Analytical goals for determinations of theophylline concentration in serum. 1991

R W Jenny
Wadsworth Center for Laboratories and Research, New York State Department of Health, Albany 12201-0509.

Statistical principles for analytical goal-setting were applied to two medical applications of drug-monitoring data: (a) individualizing dosage requirements by reference to a population-based therapeutic range or to a patient-specific decision value determined by Bayesian decision analysis, and (b) prospective dosing by using pharmaco-kinetic principles. For application a, the analytical goal for total allowable analytical error (TE) was defined as the amount of error that does not decrease by more than 5% either the sensitivity (probability) for detecting dosage regimens that may require modification or the specificity for detecting appropriately dosed patients. The limiting factor in achievable sensitivity and specificity was the intra-individual variation of peak steady-state concentration (Css), with the TE determined to be a CV of 4%. For application b, error-propagation rules were applied to a proposed prospective dosing scheme (J Pharmacokinet Biopharm 1978;6:135-51). The TE was determined to depend on the rate of theophylline clearance. For clearance rates less than or equal to 0.6 mL/(kg.min), the TE (CV) must not exceed 3% if the predicted infusion rate is to produce, with 95% confidence, a concentration within the therapeutic range.

UI MeSH Term Description Entries
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012680 Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed) Specificity,Sensitivity,Specificity and Sensitivity
D013806 Theophylline A methyl xanthine derivative from tea with diuretic, smooth muscle relaxant, bronchial dilation, cardiac and central nervous system stimulant activities. Theophylline inhibits the 3',5'-CYCLIC NUCLEOTIDE PHOSPHODIESTERASE that degrades CYCLIC AMP thus potentiates the actions of agents that act through ADENYLYL CYCLASES and cyclic AMP. 1,3-Dimethylxanthine,3,7-Dihydro-1,3-dimethyl-1H-purine-2,6-dione,Accurbron,Aerobin,Aerolate,Afonilum Retard,Aquaphyllin,Armophylline,Bronchoparat,Bronkodyl,Constant-T,Elixophyllin,Euphylong,Glycine Theophyllinate,Lodrane,Monospan,Nuelin,Nuelin S.A.,Quibron T-SR,Slo-Phyllin,Somophyllin-T,Sustaire,Synophylate,Theo Von Ct,Theo-24,Theo-Dur,Theobid,Theocin,Theoconfin Continuous,Theodur,Theolair,Theolix,Theon,Theonite,Theopek,Theophylline Anhydrous,Theophylline Sodium Glycinate,Theospan,Theostat,Theovent,Uniphyl,Uniphyllin,Uniphylline,1,3 Dimethylxanthine,Anhydrous, Theophylline,Constant T,ConstantT,Ct, Theo Von,Glycinate, Theophylline Sodium,Quibron T SR,Quibron TSR,Slo Phyllin,SloPhyllin,Sodium Glycinate, Theophylline,Somophyllin T,SomophyllinT,Theo 24,Theo Dur,Theo24,Theophyllinate, Glycine,Von Ct, Theo

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