کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10162282 | 1114324 | 2014 | 9 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Application and Validation of an Advanced Gastrointestinal In Vitro Model for the Evaluation of Drug Product Performance in Pharmaceutical Development
دانلود مقاله + سفارش ترجمه
دانلود مقاله ISI انگلیسی
رایگان برای ایرانیان
کلمات کلیدی
Dissolution - انحلال Solubility - انحلال پذیریIntestinal absorption - جذب رودهBioavailability - فراهم زیستیFormulation - فرمولاسیونPhysiological model - مدل فیزیولوژیکیPoorly soluble drugs - مواد مخدر به میزان قابل ملاحظه ای حل می شودin vitro/in vivo correlations (IVIVC) - همبستگی in vitro / in vivo (IVIVC)
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: Application and Validation of an Advanced Gastrointestinal In Vitro Model for the Evaluation of Drug Product Performance in Pharmaceutical Development Application and Validation of an Advanced Gastrointestinal In Vitro Model for the Evaluation of Drug Product Performance in Pharmaceutical Development](/preview/png/10162282.png)
چکیده انگلیسی
Methods to understand and predict the oral bioavailability of drug products are a prioritized research area within the pharmaceutical industry. Models to predict oral bioavailability have the potential to reduce risk, time, and cost in development as well as decrease the need for animal studies. The TNO intestinal model (TIMâ1) is an advanced dissolution model deployed by AstraZeneca since 2008. This article presents a systematic evaluation of TIMâ1 against in vivo data. The relative performance of compounds and formulations tested in TIMâ1 and in vivo was compared both by a qualitative analysis and a linear regression analysis of relative exposure measures between test and reference formulations in TIMâ1 and in vivo. The TIMâ1 correctly predicted in vivo rank order in 84% and 79% of cases for AUC and Cmax, respectively, when using the 3âh time point. There was only one case for Cmax in which TIMâ1 did not predict an in vivo difference. The correlation coefficient (R2) between relative (test vs. reference formulations) fraction available in TIMâ1 after 3 h and AUC was 0.78. Thus, this study suggests that the TIMâ1 system can be used to assess the risk for significant differences in exposure between formulations and compound modifications. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association J Pharm Sci 103:3704-3712, 2014
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 11, November 2014, Pages 3704-3712
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 11, November 2014, Pages 3704-3712
نویسندگان
Richard Barker, Bertil Abrahamsson, Martin Kruusmägi,