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  • 1
    Electronic Resource
    Electronic Resource
    SEX DIFFERENCES IN PHARMACOKINETICS AND PHARMACODYNAMICS (2004)
    Palo Alto, Calif. : Annual Reviews
    Annual Review of Pharmacology 44 (2004), S. 499-523 
    Details
    ISSN: 0362-1642
    Source: Annual Reviews Electronic Back Volume Collection 1932-2001ff
    Topics: Medicine , Chemistry and Pharmacology
    Notes: The importance of reviewing and studying sex-based differences in pharmacologic parameters is demonstrated by the increasing data on gender variation in drug efficacy and toxicity profiles. Sex-based differences in the four major factors that contribute to interindividual pharmacokinetic variability-bioavailability, distribution, metabolism, and elimination-are theorized to stem from variations between men and women in factors such as body weight, plasma volume, gastric emptying time, plasma protein levels, cytochrome P450 activity, drug transporter function, and excretion activity. Sex-determined variations in pharmacodynamics have traditionally been more difficult to study, but a number of recent studies have explored these differences. This review examines the biologic basis of differences in pharmacokinetics and pharmacodynamics between the sexes and summarizes studies that have addressed these differences. As an example, sex-based variation in the efficacy and toxicity of antiretroviral therapy in human immunodeficiency virus (HIV)-infected patients is explored more thoroughly to illustrate some of the factors underlying sex-based differences in drug therapy.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1146/annurev.pharmtox.44.101802.121453
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  • 2
    Electronic Resource
    Electronic Resource
    Synthesis and anticholinergic properties of the enantiomers of 4-(isopropylamino)-2-(2-pyridyl)-2-phenylbutyramide, the mono-N-dealkylated metabolite of disopyramide (1981)
    s.l. : American Chemical Society
    Journal of medicinal chemistry 24 (1981), S. 614-617 
    Details
    ISSN: 1520-4804
    Source: ACS Legacy Archives
    Topics: Chemistry and Pharmacology
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1021/jm00137a024
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  • 3
    Electronic Resource
    Electronic Resource
    A Semiparametric Method for Describing Noisy Population Pharmacokinetic Data (1997)
    Springer
    Journal of pharmacokinetics and pharmacodynamics 25 (1997), S. 615-642 
    Details
    ISSN: 1573-8744
    Keywords: semiparametric ; population pharmacokinetics ; mixed-effects model ; random-effects ; longitudinal spline ; nonparametric
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract We propose a semiparametric method to estimate model-independent pharmacokinetic (PK) measures such as area under concentration–time, peak concentration and time to peak concentration (Tpeak ), for noisy population PK data from a sparsely sampled prospectively designed trial. The method is developed within the mixed-effect model framework, for the single-dose and steady-state case. We describe individual concentration vs. time using a longitudinal spline, consisting of a template spline, common to all individuals, and an individual-specific distortion spline accounting for individual differences. We impose a number of constraints on the longitudinal spline, including (i) it has a decreasing tail, (ii) its typical Tpeak is near the modal Tpeak observed in the population data, and (iii) its value is zero at time zero (single dose), or the same nonzero value at the beginning and end of a dosing interval (steady state). We test our method using simulated data and compare its performance to that of a parametric and a nonparametric method. An actual data example is also shown. The performance of the method is as good or better than that of a standard nonparametric method, and when the analysis model is misspecified, the method is superior to a standard parametric one. Since it is often not apparent that an analysis model is correct, we propose this approach as a general method for analysis.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1025769431364
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  • 4
    Electronic Resource
    Electronic Resource
    Probenecid inhibition of methotrexate excretion from cerebrospinal fluid in dogs (1978)
    Springer
    Journal of pharmacokinetics and pharmacodynamics 6 (1978), S. 389-397 
    Details
    ISSN: 1573-8744
    Keywords: probenecid ; methotrexate ; cerebrospinal fluid ; kinetics ; interaction ; dogs ; choroid plexus ; intrathecal
