Bioassay Resources

Select Publications and Statistical Modules

  • Lansky, D. (2002) Strip-Plot Designs, Mixed Models, and Comparison  between Linear and Non-Linear Models for Microtitre Plate Bioassays, in: Brown, F., Mire-Sluis, A. (eds) The Design and Analysis of Potency Assays for Biotechnology Products. Dev. Biol., Basel, Karger 107
  • Lansky, D. (1999) Validation of Bioassays for Quality Control, in: Brown, F., Mire-Sluis, A.R. (eds): Biological Characterization and Assay of Cytokines and Growth Factors. Dev. Biol. Stand., Basel, Karger 97:157-168
  • Variance Components (PDF)
    Bioassay Glossary (PDF)
    Bioassay Glossary reprinted with permission. Copyright 2006 United States Pharmacopeia. All rights reserved.
  • The following blog by Dan Joelsson is interesting and informative: http://www.potencyassay.com

Suggested Readings on Bioassay

  • Callahan, Janice D. and Sajjadi, Nancy C. (2003) Testing the Null Hypothesis for a Specified Difference - The Right Way to Test for Parallelism, Bioprocessing Journal Mar/Apr 1-6.
  • De Lean, A., Munson, P. J. and Rodbard, D. (1978) Simultaneous analysis of families of sigmoidal curves: applications to bioassay, radioligand assay, and physiological dose response curves, American Journal of Physiology 235(2):E97-E102.
  • Davidian, M. and Giltinan, D.M. (1995) Nonlinear Models for Repeated Measurement Data,  London:  Chapman and Hall.
  • Dillard, R.F. (2002) Statistical Approaches to Specification Setting with Application to Bioassay, in: Brown, F., Mire-Sluis, A. (eds) The Design and Analysis of Potency Assays for Biotechnology Products. Developments in Biological Standards, Basel:  Karger 107:117-127.
  • Draper, N.R. and Smith, H. (1981) Applied Regression Analysis (2nd Edition), Wiley:  NY.
  • Federer, Walter T. (1955) Experimental Design, Oxford and IBH Publishing Co., Calcutta, India.
  • Finney, David J. (1978) Statistical Method in Biological Assay (3rd Edition), London: Charles Griffin & Co. Ltd..
  • Gaines Das, R.E. (1992) Validity of Assays for Biological Products, BIRA Journal 10(8):8-13.
  • Gaines Das, R.E. and Rice, L.R. (1985) SCAN, an exploratory program for preliminary analysis of bioassay and immunoassay data, Computer Methods and Programs in Biomedicine 21:25-33.
  • Gaines Das, Rose E. and Tydeman, Michael S. (1980) Iterative weighted regression analysis of logit responses A computer program for analysis of bioassays and immunoassays, Computer programs in Biomedicine  15:13-22.
  • Giltinan, David M. and Davidian, Marie (1994) Assays for recombinant proteins: a problem in non-linear calibration, Statistics in Medicine 13:1165-1179.
  • Hauck et al., PDA Journal of Pharmaceutical Science and Technology 59(2): 127-137 (2005)
  • Higgins, K. M., Davidian, M., Chew, G., and Burge, H. (1998) The effect of serial dilution error on calibration inference in immunoassay, Biometrics 54(1) 19-32.
  • Hurlbert, Stuart H. (1984) Pseudo replication and the Design of  Ecological Field Experiments, Ecological Monographs 54(2):187-211.
  • Lansky, D. (2002) Strip-Plot Designs, Mixed Models, and Comparison between Linear and Non-Linear Models for Microtitre Plate Bioassays, in: Brown, F., Mire-Sluis, A. (eds) The Design and Analysis of Potency Assays for Biotechnology Products.  Devolopment of Biological Standards, Basel:  Karger 107.
  • Lansky, D. (1999) Validation of Bioassays for Quality Control, in: Brown, F., Mire-Sluis,A.R. (eds): Biological Characterization and Assay of Cytokines and Growth Factors. Development of Biological Standards,  Basel:  Karger 97:157-168.
  • Linstrom, M.J. and Bates, D.M (1990) Nonlinear mixed effects models for repeated measures data, Biometrics 46:673-687.
  • Littel, R.C., Milliken, G.A., Stroup, W.W. and Wolfinger, R.D. (1996) SAS System for Mixed Models, Cary, NC: SAS Institute.
  • Milliken, G.A. and Johnson, D. E. (1992) Analysis of Messy Data, Volume I: Designed Experiments, NY: Chapman and Hall.
  • Mire-Sluis, A.R., Gerrard, T., Das, R.G., Padilla, A., and Thorpe, R. (1996) Biological Assays: Their Role in the Development and Quality Control of Recombinant Biological Medicinal Products, Biologicals 24:351-362.
  • Montgomery, D.C. (2001) Design and Analysis of Experiments (5th Edition), NY: Wiley.
  • Neter, J., Wasserman, W. and Kutner, M.H. (1985) Applied Linear Statistical Models, Regression, Analysis of Variance, and Experimental Design, (2nd Edition), Richard. D. Irwin, Homewood, IL.
  • O'Connell, M.A., Belanger, B.A., and Haaland, P.D. (1993) Calibration and assay development using the four-parameter logistic model, Chemometrics and Intelligent Laboratory Systems 20:97-114.
  • Plikaytis, Brian D., Holder, Patricia F., Pais, Lorna B. Maslanka, Susan E., Gheesling, Linda L., and Carlone, George M. (1994) Determination of Parallelism and Nonparallelism in Bioassay Dilution Curves, Journal of Clinical Microbiology 32(10):2441-2447.
  • Searle, S.R., Casella, G. and McCulloch, C.E. (1992) Variance Components, Wiley, NY.
  • Schofield, Timothy (2000) Assay Validation, in Chow, Shein-Chung (ed) Encyclopedia of Biopharmaceutical Statistics, Marcel Dekker, NY 21-30.
  • Snedecor, G.W. and Cochran, W.G. (1980) Statistical Methods, 7th edition, Iowa State University Press.