Concepedia

Risk-based Impurity Management

Risk-Based Impurity Management is a systematic framework within pharmaceutical quality risk management that identifies, assesses, and controls genotoxic impurities according to their potential to pose carcinogenic or mutagenic risks to patients, using scientific principles and regulatory thresholds to prioritize control strategies proportionate to risk.

5

Publications

281

Citations

44

Authors

17

Institutions

Publications per year

2017–2026

2

Parents

Publications

5

The application of structure-based assessment to support safety and chemistry diligence to manage genotoxic impurities in active pharmaceutical ingredients during drug development

Krista L. Dobo, Nigel Greene, Michelle O. Cyr et al. · Regulatory Toxicology and Pharmacology · 2006 · 127 citations

, , +16

Approaches to Assessment, Testing Decisions, and Analytical Determination of Genotoxic Impurities in Drug Substances

Duane A. Pierson, Bernard A. Olsen, David K. Robbins et al. · Organic Process Research & Development · 2008 · 106 citations

, , +16

Safety risk management for low molecular weight process‐related impurities in monoclonal antibody therapeutics: Categorization, risk assessment, testing strategy, and process development with leveraging clearance potential

Haibin Luo, Yuling Li, David J. Robbins et al. · Biotechnology Progress · 2020 · 19 citations · Full text

, , +16

Control of Mutagenic Impurities: Survey of Pharmaceutical Company Practices and a Proposed Framework for Industry Alignment

Christopher J. Borths, Mark D. Argentine, John Donaubauer et al. · Organic Process Research & Development · 2021 · 19 citations

, , +17

Data-Driven Prediction of Risk in Drug Substance Starting Materials

Brandon J. Reizman, Justin L. Burt, Scott A. Frank et al. · Organic Process Research & Development · 2019 · 11 citations

, , +12

1–5 of 5

Authors

44

  1. KL
    Krista L. Dobo

    Pfizer (United States), United States

    1 publications · 127 citations

    1

    h-index

  2. JD
    John Donaubauer

    AbbVie (United States), United States

    1 publications · 19 citations

    1

    h-index

  3. GX
    Guoling Xi

    AstraZeneca (United States), United States

    1 publications · 19 citations

    1

    h-index

  4. MO
    Michelle O. Cyr

    Pfizer (United States), United States

    1 publications · 127 citations

    1

    h-index

  5. JS
    Jeremy Sackett

    Bristol-Myers Squibb (United Kingdom), United Kingdom

    1 publications · 10 citations

    1

    h-index

1–5 of 44

Institutions

17

  1. Eli Lilly (United States)

    Indianapolis, United States

    2 h-index

    8 publications

    587 citations

  2. Pfizer (United States)

    New York, United States

    2 h-index

    7 publications

    673 citations

  3. Bristol-Myers Squibb (United States)

    New York, United States

    2 h-index

    6 publications

    69 citations

  4. AstraZeneca (United States)

    Wilmington, United States

    1 h-index

    10 publications

    190 citations

  5. Bristol-Myers Squibb (Germany)

    Munich, Germany

    1 h-index

    1 publications

    10 citations

  6. GlaxoSmithKline (Sri Lanka)

    Moratuwa, Sri Lanka

    1 h-index

    1 publications

    19 citations

  7. Indiana University South Bend

    South Bend, United States

    1 h-index

    3 publications

    30 citations

  8. Amgen (United States)

    Thousand Oaks, United States

    1 h-index

    1 publications

    19 citations

1–8 of 17

Venues

  1. Organic Process Research & Development

    2 publications · 125 citations

    2

    h-index

  2. Pharmaceutical Research

    1 publications · 10 citations

    1

    h-index

  3. Biotechnology Progress

    1 publications · 19 citations

    1

    h-index

  4. Regulatory Toxicology and Pharmacology

    RTP · 1 publications · 127 citations

    1

    h-index

1–4