Research map: Practical screening and monitoring tools for out-of-specification risk in biological products under finite sample sizes

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Papers in this map

  1. Quantitative Techniques to Evaluate Process Stability · Brett C. Ramirez · 2005 · 27 citations · Cited by this paper
  2. Optimization of a U937 cell-based reporter system to assess ADCC activity of ustekinumab versus trastuzumab · 2026 · Related
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  5. Concept of process capability indices as a tool for process performance measures and its pharmaceutical application · Abikesh Prasada Kumar Mahapatra · 2020 · 19 citations · Cited by this paper
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  7. COMPARING TWO ESTIMATES OF THE VARIANCE TO DETERMINE THE STABILITY OF A PROCESS · Emma N. Cruthis · 1992 · 16 citations · Cited by this paper
  8. Octanoic acid addition: a simple, affordable modification that overcomes lipid removal limitations of traditional antivenom production processes · 2025 · Related
  9. Stability assessment with the stability index · Willis A. Jensen · 2018 · 16 citations · Cited by this paper
  10. A comprehensive review of current diagnostic techniques for Monkeypox virus detection · 2025 · Related
  11. Process monitoring using statistical stability metrics: Applications to biopharmaceutical processes · Keith A. Britt · 2015 · 11 citations · Cited by this paper
  12. Regulatory workshop on standardisation of clinical procedures, endpoints and data robustness of human challenge studies – A stakeholder meeting report · 2025 · Related
  13. Quantitative CPP Evaluation from Risk Assessment Using Integrated Process Modeling · Daniel Borchert · 2019 · 9 citations · Cited by this paper
  14. Functional characterization of the Clostridium perfringens quadruple point mutant epsilon toxin · 2025 · Related
  15. Trending and Out-of-Trend results in pharmaceutical industry · Maja Velinovska Čadinoska · 2019 · 5 citations · Cited by this paper
  16. Integrating 3Rs approaches in WHO guidelines for the batch release testing of biologicals: Summary of NC3Rs final report to WHO Expert Committee for Biological Standardisation · 2024 · Related
  17. Specification-driven acceptance criteria for validation of biopharmaceutical processes · Lukas Marschall · 2022 · 5 citations · Cited by this paper
  18. Report of the Ninth Asian National Control Laboratory Network meeting in 2024, with a focus on regional harmonization of regulatory systems to prepare for cross-border transfer of plasma · 2025 · Related
  19. Digital application for drug product potency target evaluation in biopharmaceutical manufacturing · Darrick Shen · 2024 · 4 citations · Cited by this paper
  20. Diphtheria antitoxin potency assay: an in vitro alternative to the in vivo subcutaneous toxin neutralization test · 2025 · Related
  21. Use of measurement uncertainty in conformity assessment and process capability indices in quality evaluation of pharmaceutical manufacturing processes · Gynna Gómez Barrios · 2025 · 3 citations · Cited by this paper
  22. Predictive Ppk calculations for biologics and vaccines using a Bayesian approach – a tutorial · Jos J. A. M. Weusten · 2024 · 2 citations · Cited by this paper

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