کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
1222792 | 967871 | 2008 | 12 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal: Part IV. Examples of application
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کلمات کلیدی
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
A harmonized approach for the validation of analytical methods based on accuracy profile was introduced by a SFSTP commission on the validation of analytical procedure. This fourth and last document aims at illustrating this methodology and the statistics used. Therefore the validation of real case methods are proposed such as methods for the quality control of drugs, for the quantitation of impurities in drug substances, for bioanalysis or for the determination of nutriments. Furthermore, different types of analytical methods are used in order to demonstrate the applicability of the proposed approach to a wide range of methods such as liquid chromatography (LC-UV, LC–MS), spectrophotometry or ELISA.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 48, Issue 3, 4 November 2008, Pages 760–771
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 48, Issue 3, 4 November 2008, Pages 760–771
نویسندگان
Ph. Hubert, J.-J. Nguyen-Huu, B. Boulanger, E. Chapuzet, N. Cohen, P.-A. Compagnon, W. Dewé, M. Feinberg, M. Laurentie, N. Mercier, G. Muzard, L. Valat, E. Rozet,