Zobrazeno 1 - 3
of 3
pro vyhledávání: '"Eric Adamec"'
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:
Eric Adamec, Richard K. Burdick
Publikováno v:
Quality Engineering. 15:383-389
In this paper, we extend results of the typical two-factor gauge repeatability and reproducibility (R&R) study to a situation with three random factors. The objective of this study is to form a confidence interval on a discrimination ratio used to de
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::77b0ecf455cac406ed76ce2fd6c54265
https://doi.org/10.1081/qen-120018036
https://doi.org/10.1081/qen-120018036