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Current Pharmaceutical Analysis

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ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

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Use of Uncertainty Information in Conformity Assessment in the Pharmaceutical Industry

Author(s): Guilherme Lucarelli Orsay, Khrissy Aracélly Reis Medeiros and Elcio Cruz de Oliveira*

Volume 19, Issue 9, 2023

Published on: 25 October, 2023

Page: [673 - 676] Pages: 4

DOI: 10.2174/0115734129262343231020105935

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[1]
Separovic, L.; Lourenço, F.R. Measurement uncertainty and risk of false conformity decision in the performance evaluation of liquid chromatography analytical procedures. J. Pharm. Biomed. Anal., 2019, 171, 73-80.
[http://dx.doi.org/10.1016/j.jpba.2019.04.005] [PMID: 30974411]
[2]
Weißensee, K.; Kühn, O.; Linß, G.; Sommer, K.D. Risk of erroneously deciding conformity of measuring instruments. Accredit. Qual. Assur., 2008, 13(11), 663-669.
[http://dx.doi.org/10.1007/s00769-008-0422-6]
[3]
ILAC. Guidelines on Decision Rules and Statements of Conformity; International Laboratory Accreditation Cooperation: ILAC-G24 OIML D 10, 2019.
[4]
Williams, A.; Magnusson, B. Eurachem/CITAC Guide: Use of uncertainty information in compliance assessment, 2a ed; , 2021.
[5]
Romero, D.C.; Lourenço, F.R. Measurement uncertainty of dissolution test of acetaminophen immediate release tablets using Monte Carlo simulations. Braz. J. Pharm. Sci., 2017, 53(3), 1-9.
[http://dx.doi.org/10.1590/s2175-97902017000300163]
[6]
Traple, M.A.L.; Saviano, A.M.; Francisco, F.L.; Lourenço, F.R. Measurement uncertainty in pharmaceutical analysis and its application. J. Pharm. Anal., 2014, 4(1), 1-5.
[http://dx.doi.org/10.1016/j.jpha.2013.11.001] [PMID: 29403863]
[7]
Separovic, L.; Lourenço, F.R. Measurement uncertainty evaluation of an analytical procedure for determination of terbinafine hydrochloride in creams by HPLC and optimization strategies using Analytical Quality by Design. Microchem. J., 2022, 178, 107386.
[http://dx.doi.org/10.1016/j.microc.2022.107386]
[8]
Separovic, L.; Simabukuro, R.S.; Couto, A.R.; Bertanha, M.L.G.; Dias, F.R.S.; Sano, A.Y.; Caffaro, A.M.; Lourenço, F.R. Measurement uncertainty and conformity assessment applied to drug and medicine analyses – a review. Crit. Rev. Anal. Chem., 2023, 53(1), 123-138.
[http://dx.doi.org/10.1080/10408347.2021.1940086] [PMID: 34152871]
[9]
Separovic, L.; Rebello Lourenço, F. Frequentist approach for estimation of false decision risks in conformity assessment based on measurement uncertainty of liquid chromatography analytical procedures. J. Pharm. Biomed. Anal., 2020, 184, 113203.
[http://dx.doi.org/10.1016/j.jpba.2020.113203] [PMID: 32114160]
[10]
Desimoni, E.; Brunetti, B. Uncertainty of measurement and conformity assessment: a review. Anal. Bioanal. Chem., 2011, 400(6), 1729-1741.
[http://dx.doi.org/10.1007/s00216-011-4776-y] [PMID: 21350814]
[11]
Pendrill, L.R. Optimised measurement uncertainty and decision-making when sampling by variables or by attribute. Measurement, 2006, 39(9), 829-840.
[http://dx.doi.org/10.1016/j.measurement.2006.04.014]
[12]
Evaluation of measurement data: the role of measurement uncertainty in conformity assessment. journal Chemistry International -- Newsmagazine for IUPAC. 2012, 106
[http://dx.doi.org/10.1515/ci.2013.35.2.22]
[13]
Pendrill, L.R. Using measurement uncertainty in decision-making and conformity assessment. Metrologia, 2014, 51(4), S206-S218.
[http://dx.doi.org/10.1088/0026-1394/51/4/S206]
[14]
ASME. B89.7.3.1. Guideline for Decision Rules: Considering Measurement Uncertainty in Determining Confirm to Specifications. 2002, 24
[15]
Dias, F.R.S.; Lourenço, F.R. Measurement uncertainty evaluation and risk of false conformity assessment for microbial enumeration tests. J. Microbiol. Methods, 2021, 189, 106312.
[http://dx.doi.org/10.1016/j.mimet.2021.106312] [PMID: 34428497]
[16]
da Silva, C.M.; Lourenço, F.R. Definition of multivariate acceptance limits (guard-bands) applied to pharmaceutical equivalence assessment. J. Pharm. Biomed. Anal., 2023, 222, 115080.
[http://dx.doi.org/10.1016/j.jpba.2022.115080] [PMID: 36191444]
[17]
Lombardo, M.; da Silva, C.M.; Lourenço, F.R. Conformity assessment of medicines containing antibiotics – A multivariate assessment. Regul. Toxicol. Pharmacol., 2022, 136, 105279.
[http://dx.doi.org/10.1016/j.yrtph.2022.105279] [PMID: 36265715]
[18]
Simabukuro, R.; Jeong, N.A.; Lourenço, F.R. Application of measurement uncertainty on conformity assessment in pharmaceutical drug products. J. AOAC Int., 2021, 104(3), 585-591.
[http://dx.doi.org/10.1093/jaoacint/qsaa151] [PMID: 33156342]
[19]
Burgess, C. Using the guard band to determine a risk-based specification: How to calculate and apply a guard band. Pharm. Technol., 2014, 38, 52-58.

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