Concepedia

Package Insert Review

Package Insert Review is a regulatory evaluation process that systematically assesses the proposed content, accuracy, and clarity of a drug's package insert to ensure it provides healthcare professionals with comprehensive, evidence-based information necessary for the safe and effective use of the medication.

12

Publications

318

Citations

23

Authors

8

Institutions

Publications per year

2017–2026

0

Parents

Children

Publications

12

Unapproved Uses of Approved Drugs: The Physician, the Package Insert, and the Food and Drug Administration: Subject Review

PEDIATRICS · 1996 · 88 citations

, , +15

Patient Package Insert Readability and Design

Lisa Ruby Basara, John P. Juergens · American Pharmacy · 1994 · 50 citations

, , +7

An Overview of Transporter Information in Package Inserts of Recently Approved New Molecular Entities

Sheetal Agarwal, Leslie W. Chinn, Lei Zhang · Pharmaceutical Research · 2012 · 25 citations

, , +8

Factors influencing subjects’ comprehension of a set of medicine package inserts

Carla Pires, Marina Vigário, Afonso Cavaco · International Journal of Clinical Pharmacy · 2016 · 21 citations

, , +11

Clinical Pharmacology Information in Summaries of Product Characteristics and Package Inserts

Blanca Arguello, Fernando Fernández-Llimós · Clinical Pharmacology & Therapeutics · 2007 · 21 citations

, , +7

1–5 of 12

Authors

23

  1. CP
    Carla Pires

    University of Lisbon, Portugal

    2 publications · 39 citations

    2

    h-index

  2. AC
    Afonso Cavaco

    University of Lisbon, Portugal

    2 publications · 39 citations

    2

    h-index

  3. LR
    Lisa Ruby Basara

    University of Mississippi, United States

    1 publications · 50 citations

    1

    h-index

  4. RV
    Robert Vander Stichele

    Ghent University, Belgium

    1 publications · 18 citations

    1

    h-index

  5. LZ
    Lei Zhang

    Xiamen University, China

    1 publications · 25 citations

    1

    h-index

1–5 of 23

Institutions

8

  1. University of Lisbon

    Lisbon, Portugal

    3 h-index

    6 publications

    120 citations

  2. Center for Drug Evaluation and Research

    Silver Spring, United States

    1 h-index

    3 publications

    75 citations

  3. United States Food and Drug Administration

    Silver Spring, United States

    1 h-index

    2 publications

    50 citations

  4. Universidad de Granada

    Granada, Spain

    1 h-index

    2 publications

    42 citations

  5. Universität Ulm

    Ulm, Germany

    1 h-index

    4 publications

    48 citations

  6. Ghent University

    Ghent, Belgium

    1 h-index

    4 publications

    72 citations

  7. University of Mississippi

    Oxford, United States

    1 h-index

    2 publications

    100 citations

  8. University of Pittsburgh

    Pittsburgh, United States

    1 h-index

    3 publications

    39 citations

1–8 of 8

Venues

  1. PEDIATRICS

    2 publications · 106 citations

    2

    h-index

  2. PubMed

    Repository · 2 publications · 34 citations

    2

    h-index

  3. Journal of Public Health

    1 publications · 12 citations

    1

    h-index

  4. European Journal of Clinical Pharmacology

    1 publications · 18 citations

    1

    h-index

  5. 1

    h-index

1–5