MEI Pharma has leveraged Quotient's Translational Pharmaceutics® platform to expedite development of its next-generation cancer therapy ME-401.
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.
AAPS 2017 on-stand presentations
Quotient scientists answer your questions surrounding spray drying, formulation optimization, GMP manufacturing and pediatric formulation.
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.
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.
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.
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
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.
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.
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.
Formulation Development - Spray Drying
We use a broad range of formulation approaches to address complex solubility and bioavailability challenges, ensuring technology selection is driven by molecule need.