Concepedia

Package Insert Approval

Package Insert Approval is a regulatory validation process, within the genus of pharmaceutical documentation oversight, that specifically entails the formal authorization of the informational leaflet accompanying a medicinal product to ensure its content accurately reflects approved indications, safety profiles, and usage guidelines as mandated by health authorities.

7

Publications

158

Citations

11

Authors

5

Institutions

Publications per year

2017–2026

1

Parents

Publications

7

Clinical information in drug package inserts in India

YM Shivkar · Journal of Postgraduate Medicine · 2009 · 46 citations · Full text

, , +11

The New Food and Drug Administration Drug Package Insert: Implications for Patient Safety and Clinical Care

Kelley Teed Watson, Paul G. Barash · Anesthesia & Analgesia · 2008 · 26 citations

, , +12

A Study of Package Inserts in Southern India

JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH · 2013 · 23 citations · Full text

, , +14

Unapproved Uses of Approved Drugs: The Physician, the Package Insert, and the FDA

PEDIATRICS · 1978 · 18 citations

, , +16

An Exploratory Study of Suboxone (Buprenorphine/Naloxone) Film Splitting: Cutting Methods, Content Uniformity, and Stability.

Kristin Reindel, Michael J. DeAngelis, Alexander S. Ferrara et al. · PubMed · 2019 · 18 citations · Full text

, , +11

1–5 of 7

Authors

11

  1. PG
    Paul G. Barash

    Yale University, United States

    1 publications · 26 citations

    1

    h-index

  2. YS
    YM Shivkar

    1 publications · 46 citations

    1

    h-index

  3. KT
    Kelley Teed Watson

    Yale University, United States

    1 publications · 26 citations

    1

    h-index

  4. KM
    Kelly M. Conn

    University of Rochester, United States

    1 publications · 18 citations

    1

    h-index

  5. FZ
    Fang Zhao

    Peking University, China

    1 publications · 18 citations

    1

    h-index

1–5 of 11

Institutions

5

  1. Yale University

    New Haven, United States

    1 h-index

    2 publications

    52 citations

  2. St. John Fisher College

    Rochester, United States

    1 h-index

    7 publications

    126 citations

  3. ESI - Post Graduate Institute of Medical Science and Research

    Bengaluru, India

    1 h-index

    1 publications

    23 citations

  4. Prevent Child Abuse America

    Chicago, United States

    1 h-index

    1 publications

    11 citations

  5. Bangalore Medical College and Research Institute

    Bengaluru, India

    1 h-index

    1 publications

    23 citations

  6. Pharmaceuticals and Medical Devices Agency

    Tokyo, Japan

    1 publications

    16 citations

  7. Teikoku Seiyaku (Japan)

    Higashikagawa, Japan

    1 publications

    16 citations

  8. Yamagata University

    Yamagata, Japan

    1 publications

    16 citations

1–8 of 5

Venues

  1. PubMed

    Repository · 1 publications · 18 citations

    1

    h-index

  2. Journal of Postgraduate Medicine

    1 publications · 46 citations

    1

    h-index

  3. JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH

    1 publications · 23 citations

    1

    h-index

  4. PEDIATRICS

    1 publications · 18 citations

    1

    h-index

  5. European Journal of Anaesthesiology

    EJA · 1 publications · 11 citations

    1

    h-index

1–5