Concepedia

Regulatory Stability Testing

Regulatory Stability Testing is a formal scientific methodology within pharmaceutical development that systematically evaluates the integrity and degradation profile of drug substances or products under defined environmental stress conditions to comply with regulatory requirements for shelf-life determination, differing from general stability testing by its adherence to strict guidelines established by international health authorities.

41

Publications

1.9K

Citations

265

Authors

83

Institutions

Publications per year

2017–2026

11

Parents

Publications

41

Stability Testing of Pharmaceutical Products

Sanjay Bajaj · Journal of Applied Pharmaceutical Science · 2021 · 245 citations · Full text

, , +16

Stability Testing of Pharmaceutical Products

Yashpal Singh Chauhan, Ravi Nex, Ghanshyam Sevak et al. · Research Journal of Pharmaceutical Dosage Forms and Technology · 2021 · 225 citations

, , +16

Regulatory Aspects of Stability Testing in Europe

Brian R. Matthews · Drug Development and Industrial Pharmacy · 1999 · 198 citations

, , +14

Extension of the International Conference on Harmonization Tripartite Guideline for Stability Testing of New Drug Substances and Products to Countries of Climatic Zones III and IV

W.M. Grimm · Drug Development and Industrial Pharmacy · 1998 · 149 citations

, , +17

The Application of the Accelerated Stability Assessment Program (ASAP) to Quality by Design (QbD) for Drug Product Stability

Kenneth C. Waterman · AAPS PharmSciTech · 2011 · 147 citations · Full text

, , +9

1–5 of 41

Authors

265

  1. SC
    Shein‐Chung Chow

    Duke University, United States

    3 publications · 47 citations

    3

    h-index

  2. RI
    Rafiq Islam

    Pharmaceutical Product Development (United States), United States

    2 publications · 47 citations

    2

    h-index

  3. YL
    Yansheng Liu

    Yale University, United States

    2 publications · 47 citations

    2

    h-index

  4. PC
    Philippe Couerbe

    MPI Research (United States), United States

    2 publications · 47 citations

    2

    h-index

  5. XF
    Xinping Fang

    Pharmaceutical Product Development (United States), United States

    2 publications · 47 citations

    2

    h-index

1–5 of 265

Institutions

83

  1. Covance (United States)

    Princeton, United States

    3 h-index

    7 publications

    134 citations

  2. MPI Research (United States)

    Mattawan, United States

    2 h-index

    4 publications

    94 citations

  3. Energy Research Centre of the Netherlands

    Petten, Netherlands

    2 h-index

    2 publications

    64 citations

  4. Intertek (United States)

    Houston, United States

    2 h-index

    4 publications

    94 citations

  5. Celerion (United States)

    Lincoln, United States

    2 h-index

    4 publications

    94 citations

  6. Pharmaceutical Product Development (United States)

    Wilmington, United States

    2 h-index

    7 publications

    156 citations

  7. AstraZeneca (Sweden)

    Södertälje, Sweden

    2 h-index

    5 publications

    236 citations

  8. PRA Health Sciences

    Raleigh, United States

    2 h-index

    2 publications

    47 citations

1–8 of 83

Venues

  1. PubMed

    Repository · 4 publications · 141 citations

    4

    h-index

  2. Journal of Pharmaceutical Sciences

    3 publications · 41 citations

    3

    h-index

  3. Drug Development and Industrial Pharmacy

    3 publications · 367 citations

    3

    h-index

  4. Bioanalysis

    BIO · 3 publications · 83 citations

    3

    h-index

  5. 2

    h-index

1–5