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December 17, 2012
Application of GC/MS/MS in Monitoring Steriods as a Pharmacokinetic and Pharmacological Biomarker |
SPEAKER FOR THIS EVENT: 
Clark Williard, Executive Director, Mass Spectrometry Operations, PharmaNet/i3  |
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Estrogens (estradiol and estrone) and androgens (testosterone and androstenedione) are a class of biologically important endogenous compounds. Endogenous and exogenous estrogens are associated with the pathogenesis of breast cancer whereas testosterone affects major biological functions and is used as a therapeutic agent for the treatment of hypogonadism, the stimulation of erythropoiesis and hereditary angioneurotic edema. As a consequence, measurement of estrogens and androgens, both bound and free, is of high biological importance. Assay specificity, sensitivity, precision, and accuracy are particularly problematic at lower concentrations that are typically observed in women and men with androgen deficiency and post-menopausal women. Commonly employed techniques such as RIA (radio immuno assay) and LC-MS/MS often do not meet the limits of quantitation or high specificity required to routinely quantify physiologically relevant levels in such samples.
Negative ion chemical ionization (NCI) GC-MS/MS, however, can deliver the quantitative limits required for these challenging samples. A GC-MS/MS bioanalytical assay will be show-cased to demonstrate the high sensitivity, specificity, precision, and accuracy offered by GC-MS/MS that is implemented to help elucidate the pharmacokinetic parameters of hormone replacement therapy and the monitoring of endogenous estrogens and androgens as a pharmacodynamic biomarker. |
This webinar is Part of a series about innovative approaches and specialized techniques to bioanalytical studies
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Bioanalytical scientists; laboratory, outsourcing, and project managers and directors.
This webinar series invites you to find out more about our innovative approaches and specialized techniques to bioanalytical studies to help you meet your project objectives.
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Clark Williard, Executive Director, Mass Spectrometry Operations, PharmaNet/i3
Mr. Williard has more than 18 years of experience in the mass spectrometry bioanalysis field of research supporting the pharmaceutical industry. In 1994, Mr. Williard joined Taylor Technology, Inc., a small lab of seven employees, focusing efforts in methods development and validation utilizing LC-MS/MS and GC-MS/MS techniques. Mr. Williard’s other interests included the development and deployment of Taylor Technology’s laboratory automation program. At PharmaNet, Mr. Williard held such laboratory positions as Senior Scientist and Research Scientist. He has functioned as bioanalytical Principal Investigator in regulated studies for 12 years. As Executive Director, Mr. Williard has overseen daily operations of PharmaNet/i3’s mass spectrometry laboratory for seven years including responsibilities in financial performance and resource allocation. He functions as GLP Manager of the laboratory. Mr. Williard holds a bachelor’s degree from Penn State University. He has authored various articles in peer-reviewed journals and book chapter contributions on bioanalysis supporting the oncology, medical device, and instrumental fields of research. |
| OUR XTALKS PARTNER FOR THIS EVENT: |
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PharmaNet/i3, the inVentiv Health clinical segment, is recognized as a leading provider of global product development services to pharmaceutical, biotechnology, generic drug, and medical device companies, offering therapeutically specialized capabilities for Phase I-IV product development, bioanalytical services, and staffing from a single clinical professional to an entire functional team. For intelligent solutions needed to accelerate high quality product development programs of all sizes around the world, PharmaNet/i3 works for you. |
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