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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Shin, Young G. Jones, Steve A. Murakami, Stan C. Liu, Lichuan Wong, Harvey Buonarati, Michael H. Hop, Cornelis E. C. A. |
| Description | Country affiliation: United States Author Affiliation: Shin YG ( Department of Drug Metabolism and Pharmacokinetics, Genentech, South San Francisco, CA, 94080, USA. yshin@gene.com) |
| Abstract | A liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method was developed and validated for the determination of GDC-0834 and its amide hydrolysis metabolite (M1) in human plasma to support clinical development. The method consisted of semi-automated 96-well protein precipitation extraction for sample preparation and LC-MS/MS analysis in positive ion mode using TurboIonSpray® for analysis. D6-GDC-0834 and D6-M1 metabolite were used as internal standards. A linear regression (weighted 1/concentration(2) ) was used to fit calibration curves over the concentration range of 1 - 500 ng/mL for both GDC-0834 and M1 metabolite. The accuracy (percentage bias) at the lower limit of quantitation (LLOQ) was 5.20 and 0.100% for GDC-0834 and M1 metabolite, respectively. The precision (CV) for samples at the LLOQ was 3.13-8.84 and 5.20-8.93% for GDC-0834 and M1 metabolite, respectively. For quality control samples at 3, 200 and 400 ng/mL, the between-run CV was ≤ 7.38% for GDC-0834 and ≤ 8.20% for M1 metabolite. Between run percentage bias ranged from -2.76 to 6.98% for GDC-0834 and from -6.73 to 2.21% for M1 metabolite. GDC-0834 and M1 metabolite were stable in human plasma for 31 days at -20 and -70°C. This method was successfully applied to support a GDC-0834 human pharmacokinetic-based study. |
| File Format | HTM / HTML |
| ISSN | 02693879 |
| Issue Number | 11 |
| Volume Number | 26 |
| e-ISSN | 10990801 |
| Journal | Biomedical Chromatography |
| Language | English |
| Publisher | Wiley |
| Publisher Date | 2012-11-01 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Discipline Analytical Chemistry Discipline Molecular Biology Discipline Biochemistry Discipline Pharmacology Chromatography, Liquid Methods Pyrimidinones Blood Tandem Mass Spectrometry Thiophenes Chemical Precipitation Double-blind Method Drug Stability Humans Linear Models Chemistry Metabolism Pharmacokinetics Reproducibility Of Results Sensitivity And Specificity Journal Article Randomized Controlled Trial |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine Analytical Chemistry Drug Discovery Clinical Biochemistry Biochemistry Molecular Biology Pharmacology |
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