کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10162558 | 1114334 | 2014 | 12 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
High Throughput Prediction of the Long-Term Stability of Pharmaceutical Macromolecules from Short-Term Multi-Instrument Spectroscopic Data
ترجمه فارسی عنوان
پیش بینی عملکرد بالا از ثبات درازمدت ماکرومولکول های دارویی از داده های اسپکتروسکوپی چند منظوره کوتاه مدت
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کلمات کلیدی
فرمول بندی، ثبات، پروتئین، توان بالا، مدل سازی، دایرهروی دایره ای فلورسانس، پراکندگی نور،
موضوعات مرتبط
علوم پزشکی و سلامت
داروسازی، سم شناسی و علوم دارویی
اکتشاف دارویی
چکیده انگلیسی
Changes in the measurements of a macromolecular biopharmaceutical's physical form are often used to predict changes in the drug's long-term stability. These can in turn be used as important markers of changes to a drug's efficacy and safety. Such stability estimates traditionally require human judgment and are frequently tentative. We introduce methods for developing mathematical models that predict a drug's long-term storage stability profile from measurements of short-term physical form and behavior. We measured the long-term (2 year) chemical and colloidal stability of Granulocyte Colony Stimulating Factor (GCSF) in 16 different liquid formulations. Shortly after formulations were placed on stability, we also employed various spectroscopic techniques to characterize the short-term thermal unfolding response of GCSF in the 16 formulations. The short-term data were processed using several data reduction methods, including reduction to spectra at low temperature, to melt curves, and to transition temperatures. Least squares fitting was used to predict the long-term stability measurements from the reduced short-term spectroscopic measurements. On the basis of the cross-validation and a permutation test, many of the long-term stability predictions have less than 1% probability of occurring by chance.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 3, March 2014, Pages 828-839
Journal: Journal of Pharmaceutical Sciences - Volume 103, Issue 3, March 2014, Pages 828-839
نویسندگان
Nathaniel R. Maddux, Vidyashankara Iyer, Weiqiang Cheng, Ahmed M.K. Youssef, Sangeeta B. Joshi, David B. Volkin, John P. Ralston, Gerhard Winter, C. Russell Middaugh,