Application of a design of experiment approach in the development of a sensitive bioanalytical assay in human plasma
Dawes, Michelle L., Bergum, James S., Schuster, Alan E., Aubry, Anne-Françoise
Published in Journal of pharmaceutical and biomedical analysis (01.11.2012)
Published in Journal of pharmaceutical and biomedical analysis (01.11.2012)
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Journal Article
Control Strategy for the Manufacture of Brivanib Alaninate, a Novel Pyrrolotriazine VEGFR/FGFR Inhibitor
Lobben, Paul C, Barlow, Evan, Bergum, James S, Braem, Alan, Chang, Shih-Ying, Gibson, Frank, Kopp, Nathaniel, Lai, Chiajen, LaPorte, Thomas L, Leahy, David K, Müslehiddinoğlu, Jale, Quiroz, Fernando, Skliar, Dimitri, Spangler, Lori, Srivastava, Sushil, Wasser, Daniel, Wasylyk, John, Wethman, Robert, Xu, Zhongmin
Published in Organic process research & development (21.08.2015)
Published in Organic process research & development (21.08.2015)
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Journal Article
Improvement of sordarin production through process optimization: combining traditional approaches with DOE
Tully, Thomas P, Bergum, James S, Schwarz, Steven R, Durand, Susan C, Howell, Jeffrey M, Patel, Ramesh N, Cino, Paul M
Published in Journal of industrial microbiology & biotechnology (01.03.2007)
Published in Journal of industrial microbiology & biotechnology (01.03.2007)
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Journal Article
Evaluation of the Performance Characteristics of Bilayer Tablets: Part I. Impact of Material Properties and Process Parameters on the Strength of Bilayer Tablets
Kottala, Niranjan, Abebe, Admassu, Sprockel, Omar, Bergum, James, Nikfar, Faranak, Cuitiño, Alberto M.
Published in AAPS PharmSciTech (01.12.2012)
Published in AAPS PharmSciTech (01.12.2012)
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Journal Article
Recommendations for the Assessment of Blend and Content Uniformity: Modifications to Withdrawn FDA Draft Stratified Sampling Guidance
Garcia, Thomas, Bergum, James, Prescott, James, Tejwani, Ravindra, Parks, Thomas, Clark, Jon, Brown, William, Muzzio, Fernando, Patel, Samir, Hoiberg, Charles
Published in Journal of pharmaceutical innovation (01.03.2015)
Published in Journal of pharmaceutical innovation (01.03.2015)
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Journal Article
Assessment of Blend and Content Uniformity. Technical Discussion of Sampling Plans and Application of ASTM E2709/E2810
Bergum, James, Parks, Thomas, Prescott, James, Tejwani, Ravindra, Clark, Jon, Brown, William, Muzzio, Fernando, Patel, Samir, Hoiberg, Charles
Published in Journal of pharmaceutical innovation (01.03.2015)
Published in Journal of pharmaceutical innovation (01.03.2015)
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Journal Article
Evaluation of the Performance Characteristics of Bilayer Tablets: Part II. Impact of Environmental Conditions on the Strength of Bilayer Tablets
Kottala, Niranjan, Abebe, Admassu, Sprockel, Omar, Bergum, James, Nikfar, Faranak, Cuitiño, Alberto M.
Published in AAPS PharmSciTech (01.12.2012)
Published in AAPS PharmSciTech (01.12.2012)
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Journal Article
An Example of Utilizing Mechanistic and Empirical Modeling in Quality by Design
Hallow, Daniel M., Mudryk, Boguslaw M., Braem, Alan D., Tabora, Jose E., Lyngberg, Olav K., Bergum, James S., Rossano, Lucius T., Tummala, Srinivas
Published in Journal of pharmaceutical innovation (01.12.2010)
Published in Journal of pharmaceutical innovation (01.12.2010)
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Journal Article
Acceptance limits for the new ICH USP 29 content-uniformity test
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Magazine Article
Trade Publication Article
Statistical Considerations in Design Space Development
Altan, Stan, Bergum, James, Pfahler, Lori, Senderak, Edith, Sethuraman, Shanthi, Vukovinsky, Kim Erland
Published in Pharmaceutical Technology (01.07.2010)
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Published in Pharmaceutical Technology (01.07.2010)
Trade Publication Article
A proposed content-uniformity test for large sample sizes
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Magazine Article
Trade Publication Article
Statistical considerations in design space development: Part I of III
Altan, Stan, Bergum, James, Pfahler, Lori, Senderak, Edith, Sethuraman, Shanthi, Vukovinsky, Kim Erland
Published in Pharmaceutical technology (2003) (01.07.2010)
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Published in Pharmaceutical technology (2003) (01.07.2010)
Magazine Article
Statistical considerations in design space development: part III of III
Altan, Stan, Bergum, James, Pfahler, Lori, Senderak, Edith, Sethuraman, Shanthi, Vukovinsky, Kim Erland
Published in Pharmaceutical Technology (01.09.2010)
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Published in Pharmaceutical Technology (01.09.2010)
Magazine Article
Trade Publication Article
Statistical considerations in design space development: part II of III
Altan, Stan, Bergum, James, Pfahler, Lori, Senderak, Edith, Sethuraman, Shanthi, Vukovinsky, Kim Erland
Published in Pharmaceutical Technology (01.08.2010)
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Published in Pharmaceutical Technology (01.08.2010)
Magazine Article
Trade Publication Article