Zobrazeno 1 - 2
of 2
pro vyhledávání: '"Eileen Berkay"'
Autor:
Shawn Novick, Ping Yin, Juliana Kretsinger, Martin H. Gastens, Margaret Ruesch, Ming Zeng, Eileen Berkay, Luca Benetti, John T. Stults, Ann Subashi, Barbara Rellahan, Neha Frantz, Wayne P. Kelley, Corné J.M. Stroop, Laura Pack, David Cirelli, Michael J. Lewis
Publikováno v:
Journal of Pharmaceutical Sciences. 110:771-784
Commercial specifications for a new biotherapeutic product are a critical component of the product's overall control strategy that ensures safety and efficacy. This paper describes strategies for setting commercial specifications as proposed by a con
Autor:
Matthew G. Krebs, Melissa L. Johnson, Byoung Chul Cho, Se-Hoon Lee, Rachel Kudgus-Lokken, Donna Zemlickis, Anna Mitselos, Eileen Berkay, Joshua M. Bauml, Roland E. Knoblauch, Peter Hellemans, Anna Minchom
Publikováno v:
Cancer Research. 82:CT198-CT198
Background: Amivantamab, an epidermal growth factor receptor (EGFR)-MET bispecific antibody, is approved for patients with advanced EGFR exon 20 insertion non-small cell lung cancer after progression on platinum-based chemotherapy. First-dose intrave