can be quite large. Therefore, a guideline specific for
    bioanalytical methods needs to be established separately from ICH Q2. To date, requirements
    for method validation of bioanalysis and study sample analysis have been discussed and

    -2-
    FINAL M10 Concept Paper Endorsed: 7 October 2016

    BMV guidelines/guidances have been issued in each region, although there are some
    differences among them as described above.
    A harmonised BMV guideline will promote the prompt, rational and effective non-clinical
    and clinical studies, thereby advancing the mission of the ICH.

    Type of Expert Working Group Recommended


    The EWG will require experts in bioanalytical methods such as chromatography-based and
    ligand-binding assays to be nominated from the Members and Observers in line with the
    applicable Rules of Procedure.

    Timing

     Adoption of the topic by Approval of ICH Assembly June 2016


     Adoption of Concept Paper and Business Plan by Management Committee Sept. 2016
     First EWG meeting (Osaka, Japan) Nov. 2016
     Adoption of Step2 a/b Document 2Q 2018
     Adoption of Step4 Document 2Q 2019

    -3-

    You might also like