Utilization of risk-based predictive stability within regulatory submissions; industry’s experience

Autor: Cherokee Hoaglund-Hyzer, Mingkun Fu, Robert Bujalski, Helen E. Williams, Elke Debie, Jin Wang, Hanlin Li, Fenghe Qiu, Megan McMahon, Donnie Pulliam, Yan Wu

Publikováno v: AAPS Open, Vol 6, Iss 1, Pp 1-11 (2020)

Risk-Based Predictive Stability (RBPS) tools, such as the Accelerated Stability Assessment Program (ASAP) and other models, are used routinely within pharmaceutical development to quickly assess stability characteristics, especially to understand mec

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::807fe112a8b9ce9b751cce02bb55b50a
http://link.springer.com/article/10.1186/s41120-020-00034-7

Considerations for Updates to ICH Q1 and Q5C Stability Guidelines: Embracing Current Technology and Risk Assessment Strategies

Autor: Cherokee Hoaglund-Hyzer, Mingkun Fu, Alexander Abbott, Megan McMahon, Sylvine Pischel, Lori McCaig, Chi-wan Chen, Jenny Carhart, Kayla Woodlief, Andrew Lennard, Dennis Stephens, Yan Wu, Debra Webb, Fenghe Qiu, Robert J. Timpano, Hanlin Li, Tony Mazzeo, Elke Debie, Yelizaveta Babayan, Chad Nolan Wolfe

Publikováno v: The AAPS Journal. 23

In consideration of the recent ICH Quality Discussion Group (QDG) recommended revision to the ICH series of stability guidelines, the IQ Consortium (International Consortium for Innovation and Quality in Pharmaceutical Development) Science- and Risk-

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::731bc556aaab25ec8ed805c05e69f648
https://doi.org/10.1208/s12248-021-00641-6

A VCD robust mode analysis of induced chirality: The case of pulegone in chloroform

Autor: Benjamin J. van der Veken, Valentin Paul Nicu, Wouter A. Herrebout, Evert Jan Baerends, Patrick Bultinck, Elke Debie

Publikováno v: Chirality: the pharmaceutical, biological, and chemical consequences of molecular asymmetry
CHIRALITY
Chirality, E287-E297. Wiley
ISSUE=21;STARTPAGE=E287;ENDPAGE=E297;ISSN=0899-0042;TITLE=Chirality
Nicu, V P, Debie, E, Herrebouts, W, van der Veken, B, Bultinck, P & Baerends, E J 2010, ' A VCD robust mode analysis of induced chirality: the case of pulegone in chloroform ', Chirality, no. 21, pp. E287-E297 . https://doi.org/10.1002/chir.20817

Vibrational modes in an achiral molecule may acquire rotational strength by complexation to a chiral molecule, as happens for achiral solvent molecules complexed to a chiral solute. We investigate this transfer of chirality in vibrational circular di

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9e2e3beb70ef04a8b73fbe4e57f87e48
https://doi.org/10.1002/chir.20817

Induced solvent chirality: A VCD study of camphor in CDCl3

Autor: Benjamin J. van der Veken, Patrick Bultinck, Wouter A. Herrebout, Lize Jaspers, Elke Debie

Publikováno v: Chemical Physics Letters. 450:426-430

It is shown how the presence of a chiral compound in solution induces chirality in the surrounding solvent molecules. Using Vibrational Circular Dichroism on camphor dissolved in deuterated chloroform, it is found that the C–D stretch in the latter

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::2f61ed4223ba56ffb462fb3ef6f54877
https://doi.org/10.1016/j.cplett.2007.11.064

Vibrational circular dichroism DFT study on bicyclo[3.3.0]octane derivatives

Autor: Koen Vandyck, Benjamin J. van der Veken, Tom Kuppens, Johan Van der Eycken, Wouter A. Herrebout, Patrick Bultinck, Elke Debie

Publikováno v: Tetrahedron: asymmetry

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, endo -bicyclo[3.3.0]octane-2,6-dione and bicyclo[3.3.0]octa-2,6-dien-2,6-bistriflate were studied by v

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d6f25990d58a78550b62cbcf6253adc2
https://doi.org/10.1016/j.tetasy.2006.11.046