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Virtual population pharmacokinetic using physiologically based pharmacokinetic model for evaluating bioequivalence of oral lacidipine formulations in dogs

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Asian Journal of Pharmaceutical Sciences 2017年第1期12卷 98-104页

作者： Bin Yang Chunnuan Wu Bin Ji Mingrui Wu Zhonggui He Lei Shang Jin Sun Department of Pharmaceutics School of PharmacyShenyang Pharmaceutical UniversityShenyangChina Department of Pharmacy Tianjin Medical University Cancer Institute and HospitalTianjinChina Department of Pharmaceutical analysis School of PharmacyShenyang Pharmaceutical UniversityShenyangChina School of Pharmacy China Medical UniversityShenyangChina Municipal Key Laboratory of Biopharmaceutics School of PharmacyShenyang Pharmaceutical UniversityShenyangChina

The aim of the present study was to investigate virtual population pharmacokinetic using physiologically based pharmacokinetic(PBPK) model for evaluating bioequivalence of oral lacidipine formulations in dogs. The dissolution behaviors of three lacidipine formulations including one commercial product and two self-made amorphous solid dispersions(ASDs)capsules were determined in 0.07% Tween 80 media. A randomized 3-period crossover design in 6 healthy beagle dogs after oral administration of the three formulations at a single dose of 4 mg was conducted. The PBPK modeling was utilized for the virtual bioequivalence *** vitro dissolution experiment showed that the dissolution behaviors of lacidipine amorphous solid dispersions(ASDs) capsules, which was respectively prepared by HPMC-E5 or Soluplus, as polymer displayed similar curves compared with the reference formulation in 0.07% Tween 80 media. In vivo pharmacokinetics experiments showed that three formulations had comparable maximum plasma drug concentration(Cmax), and the time(Tmax) to reach Cmax of lacidipine tablet, which was prepared by Soluplus, as polymer was slower than other two formulations in consistency with the in vitro dissolution rate. The 90% confidence interval(CI) for the Cmax, AUC0–24 h and AUC0–∞ of the ratio of the test drug to the reference drug exceeded the acceptable bioequivalence(BE) limits(0.80–1.25). However, the 90% CI of the AUC0–24 h, AUC0–∞ and Cmax of the ratio of test to reference drug were within the BE limit,calculated using PBPK modeling when the virtual subjects reached 24 dogs. The results all demonstrated that virtual bioequivalence study can overcome the inequivalence caused by inter-subject variability of the 6 beagle dogs involved in in vivo experiments.

关键词： physiologically based pharmacokinetic model Virtual population pharmacokinetic Bioequivalence Lacidipine Amorphous solid dispersions

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The Chapman-Richards Distribution and its Relationship to the Generalized Beta

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Forest Ecosystems 2019年第3期6卷 219-235页

作者： Jeffrey H.Gove Thomas B.Lynch Mark J.Ducey USDA Forest Service Northern Research Station271 Mast Road Durham 03824NHUSA Professor Emeritus Department of Natural Resource Ecology and ManagementOklahoma State UniversityAg Hall Room 008CStillwater 74078OKUSA Department of Natural Resources and the Environment University of New Hampshire114 James Hall Durham 03824NHUSA

Background: The Chapman-Richards distribution is developed as a special case of the equilibrium solution to the McKendrick-Von Foerster equation. The Chapman-Richards distribution incorporates the vital rate assumptions of the Chapman-Richards growth function, constant mortality and recruitment into the mathematical form of the distribution. Therefore, unlike 'assumed' distribution models, it is intrinsically linked with the underlying vital rates for the forest area under consideration. Methods: It is shown that the Chapman-Richards distribution can be recast as a subset of the generalized beta distribution of the first kind, a rich family of assumed probability distribution models with known properties. These known properties for the generalized beta are then immediately available for the Chapman-Richards distribution, such as the form of the compatible basal area-size distribution. A simple two-stage procedure is proposed for the estimation of the model parameters and simulation experiments are conducted to validate the procedure for four different possible distribution shapes. Results: The simulations explore the efficacy of the two-stage estimation procedure;these cover the estimation of the growth equation and mortality-recruitment derives from the equilibrium assumption. The parameter estimates are shown to depend on both the sample size and the amount of noise imparted to the synthetic measurements. The results vary somewhat by distribution shape, with the smaller, noisier samples providing less reliable estimates of the vital rates and final distribution forms. Conclusions: The Chapman-Richards distribution in its original form, or recast as a generalized beta form, presents a potentially useful model integrating vital rates and stand diameters into a flexible family of resultant distributions shapes. The data requirements are modest, and parameter estimation is straightforward provided the minimal recommended sample sizes are obtained.

关键词： Diameter distributions Chapman-Richards growth Generalized beta distribution of the first kind Maximum likelihood McKendrick-Von Foerster equation physiologically structured population model Size-structured distributions

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