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Autor:
Arnab Ganguly, Lisa Hardwick, Serguei Tchessalov, Steven L. Nail, Dan Dixon, Frank Kanka, Anthony Guidinas, T. N. Thompson, Cindy Reiter, Zakaria Yusoff, Ted Tharp, Joseph Azzarella, Prerona Sharma, Petr Kazarin, Alina Alexeenko, Michael J. Pikal
Publikováno v:
AAPS PharmSciTech. 24
Best practices for performing freeze dryer equipment qualification are recommended, focusing on identifying methods to quantify shelf thermal uniformity (also known as “shelf surface uniformity”), equipment capability, and performance metrics of