Zobrazeno 1 - 10
of 19
pro vyhledávání: '"Patrick J. Jansen"'
Autor:
Steven W. Baertschi, Chloe Wang, Chris Foti, Andreas Kuemmell, Gabriela Araujo, John M. Campbell, Dorina Kotoni, Neal Adams, Stacey Marden, Leonardo R. Allain, Patrick J. Jansen, Todd Zelesky, Juçara Ribeiro Franca, Steven Hostyn, Gregory Rullo, Gregory W. Sluggett, Renan Azevedo, Ana Cláudia O. Santos, Simon R. Hicks
Publikováno v:
Journal of pharmaceutical sciences. 111(2)
Stress testing (also known as forced degradation) of pharmaceutical products has long been recognized as a critical part of the drug development process, providing foundational information related to intrinsic stability characteristics and to the dev
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c11151b38830af969a5013b1688ad2d1
https://pubmed.ncbi.nlm.nih.gov/34111446
https://pubmed.ncbi.nlm.nih.gov/34111446
Autor:
Steven W. Baertschi, Craig A. J. Kemp, Patrick J. Jansen, W. Smith, Karen A. McCune, Douglas E. Dorman
Publikováno v:
Journal of Pharmaceutical Sciences. 105:3256-3268
Stress-testing (forced degradation) studies have been conducted on pemetrexed disodium heptahydrate (1) (LY231514·2Na·7H2O) drug substance in order to identify its likely degradation products and establish its degradation pathways. Solid samples of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8b50dec6b739d7fa325d16117866843b
https://doi.org/10.1016/j.xphs.2016.06.029
https://doi.org/10.1016/j.xphs.2016.06.029
Autor:
Andreas Kaerner, Patrick J. Jansen, Matthew Clemens, Tim A. Smitka, Steven W. Baertschi, Lindsay Maxwell-Backer, Jerry R. Draper, K. Wayne Taylor
Publikováno v:
Journal of pharmaceutical sciences. 108(9)
Prasugrel hydrochloride is the active ingredient in Effient™, a thienopyridine platelet inhibitor. An extensive study of the degradation chemistry of prasugrel hydrochloride (LY640315 hydrochloride) has been carried out on the drug substance (part
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3a888408d554366a2f98bbc09fb6964f
https://pubmed.ncbi.nlm.nih.gov/30981754
https://pubmed.ncbi.nlm.nih.gov/30981754
Autor:
Patrick J. Jansen, Mark A. Strege, Allison L. Dill, Linda M. Osborne, Tim A. Smitka, Jerry R. Draper, Evan M. Hetrick, Brian W. Pack, Jonas Y. Buser, Robert M. Montgomery, Steven W. Baertschi
Publikováno v:
Organic Process Research & Development. 19:1458-1464
Galunisertib is a kinase inhibitor designed to selectively inhibit TGF-β signaling. Drug substance stress degradation studies performed during clinical development demonstrated two degradation products via oxidation of the nitrogen(s) of the pyridin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6445baa28e8da73855f7823ca45d8b6c
https://doi.org/10.1021/acs.oprd.5b00112
https://doi.org/10.1021/acs.oprd.5b00112
Autor:
Chris Foti, Allen C. Templeton, Hanne Hjorth Tønnesen, Patrick J. Jansen, Robert A. Reed, S Kristensen, Steven W. Baertschi, David E. Clapham
Publikováno v:
Baertschi, S W, Clapham, D, Foti, C, Jansen, P J, Kristensen, S, Reed, R A, Templeton, A C & Tønnesen, H H 2013, ' Implications of in-use photostability : proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products, part 1: drug products administered by injection ', Journal of Pharmaceutical Sciences, vol. 102, no. 11, pp. 3888-3899 . https://doi.org/10.1002/jps.23717
Basic guidance on the photostability testing of pharmaceuticals, designed to cover manufacturing and storage over shelf life, has long been established within ICH Q1(ICH,B 10 , but the guideline does not cover the photostability of drugs during or af
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::19447913bc8e12dab4f4a1cce21d54ce
https://doi.org/10.1002/jps.23717
https://doi.org/10.1002/jps.23717
Autor:
Michele L. Williamson, R. Brian Scherer, Steven W. Baertschi, Michael E. Kopach, Cherokee S. Hoaglund Hyzer, Patrick J. Jansen
Publikováno v:
Journal of pharmaceutical sciences. 106(5)
Edivoxetine (LY2216684 HCl), although a chemically stable drug substance, has shown the tendency to degrade in the presence of carbohydrates that are commonly used tablet excipients, especially at high excipient:drug ratios. The major degradation pro
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::67d67cdd9856f27cea2b8c161ab3ebf9
https://pubmed.ncbi.nlm.nih.gov/28159638
https://pubmed.ncbi.nlm.nih.gov/28159638
INTRODUCTION As described in chapter 1, stress testing is the main tool that is used to predict stability-related problems, develop analytical methods, and identify degradation products and pathways. Stability-related issues can affect many areas, in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::eff0e14e71408b03666f5ed982c7e955
https://doi.org/10.3109/9781439801802-6
https://doi.org/10.3109/9781439801802-6
The assessment of degradation in pharmaceutical products involves two aspects of analytical measurement. First, a selective analytical method must be available for accurate assay of the parent drug compound, in order to correctly measure any loss. Se
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ebd4e4ef548ce29201cd50577f97be32
https://doi.org/10.3109/9781439801802-13
https://doi.org/10.3109/9781439801802-13
Autor:
Nick Toltl, Steven W. Baertschi, Colette O’Shea, Patrick J. Jansen, Timothy J. Wozniak, Bernard A. Olsen
Publikováno v:
Journal of pharmaceutical and biomedical analysis. 125
An analytical artifact peak appearing to be an impurity was observed intermittently among several laboratories performing HPLC analyses of olanzapine drug substance and formulation samples. The artifact peak was identified as Cu(I) that was formed fr
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::48d82c6bdc20c6bc65ed6bd2afee7cb6
https://pubmed.ncbi.nlm.nih.gov/27023131
https://pubmed.ncbi.nlm.nih.gov/27023131
Autor:
Marcela Nefliu, Steven W. Baertschi, Paul A. Harmon, Todd Zelesky, Gregory W. Sluggett, Patrick J. Jansen, Christopher James Foti
Publikováno v:
Journal of pharmaceutical sciences. 104(12)
We report artifactual degradation of pharmaceutical compounds containing primary and secondary amines during peroxy radical-mediated oxidative stress carried out using azoalkane initiators. Two degradation products were detected when model drug compo
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6a6964589b3150a8eadd33b215c9dca5
https://pubmed.ncbi.nlm.nih.gov/26565996
https://pubmed.ncbi.nlm.nih.gov/26565996