title: Quality assessment issues of new immunosuppressive drugs and experimental experience.
abstract: There are established quality assessment schemes for the two immunosuppressive drugs that have entered routine clinical use: cyclosporine and tacrolimus. These two drugs, together with sirolimus and mycophenolic acid, have been the subject of recent consensus panel reports that have reached broad agreement on several issues relating to therapeutic monitoring of these agents. While the current quality assessment schemes are not based on validated reference methods, the data they yield on comparative assay performance are of value as a guide to patient management and for clinical studies of drug efficacy.
authors.affiliation: Analytical Unit, St. George's Hospital Medical School, London, England.
authors.forename: D W
authors.initials: DW
authors.lastname: Holt
authors.forename: K
authors.initials: K
authors.lastname: Jones
authors.forename: T
authors.initials: T
authors.lastname: Lee
authors.forename: P
authors.initials: P
authors.lastname: Stadler
authors.forename: A
authors.initials: A
authors.lastname: Johnston
mesh_terms: D016572:Cyclosporine / Q000097:blood / Q000627:therapeutic use; D016903:Drug Monitoring / Q000592:standards; D006801:Humans; D007166:Immunosuppressive Agents / Q000097:blood / Q000627:therapeutic use*; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000097:blood; D011090:Polyenes / Q000097:blood; D020123:Sirolimus; D016559:Tacrolimus / Q000097:blood / Q000627:therapeutic use
chemical_list: D007166:Immunosuppressive Agents; D011090:Polyenes; D016572:Cyclosporine; D009173:Mycophenolic Acid; D020123:Sirolimus; D016559:Tacrolimus