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8 results on '"Zezza, Diane"'

1. Regulatory and Quality Considerations for Continuous Manufacturing

Author

Allison, Gretchen, primary, Cain, Yanxi Tan, additional, Cooney, Charles, additional, Garcia, Tom, additional, Bizjak, Tara Gooen, additional, Holte, Oyvind, additional, Jagota, Nirdosh, additional, Komas, Bekki, additional, Korakianiti, Evdokia, additional, Kourti, Dora, additional, Madurawe, Rapti, additional, Morefield, Elaine, additional, Montgomery, Frank, additional, Nasr, Moheb, additional, Randolph, William, additional, Robert, Jean-Louis, additional, Rudd, Dave, additional, and Zezza, Diane, additional

Published
2017
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2. Advancing Product Quality: a Summary of the Second FDA/PQRI Conference

Author

Yu, Lawrence X., Akseli, Ilgaz, Allen, Barbara, Amidon, Gregory, Bizjak, Tara Gooen, Boam, Ashley, Caulk, Margaret, Doleski, David, Famulare, Joseph, Fisher, Adam C., Furness, Scott, Hasselbalch, Brian, Havel, Henry, Hoag, Stephen W., Iser, Robert, Johnson, Bruce D., Ju, Robert, Katz, Paula, Lacana, Emanuela, Lee, Sau L., Lostritto, Richard, McNally, Grace, Mehta, Mehul, Mohan, Ganapathy, Nasr, Moheb, Nosal, Roger, Oates, Mary, O’Connor, Thomas, Polli, Jim, Raju, G. K., Ramanadham, Mahesh, Randazzo, Giuseppe, Rosencrance, Susan, Schwendeman, Anna, Selen, Arzu, Seo, Paul, Shah, Vinod, Sood, Ramesh, Thien, Michael P., Tong, Tony, Trout, Bernhardt L., Tyner, Katherine, Vaithiyalingam, Siva, VanTrieste, Martin, Walsh, Fionnuala, Wesdyk, Russell, Woodcock, Janet, Wu, Geoffrey, Wu, Larisa, Yu, Louis, and Zezza, Diane

Published
2016
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6. Biologics: can there be abbreviated applications, generics, or follow-on products? (Controversial Topics)

Author

Webster, Christopher, Copmann, Thomas, Garnick, Robert, Green, James, Hayes, Mark, Landis, John, Lubiniecki, Anthony, Murano, Genesio, Seamon, Kenneth, Zezza, Diane, and Woollett, Gillian R.

Subjects
Biogen Inc. -- Product information, Biological products industry -- Production processes, Biological products industry -- Product information, Biotechnology industry, Business, Pharmaceuticals and cosmetics industries
Abstract

In this question-and-answer discussion of 'generic' biologics, the authors contend small changes in manufacturing of biologics dramatically affect the safety and efficacy of the therapeutic molecule. During the past few [...]

Published
2003

7. One Product, One Process, One Set of Specifications

Author

Copmann, Tom, Davis, Gregory, Garnick, Rob, Landis, John, Lubiniecki, Anthony, Massa, Tobias, Murano, Gene, Seamon, Kenneth, and Zezza, Diane

Subjects
Eli Lilly and Co. -- Standards, United States. Food and Drug Administration -- Standards, International Conference on Harmonisation -- Standards, Biological products industry -- Standards, Biological products -- Standards, Drugs -- Standards, Pharmaceutical industry -- Standards, Public Health Service Act, Food, Drug and Cosmetic Act, Drug Price Competition and Patent Term Restoration Act of 1984, Business, Pharmaceuticals and cosmetics industries, Standards
Abstract

A Proven Quality Paradigm for the Safety and Efficacy of Biologic Drugs If FDA changes the current policies that preclude 'generic biological drugs,' manufacturers of those products should be held [...]

Published
2001

8. Can There Be Abbreviated Applications, Generics, or Follow-On Products?

Author

Webster, Christopher, Copmann, Thomas, Garnick, Robert, Green, James, Hayes, Mark, Landis, John, Lubiniecki, Anthony, Murano, Genesio, Seamon, Kenneth, Zezza, Diane, and Woollett, Gillian R.

Subjects
BIOLOGICALS, GENERIC drugs
Abstract

Presents questions and answers advisory on generic biologics. Definition of biologic; Meaning of generic biologics; Importance of follow-on biologics to the innovator industry.

Published
2003

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