Assay Development and Evaluation
Assay Development and Evaluation: A Manufacturer's Perspective Jan S. Krouwer, PhD,
Publisher: AACC Press
ISBN: 1890883816
Edition: Paperback; 2002-07-01
Summary:
Written from the perspective of a manufacturer, this book is intended
to help those who develop and evaluate diagnostic assays to apply
data modeling and analysis techniques that leverage the vast amount
of data collected by manufacturers and by laboratories. Given the
financial, technical, and regulatory forces that exist, sophisticated
development and evaluation studies are often performed in industry,
but these are rarely made public. The key studies are described here.
They include not only evaluation studies, but also financial
modeling, development of specifications, instrument system
reliability, and other applications. Assay Development and Evaluation
is also written from the perspective of a consultant. The information
is relevant not just for consultants, but for anyone who has an idea
and tries to implement it. Just because one is right does not mean
that one's solution will be used. This book describes how to
identify, understand, and deal with the resistance that often occurs
when new solutions are suggested.
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