title: Monoclonal Antibodies for Therapeutic Use: Specific           Characteristics of Clinical Development, Evaluation by the Agencies, and Long-term           Monitoring of Safety.
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.
authors.affiliation: François Rabelais University Tours; CNRS UMR 7292; CHRU of Tours, Pharmacology-Toxicology Laboratory, Tours, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Paintaud
authors.forename: Marine
authors.initials: M
authors.lastname: Diviné
authors.forename: Philippe
authors.initials: P
authors.lastname: Lechat
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D006801:Humans; D012449:Safety
chemical_list: D000911:Antibodies, Monoclonal