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, meaning that patients often need to fast before or after doses to control the uptake from the gastrointestinal tract into the blood stream.
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
Rapid Formulation Development and Clinical Testing of Gastro-Retentive Controlled Release Technology to Enable Once-Daily Dosing
MK-X had demonstrated poor colonic absorption in dogs and conventional matrix based controlled release formulations failed to achieve adequate trough concentrations in a human pharmacokinetic (PK) study to support once daily dosing.