Search Results - "Saviano, Alessandro Morais"
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Measurement uncertainty in pharmaceutical analysis and its application
Published in Journal of pharmaceutical analysis (01-02-2014)“…The measurement uncertainty provides complete information about an analytical result. This is very important because several decisions of compliance or…”
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Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)
Published in Brazilian Journal of Pharmaceutical Sciences (01-01-2018)“…According to Quality by Design (QbD) concept, quality should be built into product/method during pharmaceutical/analytical development. Usually, there are many…”
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Determination of cocaine and cocaethylene in urine by solid-phase microextraction and gas chromatography-mass spectrometry
Published in Biomedical chromatography (01-10-2006)“…In order to evaluate recent cocaine exposure or its coingestion with ethanol, a simple and sensitive solid‐phase microextraction (SPME) procedure for…”
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Rapid microbiological methods (RMMs) for evaluating the activity of cephalosporin antibiotics employing triphenyltetrazolium chloride
Published in Talanta (Oxford) (01-08-2018)“…Agar diffusion method has been used to evaluate antimicrobial activity since the discovery of penicillin. Nevertheless, little progress has occurred in…”
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Measurement uncertainty estimation based on multiple regression analysis (MRA) and Monte Carlo (MC) simulations – Application to agar diffusion method
Published in Measurement : journal of the International Measurement Confederation (01-02-2018)“…[Display omitted] •Inhibition zone sizes were expressed as functions of analytical conditions using MRA.•Sources of uncertainty were identified and quantified…”
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Using image analysis to determine gentamicin potency by agar diffusion microbiological assay and its measurement uncertainty
Published in Measurement : journal of the International Measurement Confederation (01-11-2019)“…•Microbiological assay conditions were optimized using design of experiments.•Inhibition zone sizes were measured using ImageJ software for image…”
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Using measurement uncertainty to assess the fitness for purpose of an HPLC analytical method in the pharmaceutical industry
Published in Measurement : journal of the International Measurement Confederation (01-04-2018)“…•The measurement uncertainty of HPLC assay of amoxicillin tablets was estimated.•Assessment of process capability showed manufacturing process under…”
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Rational development and validation of a new microbiological assay for linezolid and its measurement uncertainty
Published in Talanta (Oxford) (01-09-2014)“…The aim of this work was to develop and validate a new microbiological assay to determine potency of linezolid in injectable solution. 24 factorial and central…”
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Measurement uncertainty for the potency estimation by rapid microbiological methods (RMMs) with correlated data
Published in Regulatory toxicology and pharmacology (01-03-2019)“…Recently, rapid microbiological methods (RMM) have often been used to determinate the potency of antibiotic drugs. Since all the standard and sample…”
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Measuring Uncertainty Using Different Approaches: A Case Study for Acetaminophen Quantification
Published in Journal of AOAC International (01-05-2016)“…Investigation of out-of-specification analytical results is laborious, time-consuming, and costly and must be well documented. However, an analytical result is…”
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Kinetic microplate bioassays for relative potency of antibiotics improved by partial Least Square (PLS) regression
Published in Journal of microbiological methods (01-05-2016)“…Microbiological assays are widely used to estimate the relative potencies of antibiotics in order to guarantee the efficacy, safety, and quality of drug…”
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Development, optimization and validation of a rapid colorimetric microplate bioassay for neomycin sulfate in pharmaceutical drug products
Published in Journal of microbiological methods (01-08-2014)“…Microbiological assays have been used to evaluate antimicrobial activity since the discovery of the first antibiotics. Despite their limitations,…”
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13
Uncertainty evaluation for determining linezolid in injectable solution by UV spectrophotometry
Published in Measurement : journal of the International Measurement Confederation (01-12-2013)“…[Display omitted] •We identify several sources of uncertainty in quantification of linezolid.•We evaluate how each uncertainty source contributes to total…”
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Conformity Decisions Based on Measurement Uncertainty—a Case Study Applied to Agar Diffusion Microbiological Assay
Published in Journal of pharmaceutical innovation (01-03-2020)“…Purpose Antimicrobial activity of drug products containing antibiotics is often measured using microbiological assays. However, the high values of measurement…”
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Measurement uncertainty of a UPLC stability indicating method for determination of linezolid in dosage forms
Published in Measurement : journal of the International Measurement Confederation (01-01-2015)“…[Display omitted] •We validated a UPLC method for quantification of linezolid.•We identified several sources of uncertainty in quantification of linezolid.•We…”
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Development, Optimization, and Validation of a Microplate Bioassay for Relative Potency Determination of Linezolid Using a Design Space Concept, and its Measurement Uncertainty
Published in Journal of AOAC International (01-09-2015)“…The aim of this study was to develop, optimize, and validate a microplate bioassay for relative potency determination of linezolid in pharmaceutical samples…”
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Compatibility of Polyvinyl Chloride (PVC) Medical Devices and Other Polymeric Materials with Reactive Ion Etching (RIE) and Inductively Couple Plasma (ICP) Sterilization Using a Quality by Design (QbD) Approach
Published in Journal of pharmaceutical innovation (01-06-2018)“…Purpose The sterilization process for medical devices is an important step due to microbiological quality requirements of polymeric products. Irradiation and…”
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