کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
2485416 | 1114354 | 2012 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Interdependence of Drug Substance Physical Properties and Corresponding Quality Control Strategy
دانلود مقاله + سفارش ترجمه
دانلود مقاله ISI انگلیسی
رایگان برای ایرانیان
کلمات کلیدی
Dissolution - انحلال Particle size - اندازه ذراتPrinciple component analysis - تجزیه و تحلیل اجزای اصلMultivariate analysis - تحلیل چندمتغیرهPhysical characterization - خصوصیات فیزیکیPhysical property - دارایی فیزیکیSolid dosage form - فرم دوز جامدDesign space - فضای طراحیDrug substance - مواد مخدرQuality by design - کیفیت طراحی
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
پیش نمایش صفحه اول مقاله
![عکس صفحه اول مقاله: Interdependence of Drug Substance Physical Properties and Corresponding Quality Control Strategy Interdependence of Drug Substance Physical Properties and Corresponding Quality Control Strategy](/preview/png/2485416.png)
چکیده انگلیسی
In quality by design (QbD) paradigm, specifications on active pharmaceutical ingredients (APIs) are a critical component of the overall control strategy to ensure drug product quality. In establishing appropriate specifications for highly correlated API properties, multivariate specifications were advocated recently (Duchesne C, MacGregor JF. 2004. J Qual Technol 36:78-94). In this text, we reviewed several scenarios where API properties are of varying degrees of intercorrelation, and discussed the corresponding control strategies. One scenario was further analyzed, in which high degree of property intercorrelation could afford a single univariate specification and, thereby, simplify the control strategy. In the case study provided, we first mapped the potential design space of the API physical properties, and subsequently compared the effectiveness of univariate and multivariate control strategies. On the basis of the comparison, a single univariate control scheme was proposed and boundary was defined. Finally, width of the design space for API physical properties was assessed, and the effectiveness of the API manufacturing process control was preliminarily evaluated. © 2011 Wiley Periodicals, Inc. and the American Pharmacists Association.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 101, Issue 1, January 2012, Pages 312-321
Journal: Journal of Pharmaceutical Sciences - Volume 101, Issue 1, January 2012, Pages 312-321
نویسندگان
Yong Cui, Xiling Song, Mark Reynolds, King Chuang, Minli Xie,