A rapid formulation development and clinical testing program to evaluate the pharmacokinetics of a novel enabled formulation of abiraterone acetate - AAPS 2016
Following initial dosing, the Translational Pharmaceutics platform also allows GMP drug products to be made in real-time in response to interim analysis of clinical data, typically on a 7-14 day cycle.
Maximising the potential of amorphous spray-dried dispersions - AAPS 2016
Maximising the Potential of Amorphous Spray-Dried Dispersions to Enhance Clinical Bioavailability. Amorphous Dispersions (ADs) provide an effective approach to oral bioavailability improvement for poorly soluble compounds
Site of absorption of an oral formulation of semaglutide - ADA 2017
Absorption of oral peptide-based drug formulations is challenged by the fact that peptides are degraded in the stomach due to low pH and proteolytic enzymes, as well as by their limited permeability across the gastrointestinal epithelium.
A pharmacoscintigraphic study of the relationship between tablet erosion and pharmacokinetics of oral semaglutide - ADA 2017
When administered orally, peptide-based drugs are susceptible to degradation in the stomach due to exposure to low pH and proteolytic enzymes.
A randomised double-blind dose escalation study- ASCPT 2016
A randomised double-blind dose escalation study to evaluate the safety and dose response of subcutaneous administration of coversin in healthy subjects.
Clinical Pharmacokinetics and Pharmacodynamics of ME-401 - AACR 2016
Clinical Pharmacokinetics and Pharmacodynamics of ME-401, an Oral, Potent and Selective Inhibitor of Phosphatidylinositol 3-Kinase P110δ, Following Single Ascending Dose Administration to Healthy Volunteers
Breathing new life into Phase 1 trials. Quotient's approach is helping Pulmatrix to develop a range of inhaled dry powder chemical entities based on its iSPERSE™ technology to meet unmet medical needs in multiple respiratory diseases.
An accelerated approach to clinical trials. Corcept Therapeutics is developing CORT125134, a promising candidate for the treatment of Cushing’s syndrome, a rare disorder associated with significant morbidity and mortality.
Clovis Oncology has chosen Quotient’s drug product optimization approach for rociletinib, a promising oral candidate drug for the treatment of EGFR-resistant non-small cell lung cancer.
Protein kinase inhibitors (PKIs) are used in the treatment of cancer and inflammation, but food interactions are a common problem with this class of drugs. Swedish drug delivery company Xspray has used its Hybrid Nanoparticle (HyNap™) technology to improve the bioavailability of the PKI nilotinib, reducing the required dose and significantly lowering the food interaction of the drug compared with the marketed product.
Human ADME studies
With over 30 years’ experience as a world leading provider of human ADME 14C radiolabeled studies, we have the scientific expertise and operational know-how to design and deliver human ADME programs in preparation for NDA, MAA and global regulatory filings.
Accelerating development of enabled formulations for poorly soluble drugs
Efficacy issues due to inadequate gastrointestinal (GI) absorption caused by insufficient aqueous solubility are encountered in up to 70% of new drugs in development.1 Typically, in vitro analysis and preclinical studies are used to predict the behaviour of the drug in vivo