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Application of Measurement Uncertainty on Conformity Assessment in Pharmaceutical Drug Products
16 references·1 citing·36 second hop
Application of Measurement Uncertainty on Conformity Assessment in Pharmaceutical Drug Products (2020)Application of Measurement Uncertainty on…Monte Carlo bottom-up evaluation of global instrumental quantification uncertainty: Flexible and user-friendly computational tool (2020)Monte Carlo bottom-up evaluat…Measurement uncertainty evaluation from correlated validation data: Determination of elemental impurities in pharmaceutical products by ICP-MS (2020)Measurement uncertainty evalu…Standard addition method with cumulative additions: Monte Carlo uncertainty evaluation (2019)Standard addition method with…Risk of false conformity decisions of multicomponent items controlled by correlated measurement results due to the sharing of analytical steps (2018)Risk of false conformity deci…Using measurement uncertainty in decision-making and conformity assessment (2014)Using measurement uncertainty…Quantifying Uncertainty in Analytical Measurement (2012)Quantifying Uncertainty in An…The estimation and use of measurement uncertainty for a drug substance test procedure validated according to USP <1225> (2011)The estimation and use of mea…The effect of calibration equations on the uncertainty of UV–Vis spectrophotometric measurements (2010)The effect of calibration equ…Uncertainty sources in UV-Vis spectrophotometric measurement (2006)Uncertainty sources in UV-Vis…Optimised measurement uncertainty and decision-making when sampling by variables or by attribute (2006)Optimised measurement uncerta…GUIDE TO THE EXPRESSION OF UNCERTAINTY IN MEASUREMENT (2006)GUIDE TO THE EXPRESSION OF UN…A new terminology for the approaches to the quantification of the measurement uncertainty (2006)A new terminology for the app…Traceable property values of in-house reference materials (2002)Traceable property values of …Evaluation of measurement uncertainty for analytical procedures using a linear calibration function (2002)Evaluation of measurement unc…Estimation of uncertainty in routine pH measurement (2002)Estimation of uncertainty in …Tutorial review. Calculating standard deviations and confidence intervals with a universally applicable spreadsheet technique (1994)Tutorial review. Calculating …Risk Assessment in Monitoring of Water Analysis of a Brazilian River (2022)Risk Assessment in Monitoring…Introduction to Statistical Quality Control (1992)What exactly is fitness for purpose in analytical measurement? (1996)Introduction to Statistical Quality Control (1997)Optimised Measurement Uncertainty and Decision-Making in Conformity Assessment (2007)Assessing acceptance sampling application in manufacturing electrical and electronic products (2008)Guidelines to Manage Measurement Uncertainty in Conformance Testing Procedures (2008)Optimizing rating scale category effectiveness. 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Principles of an approach using cause and effect analysis (1998)A review of interference effects and their correction in chemical analysis with special reference to uncertainty (2004)Mass discrimination during MC-ICPMS isotopic ratio measurements: Investigation by means of synthetic isotopic mixtures (IRMM-007 series) and application to the calibration of natural-like zinc materials (including IRMM-3702 and IRMM-651) (2006)Estimation of uncertainty in pK a values determined by potentiometric titration (2004)Evaluation of the residual liquid junction potential contribution to the uncertainty in pH measurement: A case study on low ionic strength natural waters (2010)Seawater pH measurements with a combination glass electrode and high ionic strength TRIS-TRIS HCl reference buffers – An uncertainty evaluation approach (2018)Guidelines and recommended terms for expression of stable‐isotope‐ratio and gas‐ratio measurement results (2011)CODATA recommended values of the fundamental physical constants: 2010 (2012)
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References

  • 2006GUIDE TO THE EXPRESSION OF UNCERTAINTY IN MEASUREMENT6,460 cited
  • 2012Quantifying Uncertainty in Analytical Measurement1,141 cited
  • 1994Tutorial review. Calculating standard deviations and confidence intervals with a universally applicable spreadsheet technique521 cited
  • 2014Using measurement uncertainty in decision-making and conformity assessment140 cited
  • 2006Uncertainty sources in UV-Vis spectrophotometric measurement106 cited
  • 2002Estimation of uncertainty in routine pH measurement53 cited
  • 2006A new terminology for the approaches to the quantification of the measurement uncertainty38 cited
  • 2018Risk of false conformity decisions of multicomponent items controlled by correlated measurement results due to the sharing of analytical steps35 cited
  • 2006Optimised measurement uncertainty and decision-making when sampling by variables or by attribute33 cited
  • 2011The estimation and use of measurement uncertainty for a drug substance test procedure validated according to USP <1225>28 cited
  • 2002Evaluation of measurement uncertainty for analytical procedures using a linear calibration function28 cited
  • 2010The effect of calibration equations on the uncertainty of UV–Vis spectrophotometric measurements27 cited
  • 2020Monte Carlo bottom-up evaluation of global instrumental quantification uncertainty: Flexible and user-friendly computational tool22 cited

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  • 2020Measurement uncertainty evaluation from correlated validation data: Determination of elemental impurities in pharmaceutical products by ICP-MS21 cited
  • 2019Standard addition method with cumulative additions: Monte Carlo uncertainty evaluation20 cited
  • 2002Traceable property values of in-house reference materials20 cited
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    • 2022Risk Assessment in Monitoring of Water Analysis of a Brazilian River11 cited