Zobrazeno 1 - 4
of 4
pro vyhledávání: '"Donnie Pulliam"'
Autor:
Megan McMahon, Helen Williams, Elke Debie, Mingkun Fu, Robert Bujalski, Fenghe Qiu, Yan Wu, Hanlin Li, Jin Wang, Cherokee Hoaglund-Hyzer, Donnie Pulliam
Publikováno v:
AAPS Open, Vol 6, Iss 1, Pp 1-11 (2020)
Abstract 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 under
Externí odkaz:
https://doaj.org/article/d72552a8dab247988747c117598e117e
Autor:
Cheryl Martin, Yelizaveta Babayan, Chaitanya S. Wannere, Donnie Pulliam, Fenghe Qiu, Ping Zhuang, Jin Wang, Michael Lesslie, Pat Forenzo, Lars Gruenig, Megan McMahon, Susan Smith, Cherokee Hoaglund-Hyzer, Brian P. Regler, Eric Adamec
Publikováno v:
Journal of Pharmaceutical Innovation. 17:856-866
Purpose This paper summarizes results from a recent pharmaceutical industry survey to understand the adoption status of science- and risk-based approaches in pharmaceutical stability (lean stability) in regulatory submissions across the full pharmace
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::5e4b345bb35f8781ec0f1369c176fabe
https://doi.org/10.1007/s12247-021-09540-x
https://doi.org/10.1007/s12247-021-09540-x
Autor:
Cherokee S. Hoaglund Hyzer, Bruno Catacchio, Donnie Pulliam, Mingkun Fu, Chait Wannere, Yelizaveta Babayan, Allison L. Dill, Eric Adamec, Megan McMahon, Fenghe Qiu, Angela Coon, Robert Timpano, Lars Gruenig, Karina Szymulanska-Ramamurthy, Michael Lesslie, Brian P. Regler
Publikováno v:
Journal of Pharmaceutical Innovation. 16:566-574
Purpose Lean stability is a science- and risk-based initiative which utilizes the enhanced understanding of drug substance and drug product physical and chemical characteristics to (1) reduce and optimize the design of standard stability protocols; (
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4437b626ad512d2419274099ad60dd05
https://doi.org/10.1007/s12247-020-09463-z
https://doi.org/10.1007/s12247-020-09463-z
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
http://link.springer.com/article/10.1186/s41120-020-00034-7