Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
Top Cited Papers
- 15 December 2008
- journal article
- review article
- Published by Elsevier BV in Journal of Pharmaceutical and Biomedical Analysis
- Vol. 48 (5), 1267-1281
- https://doi.org/10.1016/j.jpba.2008.09.020
Abstract
No abstract availableKeywords
This publication has 23 references indexed in Scilit:
- Characteristics and Outcome of Chinese Patients with Both Antineutrophil Cytoplasmic Antibody and Antiglomerular Basement Membrane AntibodiesNephron Clinical Practice, 2007
- A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugsNature Biotechnology, 2007
- Scientific and regulatory considerations on the immunogenicity of biologicsTrends in Biotechnology, 2006
- Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodiesJournal of Pharmaceutical and Biomedical Analysis, 2005
- Validation of Serological Correlate of Protection for Meningococcal C Conjugate Vaccine by Using Efficacy Estimates from Postlicensure Surveillance in EnglandClinical and Vaccine Immunology, 2003
- Immunologic effects of insulin lispro [Lys (B28), Pro (B29) human insulin] in IDDM and NIDDM patients previously treated with insulinDiabetes, 1996
- Clinical correlations of Anti-Gm1 antibodies in amyotrophic lateral sclerosis and neuropathiesMuscle & Nerve, 1991
- Detection of Antibodies Directed against a Liver-Specific Membrane Lipoprotein in Patients with Acute and Chronic Active HepatitisThe New England Journal of Medicine, 1978
- Epstein‐barr virus (EBV) antibody in patients treated by radical radiotherapy for head and neck cancerJournal of Surgical Oncology, 1978
- HUMAN IMMUNITY TO THE MENINGOCOCCUSThe Journal of Experimental Medicine, 1969