Zobrazeno 1 - 10
of 16
pro vyhledávání: '"Mark Alasandro"'
Autor:
Mark Alasandro, Dilip Choudhury, Kim Huynh-Ba, Jianmei Kochling, Christopher Latoz, Laure Larkin, Lori McCaig, Nanda Subbarao, Yan Wu, Yajie Zhang
Publikováno v:
AAPS Open, Vol 7, Iss 1, Pp 1-9 (2021)
Abstract The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on “Vaccine Stability Considerations to Enable Rapid Development and Deployment”, on March 24-25, 2021. The workshop included
Externí odkaz:
https://doaj.org/article/a1c20c01b5e340cdb6cab242725d2254
Autor:
Vivian Gray, Andreas Abend, Mark Alasandro, Piero Armenante, Tessa Carducci, Bryan Crist, Fasheng Li, Xujin Lu, Margareth Marques, Kevin Moore, Beverly Nickerson
Publikováno v:
Dissolution Technologies. 29:230-236
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::88fcbcf1544e23f4b194b9adf0c91438
https://doi.org/10.14227/dt290422p230
https://doi.org/10.14227/dt290422p230
Autor:
Christopher Latoz, Laure Larkin, Nanda Subbarao, Lori McCaig, Kim Huynh-Ba, Yan Wu, Mark Alasandro, Yajie Zhang, Dilip Choudhury, Jianmei Kochling
Publikováno v:
Aaps Open
AAPS Open, Vol 7, Iss 1, Pp 1-9 (2021)
AAPS Open, Vol 7, Iss 1, Pp 1-9 (2021)
The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on “Vaccine Stability Considerations to Enable Rapid Development and Deployment”, on March 24-25, 2021. The workshop included distingu
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5f2533c559179d151da8a094da7659b3
https://pubmed.ncbi.nlm.nih.gov/34869830
https://pubmed.ncbi.nlm.nih.gov/34869830
Autor:
Mark Alasandro, Thomas A. Little
Publikováno v:
AAPS PharmSciTech. 17:523-527
A statistical modeling tool is presented that enables real-time viewing of how changes in method, process, and stability variability/bias impact product acceptance rate. The tool can be used to set and justify specifications. As needed, additional so
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e2a781f63861aebffe4fd834d60259f0
https://doi.org/10.1208/s12249-015-0380-3
https://doi.org/10.1208/s12249-015-0380-3
Autor:
David Lavrich, Ketan Shah, Kim Huynh-Ba, Anita L. Freed, Mark Alasandro, Ramesh Raghavachari, Yan Wu
Publikováno v:
AAPS PharmSciTech. 16:986-991
In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet th
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a8f9e7d807372748854413cdba5b72bb
https://doi.org/10.1208/s12249-015-0334-9
https://doi.org/10.1208/s12249-015-0334-9
Publikováno v:
AAPS Open, Vol 3, Iss 1, Pp 1-10 (2017)
There has been significant growth in the use of modeling tools to accelerate development and enhance pharmaceutical quality. Among these are empirical and semi-empirical modeling of accelerated stability studies which can be used to predict product s
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::33ddcd12a00cd357046e570795f5b602
https://doi.org/10.1186/s41120-017-0018-5
https://doi.org/10.1186/s41120-017-0018-5
Publikováno v:
Journal of Chromatography A. 917:63-73
This article presents a systematic approach to investigate, document, and eliminate pharmaceutical HPLC assay bias using experimental design. This is the first article to describe the application of experimental design in the area of assay bias. It i
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bdce39e9320db34b5cbe2140ab1c81e0
https://doi.org/10.1016/s0021-9673(01)00670-7
https://doi.org/10.1016/s0021-9673(01)00670-7
Publikováno v:
Journal of High Resolution Chromatography. 21:161-168
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::af5e790c53d72c164b144d149f3aa797
https://doi.org/10.1002/(sici)1521-4168(19980301)21:3<161::aid-jhrc161>3.0.co
https://doi.org/10.1002/(sici)1521-4168(19980301)21:3<161::aid-jhrc161>3.0.co
Publikováno v:
Journal of Chromatography A. 769:145-153
Capillary electrochromatography was employed to separate the antibacterial 3-[4-(methylsulfinyl) phenyl]-5S-acetamidomethyl-2-oxazolidinone from its related S-oxidation products. The separation was optimized by a systematic search for the optimal sep
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::42caddd1afc9f7146983a692d27e55f5
https://doi.org/10.1016/s0021-9673(97)00081-2
https://doi.org/10.1016/s0021-9673(97)00081-2
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 14:1539-1546
Reversed phase liquid chromatography, micellar electrokinetic chromatography, and packed column supercritical fluid chromatography were used to measure the amount of Losartan Potassium drug substance in pharmaceutical tablets. Tablet extract samples
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::99ce0fd0353cd5b064640949d87ef6aa
https://doi.org/10.1016/0731-7085(96)01740-2
https://doi.org/10.1016/0731-7085(96)01740-2