Methods for the Design and Analysis of Replicate-Experiment Studies to Establish Assay Reproducibility and the Equivalence of Two Potency Assays

Drug Discovery Handbook

Volumn , Issue , 2005, Pages 667-688

  Eastwood, Brian J ^a   Chesterfield, Amy K ^a   Wolff, Mary C ^a   Felder, Christian C ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

Assay reproducibility; Concentration response assay; Replicate experiment protocol

Indexed keywords

EID: 33646242701     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/0471728780.ch15     Document Type: Chapter

References (17)

1. Sittampalam, G. S., Iversen, P. W., Boadt, J. A., Kahl, S. D., Bright, S., Zock, J. M., Janzen,W. P., Lister, M. D. (1997). Design of signal windows in high throughput screening assays for drug discovery. J. Biomol. Screen., 2, 159-169.
2. Zhang, J.-H., Chung, T. D. Y., Oldenburg, K. R. (1999). A simple statistical parameter for use in evaluation and validation of high throughput screening assays. J. Biomol. Screen., 4, 67-73.
3. Taylor, P. B., Stewart, F. P., Dunnington, D. J., Quinn, S.T., Schulz, C. K.,Vaidya, K. S., Kurali, E., Tonia, R. L., Xiong,W. C., Sherrill, T. P., Snider, J. S., Terpstra, N. D., Hertzberg, R. P. (2000). Automated assay optimization with integrated statistics and smart robotics. J. Biomol. Screen., 5, 213-225.
4. Eastwood, B. J., Farmen, M. W., Iversen, P. W, Craft, T. J., Smallwood, J. K., Garbison, K. E., Delapp, N. W., Smith, G. F. (Submitted for publication). The minimum significant ratio: A statistical parameter to characterize the reproducibility of potency estimates from concentration-response assays. J. Biomol. Screen.
5. Kenakin, T. (1997). Pharmacologic Analysis of Drug-Receptor Interaction, 3rd ed. Lippencott-Raven, Philadelphia, pp. 242-289.
6. Molulsky, H., Christopoulos, A. (2003). Fitting Models to Biological Data Using Linear and Nonlinear Regression: A Practical Guide to Curvefitting. Graphpad Software, San Diego, CA, pp. 259-260.
7. Ratkowsky, D. A., Reedy, T. J. (1986). Choosing near-linear parameters in the four-parameter logistic model for radioligand and related assays. Biometrics, 42, 575-582.
8. Gallant, A. R. (1987). Nonlinear Statistical Models.Wiley, New York, pp. 16-18.
9. Serfling, R. J. (1980). Approximation Theorems in Mathematical Statistics. Wiley, New York, p. 33.
10. DeLapp,N.W., McKinzie, J. H., Sawyer, B. D.,Vandergriff, A., Falcone, J., McClure, D., Felder, C. C. (1999). Determination of [35S] guanosine-5¢-O-(3-thio) triphosphate binding mediated by cholinergic muscarinic receptors in membranes from Chinese hamster ovary cells and rat striatum using an anti-G protein scintillation proximity assay. J. Pharmacol. Exper. Therapeut., 289(2), 946-955.
11. Motulsky, H. (2003). Graphpad/Prism® User's Guide, Version 4. Graphpad Software, San Diego, CA.
12. Bishop,Y. M. M., Feinberg, S. E., Holland, P.W. (1975). Discrete Multivariate Analysis: Theory and Practice. MIT Press, Cambridge, MA, pp. 486-487.
13. Bland, J. M., Altman, D. G. (1986). Statistical methods for assessing agreement between two methods of clinical measurement. Lancet, I, 307-310.
14. Carrasco, J. L., Jover, L. (2003). Estimating the generalized concordance correlation coefficient through variance components. Biometrics, 59, 849-858.
15. Eastwood, B. J. (2001). Comparing two measurement devices: Review and extensions to estimate new device variability. Computing Science and Statistics, 33, 462-471.
16. SAS Institute (1999). SAS ® Language Reference: Dictionary, Version 8. SAS Institute, Cary, NC, pp. 226-626.
17. SAS Institute (1999). SAS/GRAPH® Software: Reference, Version 8. SAS Institute, Cary, NC, pp. 801-859.