I have been asked to recommend some software which can be used by our
biologicals maunfacturing unit.
They typically characterize samples using radio-immunoassays,
fluoro-immunoassays and ELISAs. A typical requirment is to obtain a
signal from a range of calibration samples of known concentration,
construct a calibration curve and then use this to estimate sample
concentrations. The calibration curves are usually nonlinear (e.g.
4-parameter logistic curves).
Everything will need to be documented and validated to meet Good
Manufacturing Practice (GMP) standards.
I am interested in considering stand-alone graphics and curve-fitting
packages, which run under Windows.
I want something which will offer various nonlinear curve and weighting
options from menu choices, which will readily accept data from e.g.
Excel spreadsheets.
It must produce a printed report showing the original data, description
of methodology, estimates with standard errors, goodness of fit
statistics and appropriate graphs.
Our group have created custom SAS applications to perform similar tasks
for our research bioscientists. However, SAS may be a poor choice for
the manufacturing site as it is remote, and there is nobody there with
SAS expertise, so development, maintenance, validation and training
would be difficult.
Volumes of data are modest, and we are not currently considering a LIMS
system.
I would like to hear from allstat members about their experience and
what software is used in their companies.
Thanks
Tim Auton
--
T R Auton PhD MSc C.Math
Head of Biomedical Statistics
Protherics Molecular Design Ltd
Beechfield House
Lyme Green Business Park
Macclesfield
Cheshire SK11 0JL
UK
email: [log in to unmask]
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