title: In vitro end points for the assessment of cellular immune response-modulating drugs.
abstract: BACKGROUND
  The concept of immunotoxicology and the development of a battery of immune-function assays to screen potential immunotoxic compounds have been increasingly used in the past. Immunotoxic outcome generally seems appropriate to evaluate the risk in drug development. Improving this approach is possible, by using methods now available, to study the effect of a chemical compound on the immune system.
  
  
  OBJECTIVE
  The goal of this review is to provide an overview of the current and recent methodologies for testing the immunological effect and immunotoxic risks in drug candidates.
  
  
  METHODS
  The methodological details here discussed include a synthetic description of the immunocompetent cells in cell-mediated immunity and the choice of the most appropriate assay (bioassays, immunoassays, molecular biology techniques, flow cytometry).
  
  
  CONCLUSIONS
  This review offers an assessment of in vitro models to study the toxic impact of (bio)pharmaceuticals on cellular immune system and aid drug scientists in understanding the significance and the methods to approach immunotoxicology.
authors.affiliation: Institute of Neurobiology and Molecular Medicine, CNR, Via Fosso del Cavaliere 100, 00133 Rome, Italy +39 06 4993 4610 ; +39 06 4993 4257 ; Mariapia.Fuggetta@artov.inmm.cnr.it.
authors.forename: Maria Pia
authors.initials: MP
authors.lastname: Fuggetta
authors.forename: Giulia
authors.initials: G
authors.lastname: Lanzilli
authors.forename: Daniela
authors.initials: D
authors.lastname: Fioretti
authors.forename: Monica
authors.initials: M
authors.lastname: Rinaldi