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Scientific Posters
Application Of Non Standard Approaches To Investigations Of Human Mass Balance And Metabolite Characterisation
Conventional human metabolism studies are well understood study designs which help drug companies generate data to support drug development and registration. Variations from conventional study designs can be required as a result of the specific characteristics of individual drugs or the need for particular data to support drug registration. This poster describes scenarios where alternative study designs and approaches have been required.
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Scientific Posters
An Evaluation of the Pharmacodynamics, Safety, and Tolerability of the Potassium Binder RDX7675
The aim of the phase 1, single-center, randomized, active-controlled study in healthy volunteers reported in this paper was to investigate the pharmacodynamic effects and safety of different dosing regimens of RDX7675 in humans.
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Scientific Posters
Enhanced formulation decision-making in early phase clinical trials for parenteral products
This presentation describes the principles and applications of Translational Pharmaceutics: an R&D platform integrating formulation development, real-time adaptive GMP manufacturing and clinical testing in order to accelerate drug development cycles.
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Scientific Posters
Real-time drug product manufacturing to enable accelerated early clinical development of spray dried dispersion based formulations - AAPS 2017
This poster describes how adopting a real-time drug product manufacturing approach allowed initiation of the FIH study within 12 weeks of initiating SDD process transfer.
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Scientific Posters
AAPS 2017 on-stand presentations
Quotient scientists answer your questions surrounding spray drying, formulation optimization, GMP manufacturing and pediatric formulation.
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Scientific Posters
Enabling Clinical Assessment of Maralixibat for Rare Pediatric Liver Disease via Real Time Adaptive GMP Manufacturing - AAPS 2017
A flexible, real-time adaptive GMP manufacturing model is required to support the increasing requirement for clinical trial conduct in small patient populations with challenging trial designs and treatment algorithms.
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Scientific Posters
A feasibility study to assess the acceptability of solid dosage forms in children - EuPFI 2017
Pediatric formulation development is currently a hot topic within the pharmaceutical industry, this poster describes a feasibility study to assess the acceptability of solid dosage forms in children.
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Scientific Posters
Cocktail approach for assessing CYP450 drug-drug interaction liabilities - ISSX 2017
This poster explains the cocktail approach for assessing CYP450 drug-drug interaction liabilities including assessment of differential inhibition of liver and gut CYP3A4.
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Scientific Posters
Using 14C radiolabeled clinical studies to explore and evaluate factors influencing oral exposure - ISSX 2017
This poster describes a 2 part study combing an IV microtracer study with a conventional oral ADME study
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Scientific Posters
Comparisons between US and UK regulatory environments for conducting Phase I clinical research - AAPS 2016
The objective of this poster is to provide comparative information on the CTA and IND applications, highlighting factors that may influence companies in deciding where to conduct Phase I clinical research.
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Scientific Posters
14C Microtracer approaches to inform formulation development strategies in early clinical drug development - AAPS 2016
This poster describes how combining an intravenous (IV) microtracer regimen with an oral tracer regimen, can generate key pharmacokinetic (PK) parameters.
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Scientific Posters
Formulation selection and development for ME-401 during a first-in-human study in healthy volunteers - AAPS 2016
Formulation selection and development for ME-401, an oral, potent and selective inhibitor of phosphatidylinositol 3-kinase P110δ during a first-in-human study in healthy volunteers.