Concepedia

Common Technical Document Modules

Common Technical Document Modules is a standardized regulatory framework consisting of five distinct sections that systematically organize the scientific and technical information required for the registration of pharmaceutical products, distinguishing it from other submission formats by its internationally harmonized structure endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

7

Publications

154

Citations

19

Authors

6

Institutions

Publications per year

2017–2026

3

Variants

Ctd Modules

Parents

Publications

7

Challenges for the registration of vaccines in emerging countries: Differences in dossier requirements, application and evaluation processes

Nora Dellepiane, Sonia Pagliusi · Vaccine · 2018 · 39 citations · Full text

, , +16

US FDA Question-Based Review for Generic Drugs: A New Pharmaceutical Quality Assessment System

Lawrence X. Yu, Andre Raw, Robert Lionberger et al. · Journal of Generic Medicines The Business Journal for the Generic Medicines Sector · 2007 · 37 citations

, , +17

An overview of the Common Technical Document (CTD) regulatory dossier

Debbie Jordan · Medical Writing · 2014 · 33 citations

, , +17

Access to medicines for rare diseases: A European regulatory roadmap for academia

Noa Rosenberg, Sibren van den Berg, Nina N. Stolwijk et al. · Frontiers in Pharmacology · 2023 · 12 citations · Full text

, , +17

Abbreviated Clinical Study Reports with Investigational Medicinal Products for Human Use: Current Guidelines and Recommendations

Vicente Alfaro, Martín Cullell-Young, Adnan Tanovı́c · Croatian Medical Journal · 2007 · 12 citations · Full text

, , +16

1–5 of 7

Authors

19

  1. SP
    Sonia Pagliusi

    Developing Countries Vaccine Manufactures Network, Switzerland

    2 publications · 50 citations

    2

    h-index

  2. ND
    Nora Dellepiane

    World Health Organization, Switzerland

    2 publications · 50 citations

    2

    h-index

  3. VA
    Vilayat A. Sayeed

    Center for Drug Evaluation and Research, United States

    1 publications · 37 citations

    1

    h-index

  4. RI
    Robert I. Roth

    University of California, San Francisco, United States

    1 publications · 10 citations

    1

    h-index

  5. MC
    Martín Cullell-Young

    PharmaMar (Spain), Spain

    1 publications · 12 citations

    1

    h-index

1–5 of 19

Institutions

6

  1. Developing Countries Vaccine Manufactures Network

    Nyon, Switzerland

    2 h-index

    2 publications

    50 citations

  2. Food and Drug Administration

    Nonthaburi, Thailand

    1 h-index

    12 publications

    444 citations

  3. University of Jordan

    Amman, Jordan

    1 h-index

    1 publications

    33 citations

  4. Washington University Medical Center

    St Louis, United States

    1 h-index

    1 publications

    10 citations

  5. Universitat de Barcelona

    Barcelona, Spain

    1 h-index

    1 publications

    12 citations

  6. Weinberg Medical Physics (United States)

    Bethesda, United States

    1 h-index

    1 publications

    10 citations

  7. Amsterdam Neuroscience

    Amsterdam, The Netherlands

    1 publications

    12 citations

  8. University of Groningen

    Groningen, The Netherlands

    1 publications

    12 citations

1–8 of 6

Venues

  1. Vaccine

    2 publications · 50 citations

    2

    h-index

  2. 1

    h-index

  3. Drug Information Journal

    DIA · 1 publications · 10 citations

    1

    h-index

  4. Croatian Medical Journal

    CMJ · 1 publications · 12 citations

    1

    h-index

  5. Medical Writing

    1 publications · 33 citations

    1

    h-index

1–5