Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2579043 | Thérapie | 2012 | 9 Pages |
Abstract
Monoclonal antibodies (MoAb) are very different from other drugs. The Round Table aimed to determine whether the specific characteristics of MoAb have repercussions on their clinical development, evaluation by the health authorities, and long-term monitoring. As regards the structure-activity relationship of MoAb, classification according to mechanism of action (neutralising or agonist MoAb, cytolytic MoAb) is more relevant than to their degree of humanisation. Recommendations on their clinical development would be useful since the early phases give rise to a number of problems and are insufficiently codified. The pharmacokinetic profile is very different from that of other drugs. The concentration-effect relationship is difficult to study since the biomarkers may be apparently disconnected from the therapeutic effect. The methodology for evaluation of MoAb by the agencies, and postmarketing surveillance do not differ from the procedures used for other drugs; however, MoAb bring together a number of specific characteristics as compared with other drugs.
Keywords
HASPK-PDFDAAnti-tumor necrosis factor-αTMDDNOAELMABELMoAbADCCRMPSMRASMRIgGCDREMAPMLCDCnatural killerantibody dependent cellular cytotoxicityEuropean Medicines agencyHERimmunoglobulin GFood and Drug AdministrationAnti-TNFαanti-VEGFPharmacokinetic-pharmacodynamicanti-vascular endothelial growth factorTarget-mediated drug dispositionProgressive multifocal leukoencephalopathycomplementarity determining regionNo observed adverse effect levelMonoclonal antibodies
Related Topics
Health Sciences
Pharmacology, Toxicology and Pharmaceutical Science
Pharmacology, Toxicology and Pharmaceutics (General)
Authors
Gilles Paintaud, Marine Diviné, Philippe Lechat,