Concepedia

Method Validation Documentation

Method Validation Documentation is a formal record within regulatory documentation for bioequivalence that belongs to the class of scientific validation artifacts, specifically comprising evidence and rationale demonstrating that an analytical method meets predefined acceptance criteria for its intended use in assessing the equivalence of pharmaceutical products.

30

Publications

3.4K

Citations

108

Authors

50

Institutions

Publications per year

2017–2026

6

Parents

Publications

30

GlobCover - Products Description and Validation Report

P. Bicheron, Defourny Pierre, Carsten Brockmann et al. · Joint Research Centre (European Commission) · 2008 · 649 citations

, , +10

Official and tentative methods

T. H. Hopper · Journal of the American Oil Chemists Society · 1951 · 496 citations

, , +4

European Medicines Agency Guideline on Bioanalytical Method Validation: What More Is There to Say?

G. T. Smith · Bioanalysis · 2012 · 307 citations

, , +14

Analysis of recent pharmaceutical regulatory documents on analytical method validation

Eric Rozet, Attilio Ceccato, Cédric Hubert et al. · Journal of Chromatography A · 2007 · 268 citations

, , +10

Validation in pharmaceutical analysis. Part I: An integrated approach

Joachim Ermer · Journal of Pharmaceutical and Biomedical Analysis · 2001 · 254 citations

, , +14

1–5 of 30

Authors

108

  1. ER
    Eric Rozet

    University of Liège, Belgium

    2 publications · 412 citations

    2

    h-index

  2. BB
    Bruno Boulanger

    University of Liège, Belgium

    2 publications · 412 citations

    2

    h-index

  3. GT
    G. T. Smith

    Commonwealth Scientific and Industrial Research Organisation, Australia

    2 publications · 363 citations

    2

    h-index

  4. SM
    Stuart McDougall

    Covance (United Kingdom), United Kingdom

    1 publications · 42 citations

    1

    h-index

  5. HM
    Herold Martin

    UCLouvain, Belgium

    1 publications · 649 citations

    1

    h-index

1–5 of 108

Institutions

50

  1. Sanofi (France)

    Paris, France

    2 h-index

    2 publications

    398 citations

  2. University of Liège

    Liège, Belgium

    2 h-index

    6 publications

    1.4K citations

  3. UCB Pharma (Belgium)

    Brussels, Belgium

    2 h-index

    2 publications

    186 citations

  4. Laboratoires Expanscience

    Courbevoie, France

    1 h-index

    1 publications

    144 citations

  5. Merck Serono S.A.S. (France)

    Lyon, France

    1 h-index

    1 publications

    144 citations

  6. GlaxoSmithKline (United Kingdom)

    London, United Kingdom

    1 h-index

    1 publications

    42 citations

  7. Gedeon Richter (Hungary)

    Budapest, Hungary

    1 h-index

    2 publications

    190 citations

  8. Nnamdi Azikiwe University

    Awka, Nigeria

    1 h-index

    1 publications

    15 citations

1–8 of 50

Venues

  1. 4

    h-index

  2. Bioanalysis

    BIO · 3 publications · 405 citations

    3

    h-index

  3. Journal of Chromatography A

    2 publications · 282 citations

    2

    h-index

  4. Joint Research Centre (European Commission)

    Repository · 2 publications · 673 citations

    2

    h-index

  5. ALTEX

    2 publications · 53 citations

    2

    h-index

1–5