Work

Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products

Year: 2008

Type: review

Source: Journal of Pharmaceutical and Biomedical Analysis

DOI: 10.1016/j.jpba.2008.09.020

Authors: Gopi Shankar, Viswanath Devanarayan, Lakshmi Amaravadi, Yu Chen Barrett, Ronald Bowsher, Deborah Finco-Kent, Michele Fiscella, Boris Gorovits, Susan Kirschner, Michael Moxness, Thomas Parish, Valerie Quarmby, Holly Smith, Wendell Smith, Linda A. Zuckerman, Eugen Koren

Institutions: Abbott (United States), Biogen (United States), Bristol-Myers Squibb (United States), MilliporeSigma (United States), Pfizer (United States), Human Genome Sciences (United States), Wyeth, United States Food and Drug Administration, Center for Drug Evaluation and Research, Amgen (United States), Procter & Gamble (United States), Genentech, Eli Lilly (United States), Abbott Vascular (United States)

Language: English

Topic: Biosimilars and Bioanalytical Methods

Subfield: Immunology

Field: Immunology and Microbiology

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: closed

OpenAlex ID: W1967295501

FWCI: 1.919

Cites: 26

Cited by: 627

Related to: 10