November 3, 2019
American Association of Pharmaceutical Scientists - PharmSci 360
Henry B. Gonzalez Convention Center
November 3-6, 2019
AAPS provides a dynamic forum for the exchange of knowledge among scientists. This annual gathering is a major resource of scientific advances and provides opportunities for networking, on-going education, and professional development for pharmaceutical scientists. This year's AAPS features the 2003 co-winner of the Nobel Prize in Chemistry, Peter Agre, M.D., as one of its plenary speakers.
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SPEAKER
Optimized Microflow LC-MS/MS Methods for the Bioanalysis of Large Molecules
Shane Needham, Ph.D.
Monday, November 4, 2019
10:00 AM - 10:30 AM
Dr. Needham will present optimized approaches for the LC-MS/MS bioanalysis of ADC’s, peptides and proteins. The use of microflow LC-MS, the importance of using ESI sources designed for microflow-LC-MS, and how micro solid-phase extraction and immunocapture can be used for optimal analysis of peptides and proteins by LC-MS will be discussed. Approaches for method development, validation and sample analysis will be described. View on Website
POSTER PRESENTATION
Development and Validation of LC-MS/MS Methods for the Quantitation of Commonly Co-administered Drugs and in Support of Several Clinical Studies
Presented by Ashley Davie
Wednesday, November 6, 2019
11:30 AM, Forum 12, Monitor 77
The 2018 FDA Guidance for the Validation of Bioanalytical Methods requires an assessment of the impact of the presence of co-administered drugs on the analytical measurement and stability of novel drug candidates. GLP-compliant methods were developed and validated in support of a clinical study that featured co-administration of itraconazole, paroxetine, cimetidine, moxifloxacin, and valproic acid with a proprietary drug candidate. Various methods involving protein-precipitation and liquid-liquid extraction were employed utilizing direct-analysis or dilution of supernatant as well as evaporation with nitrogen followed by reconstitution of analyte in organic solvent. Read the Abstract
RECENT PUBLICATION
Bioanalysis Published online: 16 October 2019 ahead of print
Validating stability and selectivity in the presence of co-administered compounds
Sharon DeChenne, Katherine Yahvah and Jennifer Zimmer
Contract research organizations (CROs), pharmaceutical companies and regulators have extensively discussed co-administered stability since it was brought up in 2010 at the Fourth Calibration and Validation Group Workshop on Recent Issues in Regulated Bioanalysis. The questions are whether or not co-administered drugs impact the stability of an analyte, and what regulatory requirements should exist for cases of co-administered drugs. Read More
UPCOMING EVENTS
AAPS PharmSci 360
Nov 3 - 6, 2019
Speaker: Shane Needham, Ph.D.
Poster Presentation: Ashley Davie
Henry B. Gonzalez Convention Center
San Antonio, TX
PacMass Members' Night Socialand Poster Session
Nov 13, 2019
Poster Presentation: Sharon DeChenne
Fred Hutchinson Cancer Research Center
Seattle, WA
European Bioanalysis Forum
Nov 20-22, 2019
Poster Presentation: Chad Christianson
Hesperia Hotel
Barcelona, Spain
Society of Toxicology 59th Annual Meeting & Expo
March 15-19, 2020
Anaheim Convention Center
Anaheim, CA
