Acceptable, Equivalent, or Better: Approaches for Alternatives to Official Compendial Procedures

The General Notices in the US Pharmacopeia (USP) permit analysts to use acceptable (suitable) alternativesto an official procedure. In a revision that will be effective May 1, 2009, theGeneral Notices will require that thealternative procedure be demonstrated to give results that are equivalent to or better than those obtained by theofficial procedure. This Stimuli article discusses approaches for determining equivalent or better procedures. Theconcepts and tests discussed in this paper may become one or more USP General Chapters. The preceding Stimuliarticle speaks to approaches that determine an acceptable procedure without requiring a study to documentequivalent or better.INTRODUCTIONIn its General Notices,theUS Pharmacopeia(USP)states: ‘‘Compliance may be determined also by theuse of alternative methods, chosen for advantages in ac-curacy, sensitivity, precision, selectivity, or adaptability toautomation or computerized data reduction or in otherspecial circumstances. Such alternative or automatedprocedures or methods shall be validated (1).

[1]  D. Altman,et al.  STATISTICAL METHODS FOR ASSESSING AGREEMENT BETWEEN TWO METHODS OF CLINICAL MEASUREMENT , 1986, The Lancet.

[2]  F. Xavier Rius,et al.  Multiple analytical method comparison using maximum livelihood principal component analysis and linear regression with errors in both axes , 2001 .

[3]  J O Westgard.  Points of care in using statistics in method comparison studies. , 1998, Clinical chemistry.

[4]  L M Thienpont,et al.  Validity of linear regression in method comparison studies: is it limited by the statistical model or the quality of the analytical input data? , 1998, Clinical chemistry.

[5]  C. Lao.  EQUIVALENCE IN TEST ASSAY METHOD COMPARISONS FOR THE REPEATED-MEASURE, MATCHED-PAIR DESIGN IN MEDICAL DEVICE STUDIES: STATISTICAL CONSIDERATIONS* , 2000, Journal of biopharmaceutical statistics.

[6]  Jason J. Z. Liao,et al.  An improved concordance correlation coefficient , 2003 .

[7]  S. Wellek.  Testing Statistical Hypotheses of Equivalence , 2002 .

[8]  Joseph Foss,et al.  Comparing Methods of Clinical Measurement: Reporting Standards for Bland and Altman Analysis , 2000, Anesthesia and analgesia.

[9]  Philippe Hubert,et al.  Using total error as decision criterion in analytical method transfer , 2007 .

[10]  R. Magari.  Bias Estimation in Method Comparison Studies , 2004, Journal of biopharmaceutical statistics.

[11]  Dietmar Stöckl,et al.  Application of the Bland-Altman plot for interpretation of method-comparison studies: a critical investigation of its practice. , 2002, Clinical chemistry.

[12]  J. Shao,et al.  Assessing the Agreement Between Two Quantitative Assays with Repeated Measurements , 2004, Journal of biopharmaceutical statistics.

[13]  D. Raichvarg,et al.  New statistical approach in biochemical method-comparison studies by using Westlake's procedure, and its application to continuous-flow, centrifugal analysis, and multilayer film analysis techniques. , 1983, Clinical chemistry.

[14]  Bendix Carstensen,et al.  Comparing and predicting between several methods of measurement. , 2004, Biostatistics.

[15]  Giselle Limentani,et al.  Beyond the t-test: statistical equivalence testing. , 2005, Analytical chemistry.

[16]  Douglas G. Altman,et al.  Measurement in Medicine: The Analysis of Method Comparison Studies , 1983 .

[17]  J. Shao,et al.  TESTING THE AGREEMENT OF TWO QUANTITATIVE ASSAYS IN INDIVIDUAL MEANS , 2002 .

[18]  Jason J. Z. Liao,et al.  Assessing the reproducibility of an analytical method. , 2006, Journal of chromatographic science.

[19]  W. Horwitz,et al.  INTERNATIONAL UNION OF PURE AND APPLIED CHEMISTRY ANALYTICAL CHEMISTRY DIVISION COMMISSION ON ANALYTICAL NOMENCLATURE* COMMISSION ON GENERAL ASPECTS OF ANALYTICAL CHEMISTRY' NOMENCLATURE OF INTERLABORATORY ANALYTICAL STUDIES , 2004 .

[20]  S. Walter,et al.  Sample size and optimal designs for reliability studies. , 1998, Statistics in medicine.

[21]  J. W. Lewis,et al.  A note on concordance correlation coefficient. , 2000, PDA journal of pharmaceutical science and technology.

[22]  L. Thienpont,et al.  Interpreting method comparison studies by use of the bland-altman plot: reflecting the importance of sample size by incorporating confidence limits and predefined error limits in the graphic. , 2004, Clinical chemistry.

[23]  H. Wätzig,et al.  Application of the equivalence test for analytical method transfers: testing precision using the United States Pharmacopoeia concept (1010). , 2006, Journal of pharmaceutical and biomedical analysis.

[24]  D. Altman,et al.  Measuring agreement in method comparison studies , 1999, Statistical methods in medical research.

[25]  Y. Heyden,et al.  Statistical method comparison: short- and long-column liquid chromatography assays of ketoconazole and formaldehyde in shampoo , 2004 .

[26]  Donald J. Schuirmann.  A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability , 1987, Journal of Pharmacokinetics and Biopharmaceutics.

[27]  L. Lin,et al.  A concordance correlation coefficient to evaluate reproducibility. , 1989, Biometrics.

[28]  David Hoffman,et al.  A Total Error Approach for the Validation of Quantitative Analytical Methods , 2007, Pharmaceutical Research.

[29]  K. Rick Lung,et al.  Statistical method for the determination of equivalence of automated test procedures , 2003, Journal of automated methods & management in chemistry.

[30]  Christophe Agut,et al.  A Unified Approach for Design and Analysis of Transfer Studies for Analytical Methods , 2001 .

[31]  J. Shao,et al.  Evaluating the Agreement of Two Quantitative Assays with Repeated Measurements , 2003, Journal of biopharmaceutical statistics.

[32]  H. Wätzig,et al.  Application of the equivalence test according to a concept for analytical method transfers from the International Society for Pharmaceutical Engineering (ISPE). , 2005, Journal of pharmaceutical and biomedical analysis.

[33]  B. Iglewicz,et al.  Measurement-methods comparisions and linear statistical relationship , 1999 .

[34]  P H Petersen,et al.  Graphical interpretation of analytical data from comparison of a field method with reference method by use of difference plots. , 1997, Clinical chemistry.

[35]  R F Martin,et al.  General deming regression for estimating systematic bias and its confidence interval in method-comparison studies. , 2000, Clinical chemistry.

[36]  Don Chambers,et al.  Analytical method equivalency: An acceptable analytical practice , 2005 .

[37]  Theo Gasser,et al.  Assessing intrarater, interrater and test–retest reliability of continuous measurements , 2002, Statistics in medicine.