Search Results - "Borman, Phil"

Regulatory Highlights by Teasdale, Andrew, Borman, Phil J, Mullen, Alexander K

“…In this edition we look at two specific areas. First, we consider the revision of ICH Q2­(R1) and the development of ICH Q14 as they have reached the key ICH…”
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Ongoing Analytical Procedure Performance Verification Using a Risk-Based Approach to Determine Performance Monitoring Requirements by Borman, Phil J., Guiraldelli, Amanda M., Weitzel, Jane, Thompson, Sarah, Ermer, Joachim, Roussel, Jean-Marc, Marach, Jaime, Sproule, Stephanie, Pappa, Horacio N.

“…The analytical procedure life cycle (APLC) provides a holistic framework to ensure analytical procedure fitness for purpose. USP’s general chapter considers…”
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Regulatory Highlights by Teasdale, Andrew, Popkin, Matthew, Ogilvie, Ron, Borman, Phil J, Antonucci, Vincent

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Development and Validation of an In-Line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process by Almeida, Juan, Bezerra, Mariana, Markl, Daniel, Berghaus, Andreas, Borman, Phil, Schlindwein, Walkiria

“…A key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process…”
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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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A risk-based statistical investigation of the quantification of polymorphic purity of a pharmaceutical candidate by solid-state 19F NMR by Barry, Samantha J., Pham, Tran N., Borman, Phil J., Edwards, Andrew J., Watson, Simon A.

“… [Display omitted] ► Investigate a quantitative 19F solid-state NMR method for polymorphic purity. ► DMAIC framework used to investigate risk factors and…”
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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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Selection of Analytical Technology and Development of Analytical Procedures Using the Analytical Target Profile by Borman, Phil, Campa, Cristiana, Delpierre, Ghislain, Hook, Elliot, Jackson, Patrick, Kelley, Wayne, Protz, Michel, Vandeputte, Olivier

“…A structured approach to method development can help to ensure an analytical procedure is robust across the lifecycle of its use. The analytical target profile…”
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Using the Analytical Target Profile to Drive the Analytical Method Lifecycle by Jackson, Patrick, Borman, Phil, Campa, Cristiana, Chatfield, Marion, Godfrey, Mark, Hamilton, Peter, Hoyer, Walter, Norelli, Francesco, Orr, Rachel, Schofield, Tim

“…Quality by design (ICH-Topic Q8) requires a prospective summary of the desired quality characteristics of a drug product. This is known as the Quality Target…”
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Enhanced Approaches to the Identification, Evaluation, and Control of Impurities by Popkin, Matt E., Borman, Phil J., Omer, Batool Ahmed, Looker, Adam, Kallemeyn, Jeffrey M.

“…A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced or quality…”
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Author Correction: Enhanced Approaches to the Identification, Evaluation, and Control of Impurities by Popkin, Matt E., Borman, Phil J., Omer, Batool Ahmed, Looker, Adam, Kallemeyn, Jeffrey M.

“…The original version of this article unfortunately contained a mistake. The authors in the author group were listed incorrectly. The correct author group of…”
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Toward Single-Calibrant Quantification in HPLC. A Comparison of Three Detection Strategies:  Evaporative Light Scattering, Chemiluminescent Nitrogen, and Proton NMR by Lane, Steve, Boughtflower, Bob, Mutton, Ian, Paterson, Clare, Farrant, Duncan, Taylor, Nick, Blaxill, Zoe, Carmody, Carol, Borman, Phil

“…There is an urgent need for detection technologies that enable accurate and precise quantification of solutions containing small organic molecules in a manner…”
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A risk-based statistical investigation of the quantification of polymorphic purity of a pharmaceutical candidate by solid-state super(19F NMR) by Barry, Samantha J, Pham, Tran N, Borman, Phil J, Edwards, Andrew J, Watson, Simon A

“…The DMAIC (Define, Measure, Analyse, Improve and Control) framework and associated statistical tools have been applied to both identify and reduce variability…”
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The Delivery of Flexibility from the Application of QbD to API Development by Popkin, Matt E., Borman, Phil J., Omer, Batool Ahmed, Seibert, Kevin D., Srivastava, Sushil, Lepore, John V., Hobson, Lindsay, Donaubauer, John, Curran, Timothy, Ide, Nathan, Tymonko, Steven, Looker, Adam, Kallemeyn, Jeffrey M.

“…This paper by IQ consortium member companies will describe how the application of the ICH Q11 vision for enhanced QbD development can lead to flexibility…”
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