Summary
Three methods of analysing data obtained from bioavailability studies are compared using concentration-time curves derived from measurements of clofibrinic acid in plasma. These methods are the analysis of variance of rate constants obtained from fitting a two compartmental model to the concentration-time curves; the analysis of variances of characteristics of the concentration-time curves namely, the areas under the curves the peak concentrations and the times taken after dosing to reach these peak concentrations; and the split-plot analysis of variance carried out on the individual concentration values. The second method of analysis is found to be the most satisfactory for routine use. Caution is required in the interpretation of the results of the split plot analysis in particular, the comparisons of the mean plasma concentrations.
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References
Westlake W.J. (1973): Use of statistical methods in evaluation of in vivo performance of dosage forms, J. Pharm. Sci.,62, 1579–1589.
Westlake W.J. (1974): The use of balanced incomplete block design in comparative bioavailability trials, Biometrics,30, 319–327.
Metzler C.M. (1974): Bioavailability — a problem in equivalence, Biometrics,30, 309–317.
Saunders L. and Natunen T. (1973): A stable method for calculating oral drug absorption rate constants with two compartment disposition J. Pharm. Sci.,25, Suppl., 44–51.
Taylor T. and Chasseaud L.F. (1977): Plasma concentrations and bioavailability of p-chlorophenoxyisobutyric acid (clofibrinic acid) from its calcium salt in humans, J. Pharm. Sci.,66, 1638–1639.
Crouthamel W.G. and Canedella R.J. (1975): Clofibrate Pharmacokinetics: effect of elevation of plasma-free fatty acids, Pharmacology,13, 465–473. or](7) Unwin P.F. (1976): Bioavailability Studies. Unpublished thesis for the diploma in statistics at the University of Cambridge.
Box G.E.P. (1950): Analysis of growth and wear curves, Biometrics,6, 362–389.
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Shirley, E.A.C., Unwin, P.F. The analysis of data from comparative bioavailability studies. European Journal of Drug Metabolism and Pharmacokinetics 3, 165–170 (1978). https://doi.org/10.1007/BF03189502
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DOI: https://doi.org/10.1007/BF03189502