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Computer-aided dosage form design. I. Methods for defining a long-acting first-order delivery system of maximum formulating flexibility.
Pharm Res
August 1987
Stuart Pharmaceuticals, Division of ICI Americas Inc., Wilmington, Delaware 19897.
The method provides an a priori assessment of the maximum allowable flexibility in the rate of release from a prolonged-release formulation. The clinical pharmacokinetic parameters describing the drug candidate are employed to calculate the ranges of rate constants and doses required for the formulation to provide a selected therapeutic duration. For a given patient, there may be an infinite number of combinations of release rate constants and dose sizes which will maintain steady-state plasma drug concentrations within a desired range when the formulation is administered at the selected dosing interval.
View Article and Find Full Text PDFThe clinical pharmacodynamics of theophylline, which concerns the correlation between the serum theophylline concentration ([TH]) attained during therapy for asthma and improved pulmonary function or unwanted side effects, serves to link the pharmacokinetics of theophylline with the time course of clinical outcome. Although the minimum effective and maximum safe [TH]s have been known for some years, it was only recently shown that maximal improvement in pulmonary function lags behind rapidly changing [TH]s and that improved pulmonary function relates to increasing [TH]s within the therapeutic range. While much is known about the determinants of theophylline disposition in patients with asthma, enabling individualized pharmacokinetically based therapy, it is difficult to predict the clinical pharmacodynamic outcome.
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