12 / 97 resources displayed
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Scientific Posters
Working with Short Shelf-Life Products in Clinical Development
Working with Short Shelf-Life Products in Clinical Development – Driving Efficiencies and Overcoming Challenges
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Scientific Posters
Delivery of Antibodies to the Gastrointestinal Tract for Local Action
There has been increasing interest in the oral administration of antibodies for localised treatment of infections or other conditions in the gastrointestinal (GI) tract.
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Scientific Posters
Intravenous and Oral Microdose Pharmacokinetics
Intravenous and Oral Microdose Pharmacokinetics of Three Novel Inhibitors of FabI in Healthy Subjects
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Scientific Posters
Biosimilars: A Transatlantic Drift?
With the first generation of biotherapeutics agents now nearing or having reached patent expiry, the potential for follow-on biotherapeutics is now presenting industry and regulatory bodies with novel challenges.
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Scientific Posters
Intravenous studies in man
Intravenous studies in man: Teasing apart absorption and clearance drivers of pharmacokinetic variability and dose and time dependent non-linearity
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Scientific Posters
Adaptive manufacturing: a new paradigm to improve efficiency and effectiveness in early oncology development - AAPS 2014
There is an unmet need in the industry for a more efficient and flexible approach to provide drug product for early clinical studies. Presented here is an innovate approach to overcome these challenges by utilising a real-time, adaptive manufacturing and supply platform.
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Scientific Posters
Flexible strategies for the conduct of human metabolism studies with oncology molecules - ISSX 2014
The key objectives of human ADME studies are to evaluate mass balance, determine the routes and rates of elimination and gain an understanding of the metabolic fate of the drug.
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Scientific Posters
Conduct of clinical ADME study for Vosaroxin in oncology patients - AAPS 2015
Conduct of clinical ADME study for Vosaroxin in oncology patients via real-time adaptive manufacture of intravenous drug product.
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Scientific Posters
Application of Translational Pharmaceutics® to reduce time, cost and risk in the early development of inhaled drug products - RDD 2015
The efficiency and effectiveness of new drug development has remained problematic over the last decade. Translational Pharmaceutics has emerged as a new paradigm to improve R&D productivity.
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Scientific Posters
Real time adaptive manufacturing - a new paradigm for personalized drug products in clinical development - AAPS 2015
This poster reports on a new real-time adaptive GMP manufacturing paradigm serving patient and study needs by delivering personalized drug products on demand.
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Scientific Posters
Absorption, metabolism and excretion of [14C]-gemigliptin - ISSX 2016
Absorption, metabolism and excretion of [14C]-gemigliptin, a novel dipeptidyl peptidase 4 inhibitor, in humans.
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Scientific Posters
A Phase I, open-label, 2-Part study to establish absolute bioavailability - DMDG 2016
A Phase I, open-label, 2-Part study to establish absolute bioavailability and the ADME of evogliptin in healthy male subjects by light-label approach.