Search Results - "Debie, Elke"

A Confidence Level Algorithm for the Determination of Absolute Configuration Using Vibrational Circular Dichroism or Raman Optical Activity by Debie, Elke, De Gussem, Ewoud, Dukor, Rina K., Herrebout, Wouter, Nafie, Laurence A., Bultinck, Patrick

“…Spectral comparison is an important part of the assignment of the absolute configuration (AC) by vibrational circular dichroism (VCD), or equally by Raman…”
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Utilization of risk-based predictive stability within regulatory submissions; industry’s experience by McMahon, Megan, Williams, Helen, Debie, Elke, Fu, Mingkun, Bujalski, Robert, Qiu, Fenghe, Wu, Yan, Li, Hanlin, Wang, Jin, Hoaglund-Hyzer, Cherokee, Pulliam, Donnie

“…Risk-Based Predictive Stability (RBPS) tools, such as the Accelerated Stability Assessment Program (ASAP) and other models, are used routinely within…”
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Solvent effects on IR and VCD spectra of natural products: an experimental and theoretical VCD study of pulegone by Debie, Elke, Bultinck, Patrick, Herrebout, Wouter, van der Veken, Benjamin

“…The VCD spectra of pulegone, dissolved in CDCl3, CD2Cl2 and CS2 have been recorded in the frequency range from 1000 to 3000 cm(-1). The assignment of the…”
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Science- and Risk-Based Stability Strategies to Support Product Lifecycle Changes by McCaig, Lori, Nowak, Steven, Abbott, Alexander, Carhart, Jenny, McMahon, Megan E., Debie, Elke, Li, Hanlin, Maina, Francis, Ji, Andrea J., Fu, Mingkun, Wu, Yan, Lennard, Andrew, Mazzeo, Tony, Wolfe, Chad, Timpano, Robert, Babayan, Yelizaveta, Gruenig, Lars

“…ICH Q12 asserts that science- and risk-based approaches are applicable to stability studies supporting Chemistry, Manufacturing and Controls (CMC)…”
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Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies by McMahon, Megan E., Abbott, Alexander, Babayan, Yelizaveta, Carhart, Jenny, Chen, Chi-wan, Debie, Elke, Fu, Mingkun, Hoaglund-Hyzer, Cherokee, Lennard, Andrew, Li, Hanlin, Mazzeo, Tony, McCaig, Lori, Pischel, Sylvine, Qiu, Fenghe, Stephens, Dennis, Timpano, Robert, Webb, Debra, Wolfe, Chad, Woodlief, Kayla, Wu, Yan

“…In consideration of the recent ICH Quality Discussion Group (QDG) recommended revision to the ICH series of stability guidelines, the IQ Consortium…”
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Correction to: Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies by McMahon, Megan E., Abbott, Alexander, Babayan, Yelizaveta, Carhart, Jenny, Chen, Chi-wan, Debie, Elke, Fu, Mingkun, Hoaglund-Hyzer, Cherokee, Lennard, Andrew, Li, Hanlin, Mazzeo, Tony, McCaig, Lori, Pischel, Sylvine, Qiu, Fenghe, Stephens, Dennis, Timpano, Robert, Webb, Debra, Wolfe, Chad, Woodlief, Kayla, Wu, Yan

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Induced solvent chirality: A VCD study of camphor in CDCl3 by Debie, Elke, Jaspers, Lize, Bultinck, Patrick, Herrebout, Wouter, Veken, Benjamin Van Der

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A VCD robust mode analysis of induced chirality: The case of pulegone in chloroform by Nicu, Valentin Paul, Debie, Elke, Herrebout, Wouter, Van der Veken, Benjamin, Bultinck, Patrick, Baerends, Evert Jan

“…Vibrational modes in an achiral molecule may acquire rotational strength by complexation to a chiral molecule, as happens for achiral solvent molecules…”
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Induced solvent chirality: A VCD study of camphor in CDCl 3 by Debie, Elke, Jaspers, Lize, Bultinck, Patrick, Herrebout, Wouter, Veken, Benjamin Van Der

“…Using Vibrational Circular Dichroism on camphor dissolved in CDCl 3, it is found that the C–D stretch becomes VCD active. It is shown how the presence of a…”
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Vibrational circular dichroism DFT study on bicyclo[3.3.0]octane derivatives by Debie, Elke, Kuppens, Tom, Vandyck, Koen, Van der Eycken, Johan, Van Der Veken, Benjamin, Herrebout, Wouter, Bultinck, Patrick

“…The absolute configurations of four bicylco[3.3.0]octane derivatives: endo-bicyclo[3.3.0]octane-2,6-diol, endo-2,6-diacetoxybicyclo[3.3.0]octane,…”
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Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory Template by Stephens, Dennis, Williams, Helen, McMahon, Megan, Qiu, Fenghe, Hyzer, Cherokee Hoaglund, Debie, Elke, Wu, Yan, Li, Hanlin, Wang, Jin

“…The resulting open-dish data were fit to a humidity-corrected Arrhenius equation using ASAPprime Version 5.0 [a lternative commercial or inhouse software may…”
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Risk-Based Predictive Stability for Pharmaceutical Development-A Proposed Regulatory Template: A published regulatory template sharing best practices for filing RBPS data would benefit the industry and regulatory reviewers by enabling a consistent presentation of predictive data and conclusions by Stephens, Dennis, Williams, Helen, McMahon, Megan, Qiu, Fenghe, Hyzer, Cherokee Hoaglund, Debie, Elke, Wu, Yan, Li, Hanlin, Wang, Jin

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Risk-Based Predictive Stability-An Industry Perspective by Williams, Helen, Stephens, Dennis, McMahon, Megan, Debie, Elke, Qiu, Fenghe, Hyzer, Cherokee Hoaglund, Sechler, Lois, Orr, Rachel, Webb, Debra, Wu, Yan, Hahn, David

“…The survey responses indicated that while RBPS studies have primarily been used for formulation screening and shelf-life predictions/ use period assignment,…”
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Risk-based predictive stability--an industry perspective: a survey on risk-based predictive stability tools reveals how pharma companies are leveraging advanced stability approaches throughout the drug development process by Williams, Helen, Stephens, Dennis, McMahon, Megan, Debie, Elke, Qiu, Fenghe, Hyzer, Cherokee Hoaglund, Sechler, Lois, Orr, Rachel, Webb, Debra, Wu, Yan, Hahn, David

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