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The AAPS Journal|March 8, 2011
Summary of confirmation cut point discussionsHolly W Smith, Michael Moxness, Robin Marsden
Bioanalysis|March 23, 2011
Bioanalytical considerations in the comparability assessment of biotherapeuticsJean W Lee, Yow-Ming Wang, Michael Moxness, et al.
Cancer Chemotherapy and Pharmacology|April 21, 2015
Comparison of pharmacokinetics and safety of pegfilgrastim administered by two delivery methods: on-body injector and manual injection with a prefilled syringeBing-Bing Yang, Phuong Khanh Morrow, Xikun Wu, et al.
Annals of the Rheumatic Diseases|July 29, 2016
A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumabPrimal Kaur, Vincent Chow, Nan Zhang, et al.
Pediatric Neurology|August 10, 2005
Cerebrospinal fluid ACTH and cortisol in opsoclonus-myoclonus: effect of therapyMichael R Pranzatelli, Kelly Y Chun, Michael Moxness, et al.
The AAPS Journal|July 24, 2009
A step-wise approach for transfer of immunogenicity assays during clinical drug developmentSuzanna Tatarewicz, Michael Moxness, Dohan Weeraratne, et al.
The AAPS Journal|December 17, 2009
Comparing exponentially weighted moving average and run rules in process control of semiquantitative immunogenicity immunoassaysTroy E Barger, Lei Zhou, Michael Hale, et al.
Plos One|August 6, 2016
Use of In Vitro Assays to Assess Immunogenicity Risk of Antibody-Based BiotherapeuticsMarisa K Joubert, Meghana Deshpande, Jane Yang, et al.
Journal of Pharmaceutical and Biomedical Analysis|November 11, 2008
Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology productsGopi Shankar, Viswanath Devanarayan, Lakshmi Amaravadi, et al.
Journal of Immunological Methods|February 16, 2008
Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology productsEugen Koren, Holly W Smith, Elizabeth Shores, et al.
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