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首页> 外文期刊>Journal of pharmaceutical sciences. >Level A in vitro-in vivo correlation (IVIVC) model with Bayesian approach to formulation series.
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Level A in vitro-in vivo correlation (IVIVC) model with Bayesian approach to formulation series.

机译：采用贝叶斯方法制定制剂系列的A级体外-体内相关性（IVIVC）模型。

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In vitro-in vivo correlation (IVIVC) models for formulation series are useful in drug development, but the current models are limited by their inability to include data variability in the predictions. Our goal was to develop a level A IVIVC model that provides predictions with probabilities. The Bayesian approach was used to describe uncertainty related to the model and the data. Three bioavailability studies of levosimendan were used to develop IVIVC model. Dissolution was tested at pH 5.8 with basket. The IVIVC model with Bayesian approach consisted of prior and observed data. All observed data were fitted to the one-compartment model together with prior data. Probability distributions of pharmacokinetic parameters and concentration time profiles were obtained. To test the external predictability of IVIVC model, only dissolution data of formulations E and F were used. The external predictability was good. The possibility to utilize all observed data when constructing IVIVC model, can be considered asa major strength of Bayesian approach. For levosimendan capsule data traditional IVIVC model was not predictable. The usefulness of IVIVC model with Bayesian approach was shown with our data, but the same approach can be used more widely for formulation optimization and for dissolution based biowaivers. (c) 2006 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 95: 1595-1605, 2006.
机译：用于制剂系列的体外-体内相关性（IVIVC）模型可用于药物开发，但是当前模型受其无法在预测中包括数据可变性的限制。我们的目标是开发一个A级IVIVC模型，该模型提供具有概率的预测。贝叶斯方法用于描述与模型和数据有关的不确定性。左西孟旦的三个生物利用度研究用于建立IVIVC模型。用篮在pH 5.8下测试溶解度。采用贝叶斯方法的IVIVC模型由先验数据和观察数据组成。所有观察到的数据与先前数据一起拟合到一室模型中。获得了药代动力学参数和浓度时间分布的概率分布。为了测试IVIVC模型的外部可预测性，仅使用制剂E和F的溶出数据。外部可预测性很好。建立IVIVC模型时利用所有观测数据的可能性可被认为是贝叶斯方法的主要优势。对于左西孟旦胶囊数据，传统的IVIVC模型是不可预测的。我们的数据显示了采用贝叶斯方法的IVIVC模型的有用性，但是相同的方法可以更广泛地用于配方优化和基于溶出度的生物豁免。 （c）2006 Wiley-Liss，Inc.和美国药剂师协会J Pharm Sci 95：1595-1605，2006。

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