Concepedia

Nonclinical Module

Nonclinical Module is a systematic component of a Marketing Authorization Application that comprises nonclinical study data and assessments derived from pharmacological, toxicological, and pharmacokinetic investigations, distinguishing it from clinical and quality modules by focusing exclusively on prehuman or nonclinical evidence of a medicinal product’s safety and biological activity.

1

Publications

45

Citations

6

Authors

3

Institutions

Publications per year

2017–2026

1

Variants

Module 4

Parents

Publications

1

1–2 of 1

Authors

6

  1. JY
    Jia Yao

    University of Southern California, United States

    1 publications · 45 citations

    1

    h-index

  2. DL
    Donna L. Mendrick

    National Center for Toxicological Research, United States

    1 publications · 45 citations

    1

    h-index

  3. AM
    Amy M. Avila

    United States Food and Drug Administration, United States

    1 publications · 45 citations

    1

    h-index

  4. PC
    Paul C. Brown

    United States Food and Drug Administration, United States

    1 publications · 45 citations

    1

    h-index

  5. IB
    Ilona Bebenek

    United States Food and Drug Administration, United States

    1 publications · 45 citations

    1

    h-index

1–5 of 6

Institutions

3

  1. National Center for Toxicological Research

    Pine Bluff, United States

    1 h-index

    1 publications

    45 citations

  2. Center for Drug Evaluation and Research

    Silver Spring, United States

    1 h-index

    5 publications

    225 citations

  3. United States Food and Drug Administration

    Silver Spring, United States

    1 h-index

    6 publications

    270 citations

  4. IP Australia

    Canberra, Australia

    1 publications

    11 citations

1–4 of 3

Venues

  1. Regulatory Toxicology and Pharmacology

    RTP · 1 publications · 45 citations

    1

    h-index

1–2