Concepedia

Threshold-based Impurity Assessment

Threshold-Based Impurity Assessment is a methodological framework in pharmaceutical analysis that identifies and quantifies impurities in a substance by applying predetermined threshold limits to distinguish chemically significant degradants or contaminants from negligible species.

17

Publications

505

Citations

73

Authors

25

Institutions

Publications per year

2017–2026

5

Parents

Publications

17

‘Quality by Design’ approach for the analysis of impurities in pharmaceutical drug products and drug substances

Amandine Dispas, H. Avohou, Pierre Lebrun et al. · TrAC Trends in Analytical Chemistry · 2017 · 118 citations

, , +17

Error assessment and optimal cross-validation approaches in machine learning applied to impurity diffusion

Hai-Jin Lu, Nan Zou, Ryan Jacobs et al. · Computational Materials Science · 2019 · 74 citations

, , +12

Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms

Karen M. Alsante, Kim Huynh‐Ba, Steven W. Baertschi et al. · AAPS PharmSciTech · 2013 · 32 citations · Full text

, , +17

Estimation of impurity profiles in drugs and related materials

Sándor Gǒrög, Anna Laukó, Bulcsú Herényi · Journal of Pharmaceutical and Biomedical Analysis · 1988 · 32 citations

, , +13

Estimation of impurity profiles of drugs and related materials

Sándor Gǒrög, Mónika Babják, Gábor Balogh et al. · Journal of Pharmaceutical and Biomedical Analysis · 1998 · 29 citations

, , +12

1–5 of 17

Authors

73

  1. SG
    Sándor Gǒrög

    Gedeon Richter (Hungary), Hungary

    5 publications · 123 citations

    5

    h-index

  2. MB
    Mónika Babják

    Gedeon Richter (Hungary), Hungary

    3 publications · 71 citations

    3

    h-index

  3. JB
    J. BRLIK

    Gedeon Richter (Hungary), Hungary

    3 publications · 73 citations

    3

    h-index

  4. MG
    M. Gazdag

    Gedeon Richter (Hungary), Hungary

    3 publications · 71 citations

    3

    h-index

  5. GB
    Gábor Balogh

    Institute of Biochemistry, Hungary

    2 publications · 47 citations

    2

    h-index

1–5 of 73

Institutions

25

  1. Gedeon Richter (Hungary)

    Budapest, Hungary

    6 h-index

    35 publications

    812 citations

  2. Macao Polytechnic University

    Macao, Macao

    1 h-index

    1 publications

    22 citations

  3. Rutgers, The State University of New Jersey

    New Brunswick, United States

    1 h-index

    1 publications

    32 citations

  4. University of Massachusetts Boston

    Boston, United States

    1 h-index

    3 publications

    63 citations

  5. Dominican University

    River Forest, United States

    1 h-index

    1 publications

    19 citations

  6. Research Triangle Park Foundation

    Durham, United States

    1 h-index

    2 publications

    64 citations

  7. Eli Lilly (United States)

    Indianapolis, United States

    1 h-index

    1 publications

    32 citations

  8. October 6 University

    Giza, Egypt

    1 h-index

    1 publications

    24 citations

1–8 of 25

Venues

  1. 7

    h-index

  2. International Journal of Pharmaceutics

    2 publications · 45 citations

    2

    h-index

  3. 1

    h-index

  4. MOJ Toxicology

    MOJT · 1 publications · 10 citations

    1

    h-index

  5. Acta Informatica

    1 publications · 21 citations

    1

    h-index

1–5