Re: Flow Cytometry and Immunotoxicity guidelines

From: Rafael Nunez (rafaeln@vetvir.unizh.ch)
Date: Sat Aug 26 2000 - 03:38:32 EST


Hi Padma, I thank you for your information. In this regard, we just
published a paper in Cytometry 40:353-360 August 2000 by  Kamau, Hurtado,
Muller, Grimm and Nunez  dealing with the Flow cytometry assesment of
allopurinol susceptibility in leishmania infantum promastigote. We believe
that this is the first paper dealing formally with this set of issues. I
hope it will help to your case. Please feel free if you need additional
information. We also submitted  another paper to a parasitology journal
addressing those issues.
regards Rafael

>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


                                     \|/
                                    (o o)
________________________________oOo__(_)__oOo_________________________________
    ___/\_    | Rafael Nunez                  mailto:rafaeln@vetvir.unizh.ch
   /    o \/| | University Inst.for Virology  http://www.vetvir.unizh.ch/
  /        _| | Winterthurerstr. 266a         Telephone: (+41) 1 6358710
 /_/\__/-\/   | 8057 Zurich SWITZERLAND       Faximile : (+41) 1 6358911
______________________________________________________________________________



This archive was generated by hypermail 2b29 : Wed Apr 03 2002 - 11:56:02 EST