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Probenecid is known to inhibit the renal excretion of methotrexate (MTX) and the transport of organic anions by the choroid plexus of the brain. The effect of probenecid on the CSF clearance of MTX given by the intrathecal route was examined in anesthetized dogs. Plasma and CSF MTX levels were measured following intrathecal injection of 0.4 mg/kg MTX, with and without pretreatment with probenecid. In the absence of probenecid, the peak plasma MTX concentration of 3.18×10−7±1.09×10−7 M (mean±SD) was reached 5 hr after intrathecal injection. With probenecid pretreatment, the mean peak plasma MTX concentration was lower (2.09×10−7+-0.98×10−7 M) and plasma disappearance was prolonged. A biexponential decay of CSF MTX levels was observed over the duration of sampling. The half-life of the second exponential phase was 21 hr without probenecid pretreatment and was longer after probenecid pretreatment. These results provide strong evidence that probenecid inhibits transfer of MTX from CSF to plasma following intrathecal injection.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01062721
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  • 5
    Electronic Resource
    Electronic Resource
    Optimizing the Science of Drug Development: Opportunities for Better Candidate Selection and Accelerated Evaluation in Humans (2000)
    Springer
    Pharmaceutical research 17 (2000), S. 1335-1344 
    Details
    ISSN: 1573-904X
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1007574217260
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  • 6
    Electronic Resource
    Electronic Resource
    Stereoselective Binding of Disopyramide to Plasma Proteins (1988)
    Springer
    Pharmaceutical research 5 (1988), S. 316-318 
    Details
    ISSN: 1573-904X
    Keywords: disopyramide ; pharmacokinetics ; plasma proteins ; stereoisomers
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1023/A:1015986906627
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  • 7
    Electronic Resource
    Electronic Resource
    The effect of saturable binding to plasma proteins on the pharmacokinetic properties of disopyramide (1982)
    Springer
    Journal of pharmacokinetics and pharmacodynamics 10 (1982), S. 1-14 
    Details
    ISSN: 1573-8744
    Keywords: disopyramide ; pharmacokinetics ; antiarrhythmic, healthy subjects
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Disopyramide exhibits saturable binding to plasma proteins in the therapeutic plasma concentration range. Because of this property, controversy exists in the literature regarding the pharmacokinetic properties of the drug. The purposes of this study were to reassess the pharmacokinetic properties of disopyramide in humans, taking into consideration both total and unbound concentrations and to use disopyramide as a model compound to study the effect of drug binding on the renal clearance of both total and unbound drug. A single intravenous dose of disopyramide (1.5 mg/kg) was administered to eight normal volunteers. Blood and urine samples were collected for 36h. Total concentrations of disopyramide in plasma and urine were determined by high pressure liquid chromatography. Binding of disopyramide to plasma proteins was determined by equilibrium dialysis. In all subjects, the binding of disopyramide to plasma proteins was saturable, but there were considerable differences in binding between subjects. The volume of distribution, total body clearance, and renal clearances of both total and unbound drug were calculated. Because only the total body clearance and renal clearance of unbound compound are not dependent upon unbound fraction (α), these are the only parameters which can be reported without qualification as to the concentration. The mean ± SD total body clearance of unbound drug in the eight subjects was 5.40± 2.80 ml/min/kg. About 50% of this was due to renal elimination. A statistically significant negative correlation of the renal clearance of total disopyramide with time was observed in seven of eight subjects, whereas a significant correlation between the renal clearance of unbound disopyramide and time was observed in only one subject. This suggests that the renal clearance of unbound disopyramide is independent of α, while the renal clearance of total disopyramide is dependent upon α.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01059180
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  • 8
    Electronic Resource
    Electronic Resource
    Interaction of clofibrate with warfarin. I. Effect of clofibrate on the disposition of the optical enantiomorphs of warfarin (1977)
    Springer
    Journal of pharmacokinetics and pharmacodynamics 5 (1977), S. 495-505 
    Details
    ISSN: 1573-8744
    Keywords: warfarin ; clofibrate ; drug interactions
