Primary analysis and prioritization of risks of biowaiver procedure

Authors

  • Світлана Юріївна Вісич Institute for Advanced Studies of pharmacy professionals NUPh National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002, Ukraine
  • Світлана Володимирівна Русанова Institute of Pharmacy Professionals Qualification Improvement of NUPh National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002, Ukraine
  • Лариса Миколаївна Андрюкова Institute of Pharmacy Professionals Qualification Improvement of NUPh National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002, Ukraine
  • Олександр Вікторович Доровський Institute of Pharmacy Professionals Qualification Improvement of NUPh National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002, Ukraine

DOI:

https://doi.org/10.15587/2519-4852.2016.76466

Keywords:

biowaiver, generic drug, reference drug, risk, risk analysis, prioritization

Abstract

Aim: To conduct cause-effect analysis of identified risks, ranking and prioritization according to general risk assessment methodology to ensure proper execution of biowaiver procedure in compliance with necessary requirements for its reproduction.

Methods: Was used method of cause-effect analysis with construction of Ishikawa diagram. Prioritization of risks was performed with help of expert evaluation.

Results: Performed analysis allowed to identify the most influential risk factors, negative effect of which can cause significant consequences during conduction of bioequivalence studies of generic drug and reference drug based on biowaiver procedure.

Conclusions: Identified and justified priorities among identified risks are carriers of primary causes of potential risk of problem arising in ensuring the quality of conduction of biowaiver procedure. Further studies should be linked to a more profound analysis and risk assessment with regard to their potential threat and probability and formulation of proposals for preventive actions to ensure compliance with established requirements of biowaiver procedure

Author Biographies

Світлана Юріївна Вісич, Institute for Advanced Studies of pharmacy professionals NUPh National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002

Aplicant

Department of Industrial Pharmacy and Economics

Світлана Володимирівна Русанова, Institute of Pharmacy Professionals Qualification Improvement of NUPh National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002

Candidate of Pharmaceutical Sciences, Associate Professor

Department of Industrial Pharmacy and Economics 

Лариса Миколаївна Андрюкова, Institute of Pharmacy Professionals Qualification Improvement of NUPh National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002

Doctor of Pharmaceutical Sciences, Senior Researcher, Associate Professor

Department of Industrial Pharmacy and Economics

Олександр Вікторович Доровський, Institute of Pharmacy Professionals Qualification Improvement of NUPh National University of Pharmacy Pushkinska str., 53, Kharkiv, Ukraine, 61002

Doctor of Economics, professor, Head of Department

Department of Industrial Pharmacy and Economics

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Published

2016-08-31

How to Cite

Вісич, С. Ю., Русанова, С. В., Андрюкова, Л. М., & Доровський, О. В. (2016). Primary analysis and prioritization of risks of biowaiver procedure. ScienceRise: Pharmaceutical Science, (2 (2), 51–57. https://doi.org/10.15587/2519-4852.2016.76466

Issue

No. 2 (2) (2016)

Section

Pharmaceutical Science

License

Copyright (c) 2016 Світлана Юріївна Вісич, Світлана Володимирівна Русанова, Лариса Миколаївна Андрюкова, Олександр Вікторович Доровський

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