Search Results - "Chatfield, Marion J."

Method ruggedness studies incorporating a risk based approach: A tutorial by Borman, Phil J., Chatfield, Marion J., Damjanov, Ivana, Jackson, Patrick

“…[Display omitted] ► Design and analysis of method ruggedness studies using a risk based approach. ► Experimental evaluation of noise factors. ► Identification…”
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Design and Analysis of Method Equivalence Studies by Borman, Phil J, Chatfield, Marion J, Damjanov, Ivana, Jackson, Patrick

“…Method equivalence assessments should be considered when analytical methods are either modified or substituted. The TOST (two one sided tests) approach…”
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Avoid the perils of using rounded data by Borman, Phil J., Chatfield, Marion J.

“…Correct use of data for calculations and visualisation. •From a technical point of view it is always better to work with unrounded data.•Implications of using…”
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Acceptance Criteria for Method Equivalency Assessments by Chatfield, Marion J, Borman, Phil J

“…Quality by design (ICH-Topic Q8) requires that process control strategy requirements are met and maintained. The challenging task of setting appropriate…”
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Evaluating change during pharmaceutical product development and manufacture-comparability and equivalence by Chatfield, Marion J., Borman, Phil J., Damjanov, Ivana

“…In the pharmaceutical industry it is necessary to manage changes to processes or analytical methods to ensure that the quality of drug products is maintained…”
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Trace level impurity method development with high-field asymmetric waveform ion mobility spectrometry: systematic study of factors affecting the performance by Champarnaud, Elodie, Laures, Alice M.-F., Borman, Phil J., Chatfield, Marion J., Kapron, James T., Harrison, Mark, Wolff, Jean-Claude

“…For the determination of trace level impurities, analytical chemists are confronted with complex mixtures and difficult separations. New technologies such as…”
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Development, validation and transfer into a factory environment of a liquid chromatography tandem mass spectrometry assay for the highly neurotoxic impurity FMTP (4-(4-fluorophenyl)-1-methyl-1,2,3,6-tetrahydropyridine) in paroxetine active pharmaceutical ingredient (API) by Borman, Phil J., Chatfield, Marion J., Crowley, Elizabeth L., Eckers, Christine, Elder, David P., Francey, Scott W., Laures, Alice M.-F., Wolff, Jean-Claude

“…This work describes the development of a liquid chromatography tandem mass spectrometry (LC–MS/MS) assay for a highly toxic impurity, FMTP…”
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Investigation into the factors affecting accuracy of mass measurements on a time-of-flight mass spectrometer using Design of Experiment by Laures, Alice M.-F., Wolff, Jean-Claude, Eckers, Christine, Borman, Phil J., Chatfield, Marion J.

“…The results of an investigation of the parameters which have the most significant effect on the accuracy of mass measurements on a quadrupole orthogonal…”
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Uncertainty of variance estimators in analytical and process variability studies by Chatfield, Marion J

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Development, validation and transfer into a factory environment of a liquid chromatography tandem mass spectrometry assay for the highly neurotoxic impurity FMTP (4-(4-fluorophenyl)-1-methyl-1.2,3,6-tetrahydropyridine) in paroxetine active pharmaceutical ingredient (API) by BARMAN, Phil J, CHATFIELD, Marion J, CROWLEY, Elizabeth L, ECKERS, Christine, ELDER, David P, FRANCEY, Scott W, LAURES, Alice M.-F, WOLFF, Jean-Claude

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Assessing the Effect of Time in Factorial Designs: The Practical Application by Chatfield, M. J., Owen, M. R.

“…The scientist asks a statistician the question: ‘should we incorporate time as a factor in our factorial designs or measure the response at various…”
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