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Four volunteers each received single oral doses of the R and S enantiomorphs of warfarin on separate occasions, both before and during clofibrate coadministration. Three of the subjects showed evidence for a drug interaction as manifested by an increase in the hypoprothrombinemic response to the S enantiomorph during clofibrate coadministration (0.10〉p〉0.05). No changes were observed in the response to the R enantiomorph. The volume of distribution of the R enantiomorph was increased (0.01〉p〉 0.005), as was the plasma clearance (0.10〉p〉 0.05), in all four subjects during clofibrate coadministration. No significant changes were found in the volume of distribution or clearance of the S enantiomorph. This study indicates that differential changes in the clearance of the enantiomorphs of warfarin are not the mechanism responsible for the interaction of clofibrate with warfarin. Although the results indicate that plasma protein displacement of warfarin occurs in vivo,it can be concluded that the mechanism underlying the long-term enhanced hypoprothrombinemic effect of warfarin in the presence of clofibrate is of a pharmacodynamic nature.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01061730
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  • 9
    Electronic Resource
    Electronic Resource
    In vivo interaction of the enantiomers of disopyramide in human subjects (1986)
    Springer
    Journal of pharmacokinetics and pharmacodynamics 14 (1986), S. 335-356 
    Details
    ISSN: 1573-8744
    Keywords: disopyramide ; pharmacokinetics ; stereoisomers ; antiarrhythmic agents
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Disopyramide, an antiarrhythmic agent, is marketed as a racemic mixture of two enantiomers. The racemic drug has unusual pharmacokinetic properties because of its concentration-dependent binding to plasma proteins in the therapeutic plasma concentration range. This study examined, in healthy subjects, the individual pharmacokinetic properties of both total and unbound d-and ldisopyramide in plasma after intravenous administration of each enantiomer separately (1.5mg/kg).Also investigated is the pharmacokinetics of total d-and l-disopyramide in plasma after intravenous administration of a pseudoracemate. Both d-and l-disopyramide are found to exhibit concentration-dependent binding to plasma proteins, with d-disopyramide being more avidly bound at lower concentrations. The stereoselective, concentration-dependent binding to plasma proteins resulted in distinct pharmacokinetic properties when the enantiomers were given together as the pseudoracemate. d-Disopyramide had a lower plasma clearance and renal clearance, a longer half-life, and a smaller apparent volume of distribution than l-disopyramide. However, when the enantiomers were administered separately, there were no differences in the clearance, renal clearance, and volume of distribution between enantiomers calculated from either total or unbound drug concentrations. The results reveal an important pharmacokinetic interaction between the enantiomers of disopyramide when given as a racemic mixture, which may be dose-dependent and is not apparent upon administration of the enantiomers separately.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF01059195
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  • 10
    Electronic Resource
    Electronic Resource
    Do we need full compliance data for population pharmacokinetic analysis? (1996)
    Springer
    Journal of pharmacokinetics and pharmacodynamics 24 (1996), S. 265-282 
    Details
    ISSN: 1573-8744
    Keywords: compliance ; MEMS ; population pharmacokinetics ; Markov chain model
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract For population pharmacokinetic analysis of multiple oral doses one of the key issues is knowing as precisely as possible the dose inputs in order to fit a model to the input-output (dose-concentration) relationship. Recently developed electronic monitoring devices, placed on pill containers, permit precise records to be obtained over months, of the time/date opening of the container. Such records are reported to be the most reliable measurement of drug taking behavior for ambulatory patients. To investigate strategies for using and summarizing this new abundant information, a Markov chain process model was developed, that simulates compliance data from real data from electronically monitored patients, and data simulations and analyses were conducted. Results indicate that traditional population pharmacokinetic analysis methods that ignore actual dosing information tend to estimate biased clearance and volume and markedly overestimate random interindividual variability. The best dosing information summarization strategies consist of initially estimating population pharmacokinetic parameters, using no covariates and only a limited number of dose records, the latter chosen based on an a priori estimate of the half-life of the drug in the compartment of interest; then resummarizing the dose records using either population or individual posterior Bayes parameter estimates from the first population fit; and finally reestimating the population parameters using the newly summarized dose records. Such summarization strategies yield the same parameter estimates as using full dosing information records while reducing by at least 75% the CPU time needed for a population pharmacokinetic analysis.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF02353671
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