کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10553613 | 967878 | 2009 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Tartrate-resistant acid phosphatase (TRACP 5b): A biomarker of bone resorption rate in support of drug development: Modification, validation and application of the BoneTRAP® kit assay
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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
Method validation experiments were conducted for: inter- and intra-assay accuracy and precision, establishment of SC, range finding of different population groups, selectivity tests, parallelism and stability. The analytical range was 1.00-10.0 U/L and the total errors of lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ) validation samples were 8% and 21%, respectively. Data of range finding experiment showed that serum samples should be collected in tubes instead of bags. Selectivity results showed accurate spike recovery among the majority of test samples from target populations. Samples were demonstrated to be stable for up to four freeze/thaw cycles and for 24 months at â70 ± 10 °C. Our results show that the modified TRACP 5b method is reliable for the quantification of TRACP 5b in human serum samples to support clinical trials of bone resorptive effect reflected by TRACP 5b activities. The method was robust with similar assay performance characteristics shown in three bioanalytical laboratories.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 49, Issue 5, 12 July 2009, Pages 1203-1212
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 49, Issue 5, 12 July 2009, Pages 1203-1212
نویسندگان
Yuling Wu, Jean W. Lee, Lennie Uy, Bassam Abosaleem, Han Gunn, Mark Ma, Binodh DeSilva,