Search Results - "Lepore, John V"

Case Studies in the Development of Drug Substance Control Strategies by Thomson, Nicholas M, Singer, Robert, Seibert, Kevin D, Luciani, Carla V, Srivastava, Sushil, Kiesman, William F, Irdam, Erwin A, Lepore, John V, Schenck, Luke

“…A series of case histories from IQ consortium member companies are presented in order to exemplify many of the different elements of drug substance control…”
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Part 3: Enhanced Approaches to the Development of the Control Strategy and its Implementation in the Manufacturing Process Description by Popkin, Matt E., Omer, Batool Ahmed, Seibert, Kevin D., Luciani, Carla V., Srivastava, Sushil, Hobson, Lindsay, Lepore, John V.

“…A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced Quality by…”
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The Delivery of Flexibility from the Application of QbD to API Development by Popkin, Matt E., Borman, Phil J., Omer, Batool Ahmed, Seibert, Kevin D., Srivastava, Sushil, Lepore, John V., Hobson, Lindsay, Donaubauer, John, Curran, Timothy, Ide, Nathan, Tymonko, Steven, Looker, Adam, Kallemeyn, Jeffrey M.

“…This paper by IQ consortium member companies will describe how the application of the ICH Q11 vision for enhanced QbD development can lead to flexibility…”
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