Current concepts for the validation of compendial assays. - Pharmacopoeial Forum. The United States Pharmacopeia Inc., Rockville, 1986, p. 1241.
Validation of compendial assays. - Guidelines, Pharmacopoeial Forum, The United States Pharmacopeia Inc., Rockville, 1986, p 4129.
Note explicative III/844/87-FR. - Commission des Communautés européennes. Groupe de travail du Comité des spécialités pharmaceutiques, août 1989.
General information <1225>. - United States Pharmacopoeia XXII, The United States Pharmacopoeia Inc., Rockville, 1990, p. 1710.
CAPORAL-GAUTHIER J. AND NIVET J.M. - Guide de validation analytique. Rapport d'une commission SFSTP. - STP Pharma Prat., 2, 205-226, 1992.
LANG J.R. AND BOLTON S. - A comprehensive method validation strategy for bionalytical applications in the pharmaceutical industry. Experimental considerations. - J. Pharm. Biomed Anal., 9, 357-361, 1991
HUBERT PH., CHIAP P, AND CROMMEN J. - Validation of a bioanalytical method. - Validation course, Liège, 28 June-2 July 1993.
DADGAR D, AND SMYTH M.R. - Validation of chromatographic methods of analysis of drugs in biological samples. - Trends Anal. Chem., 5, 115-117, 1986.
METHA A C. - Drug determination in biological fluids, approach to method validation. - Talanta, 34, 609-613, 1987.
MEHTA A.C. - The validation criteria for analytical methods used in pharmaceutical practice research. - J. Clin. Pharm. Ther., 14, 465-473, 1989.
CAUSEY A.C., HILLS H.M. AND PHILLFIS L.J. - Evaluation of criteria for the acceptance of bioanalytical data. - J. Pharm. Biomed. Anal., 8, 625-628, 1990.
BUICK A.R., DOIG M.V. JEAL S.C., LAND G.S. AND MCDOWALL R.D. - Method validation in the bioanalytical laboratory. - J. Pharm. Biomed. Anal., 8, 629-637, 1990.
KARNES H.T. AND MARCH C. - Calibration and validation of linearity in chromatographic biopharmaceutical analysis. - J. Pharm. Biomed. Anal., 9, 911-918, 1991.
KARNES H T., SHIU G. AND SHAH V.P. - Validation of bioanalytical methods. - Pharm. Res , 8, 421-426, 1991.
SHAH V.P., MIDHA K K., DIGHE S., MCGILVERAY I., SKELLY J.P., YACOBI A., LAYLOFF T., VISWANATHAN C.T., COOK C.E , MCDOWALL R.D. AND PITTMAN K.A. - Analytical methods validation: bioavailability, bioequivalence, and pharmacokinetics studies. - J. Pharm. Sci., 81, 309-312, 1992.
ARNOUX P AND MORRISON R. - Drug analysis of biological samples. A survey of validation approaches in chromatography in the UK pharmaceutical industry. - Xenobiotica. 22, 757-764, 1992
KARNES H T. AND MARCH C. - Precision, accuracy and data acceptance criteria in biopharmaceutical analysis. - Pharm Res., 10, 1420-1426, 1993.
HARTMANN C., MASSART D.L. AND MCDOWALL R D. - An analysis of the Washingthon conference report on bioanalytical method validation. - J. Pharm. Biomed Anal., 12, 1337-1343, 1994
DADGAR D., BURNETT P.E., CHOC M.G , GALLICANO K. AND HOOPER J.W. - Application issues in bioanalytical method validation, sample analysis and data reporting. - J. Pharm. Biomed. Anal., 13, 89-97, 1995.
Bio-International 2. Post-conference satellite symposium, Update on analytical method validation - H H. Blume and K.K. Midha Eds., Medpharm, Stuttgart, 1995, p. 319.
Text on validation of analytical procedures: definitions and terminology (Q2A). - Tripartite International Conference on Harmonisation (ICH) text, ICH Tech coordination, London, 26 October 1994.
Validation of analytical procedure: methodology (Q2B). - Tripartite International Conference on Harmonisation text (ICH 3), ICH Tech coordination, London, 29 November 1995.
VESSMAN J. - Selectivity or specificity? Validation of analytical methods from the perspective of an analytical chemist in the pharmaceutical industry. - J. Pharm. Biomed. Anal., 14, 867-869, 1996
MASSART D.L., VANDEGINSTE B.G.M., DEMING S.N., MICHOTTE Y. AND KAUFMAN L. - Chemometrics : a textbook. - In: Data Handling in Science and Technology, Vol. 2, B.G.M. Vandeginste and L. Kaufman Eds., Elsevier, Amsterdam, 1988.
INMANN E.L., FRISCHMANN J.K., JIMENEZ P.J., WINKEL G.D., PERSINGER M.L. AND RUTHERFORD B S - General method validation guidelines for pharmaceutical samples. - J. Chromatogr Sci., 25, 252-256, 1987.
Chow S.-C. and Liu J.-P. (Eds.) - Statistical Design and Analysis in Pharmaceutical Sciences: Validation, Process Controls, and Stability. - Statistics Textbooks and Monographs. Vol. 143, Marcel Dekker, New York, 1995.
HARTMANN C., SMEYERS-VERBEKE J , PENNINCKX W., VANDER HEYDEN Y., VANKEERBERGHEN P AND MASSART D.L. - Reappraisal of hypothesis testing for method validation: detection of systematic error by comparing means of two methods or of two laboratories - Anal. Chem., 67, 4491-4499, 1995.
MILLER J.C. AND MILLER J.N. (EDS.) - Statistics for Analytical Chemistry. - 3rd edition, Ellis Horwood, New York, 1993.
NETER J., WASSERMAN W. AND KUTNER M.H. (EDS ) - Applied Linear Statistical models. - 3rd edition, Irwin, Boston, 1990.
LEVENE H. - Robust test for equality of variances. - In: Contributions to Probability and Statistics, I. Olkin, Ed., Stanford University Press, 1960, p. 278.
