Use of nonclinical toxicity studies to support biosimilar antibody development.

Autor: Mihalcik L; Amgen Inc., One Amgen Drive, Thousand Oaks, CA, USA., Chow V; Amgen Inc., One Amgen Drive, Thousand Oaks, CA, USA., Ramchandani M; Amgen Inc., One Amgen Drive, Thousand Oaks, CA, USA., Hinkle B; Amgen Inc., One Amgen Drive, Thousand Oaks, CA, USA., McBride HJ; Amgen Inc., One Amgen Drive, Thousand Oaks, CA, USA., Lebrec H; Amgen Inc., One Amgen Drive, Thousand Oaks, CA, USA. Electronic address: hlebrec@amgen.com.
Jazyk: angličtina
Zdroj: Regulatory toxicology and pharmacology : RTP [Regul Toxicol Pharmacol] 2021 Jun; Vol. 122, pp. 104912. Date of Electronic Publication: 2021 Mar 01.
DOI: 10.1016/j.yrtph.2021.104912
Databáze: MEDLINE