Zobrazeno 1 - 3
of 3
pro vyhledávání: '"Greg Sacha"'
Autor:
Serguei Tchessalov, Evgenyi Shalaev, Bakul Bhatnagar, Steven Nail, Alina Alexeenko, Feroz Jameel, Jayasree Srinivasan, Michael Dekner, Ekneet Sahni, Stefan Schneid, Petr Kazarin, Orla McGarvey, Bert Van Meervenne, Vaibhav Kshirsagar, Paritosh Pande, Jens Philipp, Greg Sacha, Ke Wu, Joseph Azzarella, Gayathri Shivkumar, Shreyas Bhatt, Shyam B. Mehta
Publikováno v:
AAPS PharmSciTech. 24
Scale-up and transfer of lyophilization processes remain very challenging tasks considering the technical challenges and the high cost of the process itself. The challenges in scale-up and transfer were discussed in the first part of this paper and i
Autor:
Serguei Tchessalov, Evgenyi Shalaev, Bakul Bhatnagar, Steven Nail, Alina Alexeenko, Feroz Jameel, Jayasree Srinivasan, Michael Dekner, Ekneet Sahni, Stefan Schneid, Petr Kazarin, Orla McGarvey, Bert Van Meervenne, Vaibhav Kshirsagar, Paritosh Pande, Jens Philipp, Greg Sacha, Ke Wu, Joseph Azzarella, Gayathri Shivkumar, Shreyas Bhatt
Publikováno v:
AAPS PharmSciTech. 24
The freeze-drying process scale-up and transfer remain a complicated and non-uniform practice. We summarized inefficient and good practices in these papers and provided some practical advice. It was demonstrated that using the same process set points
Autor:
Paul Coiteux, Greg Sacha, Serguei Tchessalov, William J. Kessler, Michael J. Pikal, Steven J. Ferris, James A. Searles, Lindsay A. Wegiel, Cindy Reiter, Alina Alexeenko, Frank Dimarco, Arnab Ganguly, Evgenyi Shalaev, Steven L. Nail, Ernesto Renzi, T. N. Thompson
Publikováno v:
AAPS PharmSciTech.
Recommended best practices in monitoring of product status during pharmaceutical freeze drying are presented, focusing on methods that apply to both laboratory and production scale. With respect to product temperature measurement, sources of uncertai