Concepedia

Impurity Threshold Setting

Impurity Threshold Setting is a methodological framework within impurity control strategies that establishes permissible upper limits for contaminants in pharmaceutical substances by integrating risk assessment, analytical detectability, and toxicological significance to ensure product safety and regulatory compliance.

13

Publications

436

Citations

76

Authors

41

Institutions

Publications per year

2017–2026

4

Parents

Publications

13

Impurities in Oligonucleotide Drug Substances and Drug Products

Daniel C. Capaldi, Andy Teasdale, Scott P. Henry et al. · Nucleic Acid Therapeutics · 2017 · 130 citations

, , +15

A quality by design approach to impurity method development for atomoxetine hydrochloride (LY139603)

Peter F. Gavin, Bernard A. Olsen · Journal of Pharmaceutical and Biomedical Analysis · 2007 · 67 citations

, , +14

Potential impurities in drug substances: Compound-specific toxicology limits for 20 synthetic reagents and by-products, and a class-specific toxicology limit for alkyl bromides

Joel P. Bercu, Sheila M. Galloway, Patricia Parris et al. · Regulatory Toxicology and Pharmacology · 2018 · 47 citations

, , +14

Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2: Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscape

Karen M. Alsante, Kim Huynh‐Ba, Steven W. Baertschi et al. · AAPS PharmSciTech · 2013 · 43 citations

, , +17

Regulating impurities in pharmaceutical products: a tolerability of risk approach?

Frédéric Bouder · Expert Review of Clinical Pharmacology · 2008 · 33 citations

, , +17

1–5 of 13

Authors

76

  1. KM
    Karen M. Alsante

    Pfizer (United States), United States

    2 publications · 75 citations

    2

    h-index

  2. MS
    Margaret S. Landis

    Pfizer (United States), United States

    2 publications · 75 citations

    2

    h-index

  3. BA
    Bernard A. Olsen

    Eli Lilly (United States), United States

    2 publications · 110 citations

    2

    h-index

  4. DJ
    David J. Snodin

    PAREXEL International (United Kingdom), United Kingdom

    2 publications · 27 citations

    2

    h-index

  5. KH
    Kim Huynh‐Ba

    Celsion (United States), United States

    2 publications · 75 citations

    2

    h-index

1–5 of 76

Institutions

41

  1. Eli Lilly (United States)

    Indianapolis, United States

    4 h-index

    7 publications

    342 citations

  2. United States Military Academy

    West Point, United States

    3 h-index

    3 publications

    122 citations

  3. Pfizer (United States)

    New York, United States

    3 h-index

    8 publications

    323 citations

  4. Covance (United Kingdom)

    Harrogate, United Kingdom

    2 h-index

    2 publications

    27 citations

  5. PAREXEL International (United Kingdom)

    Birmingham, United Kingdom

    2 h-index

    2 publications

    27 citations

  6. Novartis (Switzerland)

    Basel, Switzerland

    2 h-index

    2 publications

    57 citations

  7. Celsion (United States)

    Lawrenceville, United States

    2 h-index

    2 publications

    75 citations

  8. The Bristol-Myers Squibb Children's Hospital

    New Brunswick, United States

    2 h-index

    2 publications

    79 citations

1–8 of 41

Venues

  1. 2

    h-index

  2. AAPS PharmSciTech

    2 publications · 75 citations

    2

    h-index

  3. Journal of Nuclear Materials

    1 publications · 11 citations

    1

    h-index

  4. 1

    h-index

  5. 1

    h-index

1–5