Zobrazeno 1 - 8
of 8
pro vyhledávání: '"S. Alvandkouhi"'
Autor:
John Chappell, Shannon Rebarchak, Joseph C. Marini, Gregor Schaffar, Andrew Exley, Ronald R. Bowsher, Viswanath Devanarayan, Francesca Civoli, Aparna Kasinath, Vera Koppenburg, Xiao-Yan Cai, Michael Anderson, Philip Oldfield, Meenu Wadhwa, S. Alvandkouhi, Todd Lester
Publikováno v:
The AAPS journal. 22(1)
For biosimilar drug development programs, it is essential to demonstrate that there are no clinically significant differences between the proposed biosimilar therapeutic (biosimilar) and its reference product (originator). Based on a stepwise compreh
Autor:
B. Babbitt, C. Satterwhite, S. Liu, A. Dasilva, Aparna Kasinath, D. Gouty, Xiao-Yan Cai, Vera Koppenburg, D. Peritt, S. Pederson, A. Rudy, V. Kumar, Chun-Hua Cai, M. Ullmann, Jihong Yang, S. Alvandkouhi
Publikováno v:
The AAPS journal. 20(2)
In the published article, the author B. Babbitt was cited as affiliation 9, but should have been cited as affiliation 2. In addition, there are 2 errors in the affiliations. The correct affiliations are shown in this erratum.
Autor:
Vera Koppenburg, Chun-Hua Cai, D. Peritt, S. Alvandkouhi, S. Pederson, A. Dasilva, B. Babbitt, D. Gouty, C. Satterwhite, Jihong Yang, Xiao-Yan Cai, S. Liu, M. Ullmann, V. Kumar, A. Rudy, Aparna Kasinath
Publikováno v:
The AAPS journal. 20(1)
The American Association of Pharmaceutical Scientists (AAPS) biosimilar focus group on nonclinical and clinical assays has developed this manuscript to guide the industry on best practices and testing strategies when developing neutralizing antibody
Akademický článek
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Autor:
Civoli F; Coherus BioSciences, Redwood City, CA, USA. fcivoli@coherus.com., Kasinath A; Syngene International Ltd, Bangalore, India., Cai XY; Accurant Biotech, Inc., Cranbury, New Jersey, USA., Wadhwa M; Medicines and Healthcare Products Regulatory Agency (MHRA), National Institute for Biological Standards and Control (NIBSC), Hertfordshire, UK., Exley A; Regulatory Division, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK., Oldfield P; Philip Oldfield Bioanalytical Consulting, Quebec, Canada., Alvandkouhi S; BioAgilytix Labs, Durham, North Carolina, USA., Schaffar G; Hexal AG , Oberhaching, Germany., Chappell J; Gyros Protein Technologies, Uppsala, Sweden., Bowsher R; B2S Life Sciences, Franklin, Indiana, USA., Devanarayan V; GlaxoSmithKline, Collegeville, Pennsylvania, USA., Marini J; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA., Rebarchak S; Janssen Research & Development, LLC, Spring House, Pennsylvania, USA., Anderson M; Immunologix Laboratories, Tampa, Florida, USA., Koppenburg V; Hexal AG, Holzkirchen, Germany., Lester T; BioAgilytix Labs, Durham, North Carolina, USA.
Publikováno v:
The AAPS journal [AAPS J] 2019 Dec 02; Vol. 22 (1), pp. 7. Date of Electronic Publication: 2019 Dec 02.
Autor:
Gouty D; BioAgilytix Labs, Durham, North Carolina, USA. dominique.gouty@bioagilytix.com., Cai CC; Pfizer Inc, Groton, Connecticut, USA., Cai XY; WuXi AppTec Co. Ltd, Shanghai, China., Kasinath A; Syngene International Ltd, Bangalore, India., Kumar V; Biologics, Dr. Reddy's Laboratories Ltd., Hyderabad, India., Alvandkouhi S; Genentech, Inc, South San Francisco, California, USA., Yang J; Alder Biopharmaceuticals Inc., Bothell, Washington, USA., Pederson S; PAREXEL International Corp, Waltham, Massachusetts, USA., Babbitt B; Pfizer Inc, Groton, Connecticut, USA., Peritt D; Sandoz Biopharmaceuticals/Hexal AG, Holzkirchen, Germany., Rudy A; Merck KGaA, Darmstadt, Germany., Koppenburg V; Charles River Laboratories, Inc., Wilmington, Massachusetts, USA., Dasilva A; Apobiologix, Toronto, Ontario, Canada., Ullmann M; Merck KGA, Geneva, Switzerland., Liu S; Apobiologix, Toronto, Canada., Satterwhite C; Charles River Laboratory, Reno, Nevada, USA.
Publikováno v:
The AAPS journal [AAPS J] 2017 Dec 28; Vol. 20 (1), pp. 25. Date of Electronic Publication: 2017 Dec 28.