Articles by Mary Ann Gorko - Pharmaceutical Technology

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Articles by Mary Ann Gorko

Mary Ann Gorko

principal statistician

Mary Ann Gorko is principal statistician at AstraZeneca.
Articles
Overcoming Disincentives to Process Understanding in the Pharmaceutical CMC Environment
September 2, 2007
By: Laura Foust , Myron Diener , Mary Ann Gorko , Jeff Hofer , Gregory Larner , David LeBlond , Jerry Lewis , Dennis Sandell , Tim Schofield , Kim Vukovinsky , Ed Warner

Larger and strategic sampling and testing plans can improve process understanding and characterization.
Identification of Out-of-Trend Stability Results
April 2, 2003
By: Mary Ann Gorko

Representatives from PhRMA member companies discuss the growing concern about out-of-trend stability data, including possible statistical approaches and the implementation challenges to identifying OOT results.

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