Concepedia

Modified-release Product Reference Selection

Modified-Release Product Reference Selection is a methodological framework within pharmaceutical regulatory science that determines the appropriate reference listed drug for bioequivalence assessment of modified-release formulations by evaluating pharmacokinetic, pharmacodynamic, and therapeutic equivalence criteria.

3

Publications

195

Citations

30

Authors

18

Institutions

Publications per year

2017–2026

0

Parents

Publications

3

Identification of Phthalates in Medications and Dietary Supplement Formulations in the United States and Canada

Katherine E. Kelley, Sonia Hernández–Dı́az, Erica L. Chaplin et al. · Environmental Health Perspectives · 2011 · 162 citations · Full text

, , +10

Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary Report

Mei-Ling Chen, Vinod P. Shah, Derek Ganes et al. · The AAPS Journal · 2010 · 21 citations · Full text

, , +17

Interchangeability, Safety and Efficacy of Modified-Release Drug Formulations in the USA: The Case of Opioid and Other Nervous System Drugs

Enrique Seoane‐Vazquez, Rosa Rodríguez-Monguió, Richard A. Hansen · Clinical Drug Investigation · 2016 · 12 citations

, , +14

1–3 of 3

Authors

30

  1. RA
    Richard A. Hansen

    University of North Carolina at Chapel Hill, United States

    1 publications · 12 citations

    1

    h-index

  2. SS
    Salomon Stavchansky

    The University of Texas at Austin, United States

    1 publications · 21 citations

    1

    h-index

  3. BA
    Bertil Abrahamsson

    AstraZeneca (Sweden), Sweden

    1 publications · 21 citations

    1

    h-index

  4. RT
    Robert Temple

    United States Food and Drug Administration, United States

    1 publications · 21 citations

    1

    h-index

  5. SH
    Sonia Hernández–Dı́az

    Harvard University, United States

    1 publications · 162 citations

    1

    h-index

1–5 of 30

Institutions

18

  1. International Pharmaceutical Federation

    The Hague, Netherlands

    1 h-index

    2 publications

    42 citations

  2. United States Food and Drug Administration

    Silver Spring, United States

    1 h-index

    9 publications

    189 citations

  3. Clinical Research Institute

    Plymouth, United States

    1 h-index

    1 publications

    21 citations

  4. Harvard University

    Cambridge, United States

    1 h-index

    2 publications

    324 citations

  5. Taro Pharmaceuticals (United States)

    Hawthorne, United States

    1 h-index

    1 publications

    21 citations

  6. Pfizer (United States)

    New York, United States

    1 h-index

    1 publications

    21 citations

  7. Sanofi (France)

    Paris, France

    1 h-index

    1 publications

    21 citations

  8. University of Saskatchewan

    Saskatoon, Canada

    1 h-index

    1 publications

    21 citations

1–8 of 18

Venues

  1. The AAPS Journal

    AAPSJ · 1 publications · 21 citations

    1

    h-index

  2. Environmental Health Perspectives

    EHP · 1 publications · 162 citations

    1

    h-index

  3. Clinical Drug Investigation

    1 publications · 12 citations

    1

    h-index

1–3