Analytical approaches to ensure product quality -- AAPS Joint Face-to-Face Meeting of the Stability, the Pharmaceutical Impurities, and the CMC Statistics Focus Groups, April 6th, 2016 in Gaithersburg, MD
Huynh-Ba, Kim, Larner, Greg, Strickland, Helen, Choudhury, Dilip, Wu, Yan, Hofer, Jeff, Wang, Zhenyu, Schofield, Timothy
Published in AAPS open (14.01.2017)
Published in AAPS open (14.01.2017)
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Journal Article
Planning Split-Apheresis Designs for Demonstrating Comparability of Cellular and Gene Therapy Products
Burdick, Richard, Hofer, Jeff, Karl, Andrew, Rushing, Heath
Published in The AAPS journal (16.09.2024)
Published in The AAPS journal (16.09.2024)
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Journal Article
Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach
Abdel-Kader, Hafez, Argentine, Mark, Hofer, Jeff, Benz, Nancy, Burdick, Rick, Chatfield, Marion, Diana, Frank, Fang, Hui, Huang, Yuan, Karmarkar, Shreekant, Nair, Lakshmy M, Natishan, Theresa, Pless, Andrea M, Wang, Qinggang, Williams, Zeena
Published in Pharmaceutical technology Europe (01.10.2014)
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Published in Pharmaceutical technology Europe (01.10.2014)
Journal Article
Analytical method comparability in registration and post-approval stages: a risk-based approach: a risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods
Abdel-Kader, Hafez, Argentine, Mark, Hofer, Jeff, Benz, Nancy, Burdick, Rick, Chatfield, Marion, Diana, Frank, Fang, Hui, Huang, Yuan, Karmarkar, Shreekant, Nair, Lakshmy M, Natishan, Theresa, Pless, Andrea M, Wang, Qinggang, Williams, Zeena
Published in Pharmaceutical technology Europe (01.10.2014)
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Published in Pharmaceutical technology Europe (01.10.2014)
Journal Article
Development of a Content Uniformity Test Suitable for Large Sample Sizes
Sandell, Dennis, Vukovinsky, Kim, Diener, Myron, Hofer, Jeff, Pazdan, James, Timmermans, Joep
Published in Drug information journal (01.07.2006)
Published in Drug information journal (01.07.2006)
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Journal Article
Statistics in Pharmaceutical Development and Manufacturing/Discussion/Discussion/Discussion/Discussion/Rejoinder
Peterson, John J, Snee, Ronald D, McAllister, Paul R, Schofield, Timothy L, Carella, Anthony J, Hoerl, Roger W, Hofer, Jeff, Torbeck, Lynn, Tsong, Yi, Kelly, Roswitha, Shen, Meiyu, Zhong, Jinglin
Published in Journal of quality technology (01.04.2009)
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Published in Journal of quality technology (01.04.2009)
Journal Article
Statistics in Pharmaceutical Development and Manufacturing. Discussion
PETERSON, John J, SNEE, Ronald D, SHEN, Meiyu, JINGLIN ZHONG, MCALLISTER, Paul R, SCHOFIELD, Timothy L, CARELLA, Anthony J, HOERL, Roger W, HOFER, Jeff, TORBECK, Lynn, TSONG, Yi, KELLY, Roswitha
Published in Journal of quality technology (2009)
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Published in Journal of quality technology (2009)
Journal Article
Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach
Abdel-Kader, Hafez, Argentine, Mark, Benz, Nancy, Burdick, Rick, Chatfield, Marion, Diana, Frank, Fang, Hui, Hofer, Jeff, Huang, Yuan, Karmarkar, Shreekant, Nair, Lakshmy M, Natishan, Theresa, Pless, Andrea M, Wang, Qinggang, Williams, Zeena
Published in Pharmaceutical Technology (01.10.2014)
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Published in Pharmaceutical Technology (01.10.2014)
Trade Publication Article
Overcoming disincentives to process understanding in the pharmaceutical CMC environment
Foust, Laura, Diener, Myron, Gorko, Mary Ann, Hofer, Jeff, Larner, Greg, LeBlond, David, Lewis, Jerry, Sandell, Dennis, Schofield, Tim, Vukovinsky, Kim, Warner, Ed
Published in Pharmaceutical Technology (01.09.2007)
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Published in Pharmaceutical Technology (01.09.2007)
Magazine Article
Trade Publication Article
Analytical method comparability in registration and post-approval stages: a risk-based approach: a risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods
Abdel-Kader, Hafez, Argentine, Mark, Benz, Nancy, Burdick, Rick, Chatfield, Marion, Diana, Frank, Fang, Hui, Hofer, Jeff, Huang, Yuan, Karmarkar, Shreekant, Nair, Lakshmy M, Natishan, Theresa, Pless, Andrea M, Wang, Qinggang, Williams, Zeena
Published in Pharmaceutical technology (2003) (01.10.2014)
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Published in Pharmaceutical technology (2003) (01.10.2014)
Magazine Article