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A concise and comprehensive guide to current statistical concepts
Editors:
F. Brown
A. Mire-Sluis
Developments in Biologicals,
Vol. 107
The Design and Analysis
of Potency Assays for
Biotechnology Products
Editors:
Brown, F. (Greenport, N.Y.);
Mire-Sluis, A. (Carlsbad, Calif.)
National Institute for Biological
Standards and Control,
London, October 2000
VIII + 144 p., 20 fig., 12 tab.,
soft cover, 2002
CHF 140.– / EUR 100.– / USD 121.75
ISBN 3–8055–7425–8
Prices subject to change
EUR price for Germany,
USD price for USA only
Fields of Interest:
Immunology, Pharmaceutics,
Biotechnology, Data Processing/
Medical Statistics, Laboratory
The Design and Analysis
of Potency Assays for
Biotechnology Products
The complexity of the structure and
function of many biotechnology-derived
products necessitates a wide range of
analytical procedures to adequately
characterize the product. Physicochemical
techniques provide little, if any, information
regarding the potency of biologicals.
Therefore, the development and analysis
of biological assays that measure the
ability of a material to elicit a function
are essential to successful product development.
Bioassays such as in vivo or
cell-based assays often exhibit inherent
variability due to the use of living materials.
It is necessary to design and execute
Contents
General Assay Performance
Characteristics – Statistical Measures
Characterization and Implications of Bioassay
Variation: Ostland, M.
Strip-Plot Designs, Mixed Models, and
Comparison between Linear and Non-Linear
Models for Microtitre Plate Bioassays:
Lansky, D.
Validation of Biological Assays: Schofield, T.
Potency Estimation by Parallel Line
Bioassay Techniques
Statistical Considerations in the Design
and Analysis of Parallel Line Assays:
Gaines Das, R.E.
Selected Topics in Parallel Line Bioassay:
Giltinan, D.
Parallel Line Bioassay in Practice:
Norwood, B.J.
A Case Study: Development of a Bioassay
for IL-1ra: Wolf, J.
bioassays to reduce variability as much as
possible whilst enabling statistically valid
measures of the reproducibility of potency
estimates.
The articles in this volume aim to describe
statistical approaches currently being
used in the design and analysis of potency
assays for biotechnology products, and
to identify factors influencing the appropriate
choice of these approaches. Issues
that impact on assay design, implementation,
validation and interpretation are
discussed, both from the analyst’s and
statistician’s perspective.
Extensions to Parallel Line Bioassay
Analysis
Constrained Four Parameter Logistic Model:
Altan, S.; Manola, A.; Davidian, M.;
Raghavarao, D.
An Aspect of Discrete Data Analysis: Fitting a
Beta-Binomial Distribution to the Hospitals’
Data: Altham, P.M.E.
Special Cases for Assay Design
and Analysis
Methods for the Analysis and Design of
Limiting Dilution Assays: Matthews, J.N.S.
Analysis of an in vivo Assay for Inactivated
Polio Vaccine: Heath, A.B.
Analysis to What Aims? Setting
Specifications
Setting Specifications for Potency Assays –
Basic Principles: Mire-Sluis, A.R.
Statistical Approaches to Specification Setting
with Application to Bioassay: Dillard, B.
International Specification Setting –
EP Perspectives: Calam, D.H.

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Developments in Biologicals
Series Editor:
Brown, F. (Greenport, N.Y.)
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KP 02010 (17.06.02) Printed in Switzerland (1.01;1.27;1.04;1.08;1.17)
Vol. 103
Vol. 106:
Evolving Scientific
and Regulatory
Perspectives on
Cell Substrates for
Vaccine Development
Double Tree Hotel,
Rockville, Md., USA,
September 1999
Editors:
Brown, F. (Greenport, N.Y.);
Lewis, Jr., A.M.; Peden, K.;
Krause, P. (Bethesda, Md.)
X + 550 p., 56 fig., 53 tab.,
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CHF 500.– / EUR 357.– / USD 435.00
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Vol. 105: Progress
in Polio Eradication:
Vaccine Strategies for
the End Game
Vol. 106
Symposium, Paris, June 2000
Editor:
Brown, F. (Greenport, N.Y.)
XII + 248 p., 43 fig., 26 tab.,
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Vol. 105
Vol. 104:
Development and
Clinical Progress of
DNA Vaccines
Symposium, Paul-Ehrlich-Institut,
Langen, Germany, October, 1999
Editors:
Brown, F. (Greenport, N.Y.);
Chichutek, K. (Langen);
Robertson, J.S. (Potters Bar)
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Vol. 103: Physico-
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Characterization of
Vaccines
Les Pensières, Veyrier-du-Lac,
France, December 1999
Editors:
Brown, F. (Greenport, N.Y.);
Corbel, M.J. (Potters Bar);
Griffiths, E. (Geneva)
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