Hi All: I would like to get some inputs from flow cytometry folks in drug discovery/development areas with regard to the guidelines that the Committee for Proprietary Medicinal Products (CPMP, UK) have set up for initial immunotoxicity (species: rat) screens. These are new regulations that affect all compounds in pre-clinical/clinical development with a huge impact on flow cytometry facilities. Among the panel of parameters that CPMP has put forth includes: 1) bone marrow cellularity (cytospins or flow cytometry) 2) distribution of lymphocyte subsets and NK-cell activity (flow cytometry) 3) primary antibody response to a T-cell dependent antigen (if previous 2 unavailable). The important information that I am seeking is : 1) Are Safety Assessment units in other Pharmaceutical companies aware of this, and if so, are they geared up to meet such a huge demand on personnel and instrumentation to set up screens of this magnitude 2) Have they prioritized the panels etc, etc. Any info will be much appreciated. Regards Padma Narayanan Safety Assessment SmithKline Beecham Phone 610-270-7485
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