Concepedia

Nonclinical Data Package

A Nonclinical Data Package is a comprehensive compilation of preclinical pharmacological and toxicological study data, generated through in vitro and in vivo investigations, that characterizes the safety, biological activity, and physicochemical properties of an investigational drug to support its initial evaluation in humans under an Investigational New Drug Application.

11

Publications

998

Citations

64

Authors

32

Institutions

Publications per year

2017–2026

5

Variants

Preclinical Data Package

Parents

Publications

11

THE CONDUCT OF IN VITRO AND IN VIVO DRUG-DRUG INTERACTION STUDIES: A PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA (PhRMA) PERSPECTIVE

Thorir D. Bjornsson, John T. Callaghan, Heidi J. Einolf et al. · Drug Metabolism and Disposition · 2003 · 784 citations

, , +17

An industry perspective on the FDA Modernization Act 2.0/3.0: potential next steps for sponsors to reduce animal use in drug development

Sarah A. Carratt, Christina L Zuch de Zafra, Elias M. Oziolor et al. · Toxicological Sciences · 2024 · 48 citations · Full text

, , +16

Gaps and challenges in nonclinical assessments of pharmaceuticals: An FDA/CDER perspective on considerations for development of new approach methodologies

Amy M. Avila, Ilona Bebenek, Donna L. Mendrick et al. · Regulatory Toxicology and Pharmacology · 2023 · 45 citations

, , +11

An FDA perspective on the nonclinical use of the X-Omics technologies and the safety of new drugs

Abigail Jacobs · Toxicology Letters · 2008 · 28 citations

, , +17

An assessment of the carcinogenic potential of ezetimibe using nonclinical data in a weight-of-evidence approach

Margaretann M. Halleck, Harry R. Davis, Paul T. Kirschmeier et al. · Toxicology · 2009 · 28 citations

, , +15

1–5 of 11

Authors

64

  1. VF
    Volker Fischer

    Novartis (United States), United States

    1 publications · 784 citations

    1

    h-index

  2. CL
    Christina L Zuch de Zafra

    Pfizer (United States), United States

    1 publications · 48 citations

    1

    h-index

  3. JS
    J. S. Macdonald

    Royal Marsden Hospital, United Kingdom

    1 publications · 28 citations

    1

    h-index

  4. SA
    Susan A. Griffiths

    MRC Toxicology Unit, United Kingdom

    1 publications · 13 citations

    1

    h-index

  5. TD
    Thorir D. Bjornsson

    Duke Medical Center, United States

    1 publications · 784 citations

    1

    h-index

1–5 of 64

Institutions

32

  1. United States Food and Drug Administration

    Silver Spring, United States

    4 h-index

    10 publications

    331 citations

  2. Pfizer (United States)

    New York, United States

    2 h-index

    10 publications

    2.7K citations

  3. Center for Drug Evaluation and Research

    Silver Spring, United States

    2 h-index

    7 publications

    247 citations

  4. Women's Health Research Institute

    Vancouver, Canada

    1 h-index

    1 publications

    784 citations

  5. The Bristol-Myers Squibb Children's Hospital

    New Brunswick, United States

    1 h-index

    2 publications

    22 citations

  6. Eli Lilly (United States)

    Indianapolis, United States

    1 h-index

    2 publications

    22 citations

  7. Experimental Pathology Laboratories

    Sterling, United States

    1 h-index

    1 publications

    11 citations

  8. Covance (United States)

    Princeton, United States

    1 h-index

    1 publications

    10 citations

1–8 of 32

Venues

  1. Regulatory Toxicology and Pharmacology

    RTP · 3 publications · 66 citations

    3

    h-index

  2. Human & Experimental Toxicology

    2 publications · 23 citations

    2

    h-index

  3. Toxicological Sciences

    1 publications · 48 citations

    1

    h-index

  4. Toxicologic Pathology

    1 publications · 11 citations

    1

    h-index

  5. Toxicology

    1 publications · 28 citations

    1

    h-index

1–5