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Measurement uncertainty for the potency estimation by rapid microbiological methods (RMMs) with correlated data
Alessandro Morais Saviano1, Ricardo J N Bettencourt da Silva2, Felipe Rebello Lourenço1
1Departamento de Farmácia, Faculdade de Ciências Farmacêuticas da Universidade de São Paulo, Av. Prof. Lineu Prestes, 580, 05508-000, São Paulo, Brazil.
Regulatory Toxicology and Pharmacology : RTP
|January 18, 2019
Summary
Correlations in data from rapid microbiological methods (RMM) for antibiotic potency testing significantly reduce measurement uncertainty. This finding lowers the risk of incorrect conformity decisions for pharmaceutical products.
Area of Science:
- Microbiology
- Pharmaceutical Analysis
- Analytical Chemistry
Background:
- Rapid microbiological methods (RMM) are increasingly used for antibiotic potency determination.
- Standard uncertainty estimation procedures often neglect data correlation in RMM.
- Ignoring data correlation can impact the reliability of measurement uncertainty and conformity assessments.
Purpose of the Study:
- To investigate the impact of data correlation on measurement uncertainty in RMM.
- To assess the consequences of this correlation on the risk of false conformity decisions.
- To provide a method for estimating uncertainty and conformity risk in RMM.
Main Methods:
- Utilized RMM, specifically an agar diffusion method, for cephalosporin antibiotic potency determination.
- Analyzed shared analytical effects influencing inhibition zone sizes.
- Quantified measurement uncertainty using a multiplicative uncertainty factor (UF) due to lognormal distribution.
Main Results:
- Identified significant data correlation among inhibition zone sizes in RMM.
- Demonstrated that data correlation substantially decreases combined measurement uncertainties.
- Showed a consequent reduction in the risk of false conformity decisions.
Conclusions:
- Accounting for data correlation is crucial for accurate uncertainty estimation in RMM.
- The study provides a framework to mitigate the risk of erroneous conformity assessments in antibiotic potency testing.
- A supplementary Excel tool is available for practical application of these findings.
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