Quotient Clinical Showcases ‘Gold Standard’ Human ADME Studies and Applications
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Quotient Clinical will present a symposium and three poster publications at the forthcoming 19th North American ISSX Meeting / 29th JSSX Meeting (ISSX/JSSX 2014) from October 19th to 23rd in San Francisco, USA.
The symposium entitled “Defining a 'Gold standard’ for establishing intravenous pharmacokinetics, human mass balance and metabolism data from a single integrated study and a single regulatory submission” will focus on the delivery and conduct of human 14C-enabled metabolism and pharmacokinetic studies intended to support drug registration.
The poster publications describe recent advancements in the design of integrated clinical programs to generate pivotal pharmacokinetic and metabolism data addressing key development and regulatory requirements.
Details of the symposium and poster presentations are:
Defining a 'Gold standard’ for establishing intravenous pharmacokinetics, human mass balance and metabolism data from a single integrated study and a single regulatory submission
Thursday, October 23rd, 7:30 - 8:30am in the Imperial Ballroom
Flexible strategies for the conduct of human metabolism studies with oncology molecules
Session 4, Tuesday, October 21st, 5.30 - 7:00pm
Abstract Id: 33582, Poster No P344
An integrated strategy to determine the absorption, distribution, metabolism, and excretion, and the absolute bioavailability of Bevenopran (CB-5945) in healthy male subjects
Session 4, Tuesday, October 21st, 5.30 - 7:00pm
Abstract Id: 33615, Poster No P326
Intravenous studies in man: Teasing apart absorption and clearance drivers of pharmacokinetic variability and dose and time dependent non-linearity
Session 4, Tuesday, October 21st, 5.30 - 7:00pm
Abstract Id: 33880, Poster No P382
