Bioequivalence and Bioavailability Forum

Time-warp, 20 years back...

Bubert H. und R. Klockenkämper, Fresenius Z Anal Chem, 316 (1983) 186, "Precision-Dependent Calibration in Instrumental Analysis"

Buick A.R., M.V. Doig, S.C. Jeal, G.S. Land und R.D. McDowall, J Pharm Biomed Anal, 8 (1990) 629, "Method Validation in the bioanalytical laboratory"

Causey A.G., H.M. Hills und L.J. Phillips, J Pharm Biomed Anal, 8 (1990) 625, "Evaluation of criteria for the acceptance of bioanalytical data"

Garden J.S., D.G. Mitchell und W.N. Mills, Anal Chem, 52 (1980) 2310, "Nonconstant Variance Regression Techniques for Calibration-Curve-Based Analysis"

Karnes T.H., G. Shiu und V.P. Shah, Pharm Res, 8 (1991) 421, "Validation of Bioanalytical Methods"

Karnes H.T. und C. March, J Pharm Biomed Anal, 9 (1991a) 911, "Calibration and validation of linearity in chromatographic biopharmaceutical analysis"

Lang J.R. und S. Bolton, J Pharm Biomed Anal, 9 (1991a) 435, "A comprehensive method validation strategy for bioanalytical applications in the pharmaceutical industry - 2. Statistical analyses"

Levie R. de, J Chem Educ, 63 (1986) 10, "When, Why and How to Use Weighted Least Squares"

McLean A.M., D.A. Ruggirello, C. Banfield, M.A. Gonzalez und M. Bialer, J Pharm Sci, 79 (1990) 1005, "Application of a Variance-Stabilizing Transformation Approach to Linear Regression of Calibration Lines"

Sands D.E., J Chem Educ, 51 (1974) 473, "Weighting Factors in Least Squares"

Shah V.P., K.K. Midha, S. Dighe, I.J. McGilveray, J.P. Skelly, A. Yacobi, T. Layloff, C.T. Viswanathan, C.E. Cook, R.D. McDowall, K.A. Pittmann und S. Spector, J Pharm Sci, 81 (1992) 309, "Analytical Method Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies"

...if your German is good I can provide you some text on this issue, too...