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Objectives: The If channel blocker cilobradine belongs to a class of bradycardic agents selectively decreasing heart rate by reducing the diastolic depolarisation rate in the sinus node. Hence, cilobradine might be beneficial in the treatment of cardiovascular diseases, e.g. ischemia. The objective of this study was to evaluate the population pharmacokinetic PopPK ; characteristics based on data of 6 clinical phase I trials with different formulations and to assess the predictive performance of the model developed. Methods: Single doses of 1.25-40 mg cilobradine were administered as p.o. solution, p.o. capsule or 20 min i.v. infusion. The capsule was also given once daily 0.6-20 mg ; for 7 or 15 days. PK profiles of 162 males with 2733 plasma samples were analysed development data set ; . NONMEM, version V, level 1.1, with the FOCE interaction method was used for data fitting and assessment of several covariates by forward inclusion and backward deletion techniques. Model evaluation was performed using a new data set evaluation data set ; including 1713 plasma concentrations of p.o. solution over a dose range of 0.25-5 mg. Results: The data were best described by a 3-compartment model with first-order absorption and elimination. The first distribution process revealed administration routedependent characteristics; after i.v. dosing the initial distribution phase was faster than after p.o dosing. Therefore, V2, V3 and Q3 were separately estimated for i.v. or p.o. data. Typical Vsspo and Vssiv were large 95.8 L and 130.3 L, resp. ; , CL was 21.5 L h and Q3 15-fold higher for i.v. than for p.o. data 99.8 L h vs. 6.61 L h ; . Absolute bioavailability was significantly lower for p.o. solution than for p.o. capsule 34% vs. 43% the capsule showed an additional lag time of 0.154 h. Covariate analysis revealed a statistically significant relation between KA and dose. It was best described by a positive saturation function resulting in KAmax of 0.43 h-1 which was nearly reached at the dose of 5 mg, the dose at 0.5 KAmax was 1.00 mg, i.e. the relation was primarily acting in the low dose range. Interindividual variability estimated for KA, CL, F1 and V2iv was moderate 15% to 46% ; , residual variability was 26% proportional random effect model ; . Imprecision of estimates was generally low with relative standard errors RSE ; The estimates for the evaluation data set based on the final PopPK model were very similar to those of the development data set except of the covariate relation which was not supported by the evaluation data set. Simulations n 500 ; of the evaluation data set based on the final PopPK model but without the covariate relation revealed that almost all observed concentrations of the evaluation data set were covered by the 90% prediction interval of the simulated concentrations. Conclusions: A PopPK model has been successfully developed describing the plasma concentration-time course of cilobradine after administration of different formulations. As the covariate relationship found in the development data set was based on a limited number of data in the low dose range and could not be confirmed in the evaluation.
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4: 15 4: Waitt S. Hurcombe M. Gonzalez Arguedas Comparison of Insulin and Non-insulin Treated Horses, Donkeys and Ponies with Hypertriglyceridemia: 72 Cases Calcium-regulating Hormones, Ionized Calcium and Magnesium and Their Association with Survival in Septic Foals Pharmacokinetics of Butorphanol and Evaluation of Physiological and Behavioral Effects after Intravenous and Intramuscular Administration in Neonatal Foals Vasopressin, ACTH and Cortisol Concentrations in Septic Foals: Correlates with Survival and Non-survival The Effect of Omeprazole Paste on Intragastric pH in Clinically Ill Neonatal Foals Glucose-Based Parenteral Nutrition in Critically Ill Foals: A Retrospective Study of 35 Cases 20022005 ; Disposition of Orally Administered Doxycycline in Foals and Concentrations in Body Fluids and Bronchoalveolar Cells.
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This work was supported by NIH grants 1PO1 CA72009-01A1 to T.A.L. ; and KO8 CA71429-01 and the Beth Israel Deaconess Medical Center Junior Investigator Award to P.O and campral.
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3. Metabolic PARLs Eosinophilic granuloma: heavily infiltrated with eosinophils; lots of cyst-like structures: "roots in air"; Lin & Wyman 1979 Hyperparathyroidism: 10% have no lamina dura; ground glass, inc serum Ca, osteoporosis, stones, bones, vague jaw pain, PARLs Hyperthyroidism: rare bone lesions Shaeffer 1957 OOO ; Fibrous Dysplasia - diffuse on Xray; biopsy feels like cutting styrofoam. Slow expansion of bone in all directions, ground glass; Natkin 1994 JOE: Zebra Gauchers: pt has no glucocerebrosides Lipid Metabolism Disease ; , lots of foam cells, roots resorbed slowly; Bender; Pagets: considerable fibrosis, no NSRCT healing; 7: 1 max; ground glass Vitamin D resistant Ricketts - multiple PARLs even on virgin teeth 4: Odontogenic PARLs Botyroid odontogenic cyst mulitlocular lateral periodontal cyst Odontogenic keratocyst: Nohl & Gulabivala 1996 Hancock & Brown 1986.
Can it be done? Rev Respir Dis 1983; 127 suppl ; : S42-S43 15 Idell S, Cohen AB. Alpha1-antitrypsin deficiency. Clin Chest Med 1983; 4: 359-75 Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics 1982; 38: 963-74 Jennrich RI, Schluchter MD. Unbalanced repeated measures models with structured covariance matrices. Biometrics 1986; 42: 805-20. Wu MC, Carroll RJ. Estimation and comparison of changes in the presence of informative right censoring by modeling the censoring process. Biometrics 1988; 44: 175-88 Wu MC, Bailey KR. Estimation and comparison of changes in the presence of informative right censoring: conditional linear and camptosar.
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