Equivalence Testing for Parallelism in the Four-Parameter Logistic Model

REFERENCES

• Anderson , S. , Hauck , W. W. ( 1983 ). A new procedure for testing equivalence in comparative bioavailability and other clinical trials . Commun. Statist. Theory Methods 12 : 2663 – 2692 .
   Web of Science ®Google Scholar
• Berger , R. L. ( 1982 ). Multiparameter hypothesis testing and acceptance sampling . Technometrics 24 : 295 – 300 .
   Web of Science ®Google Scholar
• Berger , R. L. , Hsu , J. C. ( 1996 ). Bioequivalence trials, intersection-union tests, and equivalence confidence sets . Statist. Sci. 11 : 283 – 319 .
   Web of Science ®Google Scholar
• Callahan , J. D. , Sajjadi , N. C. ( 2003 ). Testing the null hypothesis for a specified difference – the right way to test for parallelism . BioProcessing J. March/April : 71 – 77 .
   Google Scholar
• Casella , G. , Berger , R. L. ( 1990 ). Statistical Inference . Belmont , CA : Duxbury Press .
   Google Scholar
• Ding , J. , Bailey , M. ( 2003 ). Analyzing dose-response curves in JMP . JMPer Cable 12 : 1 – 6 .
   Google Scholar
• Finney , D. J. ( 1976 ). Radioligand assay . Biometrics 32 : 721 – 740 .
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration . ( 1992 ). Bioavailability and bioequivalence requirements . In: U.S. Code of Federal Regulations , Vol. 21 , Chapter 320 . Washington , DC : U.S. Government Printing Office .
   Google Scholar
• Gallant , A. R. ( 1987 ). Nonlinear Statistical Models . New York : Wiley .
   Google Scholar
• Gottschalk , P. G. , Dunn , J. R. ( 2005 ). Measuring parallelism, linearity, and relative potency in bioassay and immunoassay data . J. Biopharm. Statist. 15 : 437 – 463 .
   PubMed Web of Science ®Google Scholar
• Hauck , W. W. , Capen , R. C. , Callahan , J. D. , De Muth , J. E. , Hsu , H. , Lansky , D. , Sajjadi , N. C. , Seaver , S. S. , Singer , R. H. , Weisman , D. ( 2005 ). Assessing parallelism prior to determining relative potency . PDA J. Pharm. Sci. Technol. 59 : 127 – 137 .
   PubMedGoogle Scholar
• Hauck , W. W. , Singer , R. , Callahan , L. N. ( 2007 ). Summary of planned revisions to Design and Analysis of Biological Assays ⟨111⟩ . Pharm. Forum 33 : 580 – 581 .
   Google Scholar
• Hougaard , P. ( 1985 ). The appropriateness of the asymptotic distribution in a nonlinear regression model in relation to curvature . J. Roy. Statist. Soc., Ser. B Statist. Methodol. 47 : 103 – 114 .
   Web of Science ®Google Scholar
• Kpamegan , E. P. ( 2005 ). A comparative study of statistical methods to assess dilutional similarity . BioPharm Inter. 18 ( 10 ): 60 – 63 .
   Web of Science ®Google Scholar
• Kutner , M. H. , Nachtsheim , C. J. , Neter , J. , Li , W. ( 2004 ). Applied Linear Statistical Models . New York : McGraw-Hill/Irwin .
   Google Scholar
• O'Connell , M. A. , Belanger , B. A. , Haaland , P. D. (1993). Calibration and assay development using the four-parameter logistic model. Chemometrics Intelligent Lab. Sys. 20:97–114.
   Web of Science ®Google Scholar
• Plikaytis , B. D. , Holder , P. F. , Pais , L. B. , Maslanka , S. E. , Gheesling , L. L. , Carlone , G. M. ( 1994 ). Determination of parallelism and nonparallelism in bioassay dilution curves . J. Clin. Microbiol. 32 : 2441 – 2447 .
   PubMed Web of Science ®Google Scholar
• R Development Core Team . ( 2007 ). R: A Language and Environment for Statistical Computing . Vienna : R Foundation for Statistical Computing .
   Google Scholar
• Rawlings , J. O. , Pantula , S. G. , Dickey , D. A. ( 1998 ). Applied Regression Analysis: A Research Tool . New York : Springer-Verlag .
   Google Scholar
• Reeve , R. ( 2000 ). Two statistical methods for estimating relative potency of bioassays . BioPharm 13 : 54 – 60 .
   Google Scholar
• Sasabuchi , S. ( 1980 ). A test of a multivariate normal mean with composite hypotheses determined by linear inequalities . Biometrika 67 : 429 – 439 .
   Web of Science ®Google Scholar
• Schuirmann , D. L. ( 1981 ). On hypothesis testing to determine if the mean of a normal distribution is contained in a known interval . Biometrics 37 : 617 .
   Web of Science ®Google Scholar
• Westlake , W. J. ( 1981 ). Response to T. B. L. Kirkwood: Bioequivalence testing—A need to rethink . Biometrics 37 : 589 – 594 .
   Web of Science ®Google Scholar