A sponsor contracted Recipharm and Clinical Trial Consultants (CTC) to perform a pharmacokinetic (PK) clinical trial of a new compound.
A sponsor contracted Recipharm and Clinical Trial Consultants (CTC) to perform a pharmacokinetic (PK) clinical trial of a new compound.
5 PagesCASE STUDY: ENHANCING AN API’s PATHWAY TO CLINIC INTRODUCTION A sponsor contracted Recipharm and Clinical Trial Consultants (CTC) to perform a pharmacokinetic (PK) clinical trial of a new compound. In order to get an improved therapy, a modified release dosage form was selected as the desired mode of administration. Services delivered GMP manufacture of active pharmaceutical ingredient (API) D rug p roduct dev elopment an d GMP manufacture (modified release capsules) Clinical study development and implementation with healthy volunteers Bioanalysis Project highlights Overcame multiple development challenges Results delivered in 12 months from project initiation Seamless service: rapid delivery of IMP from Recipharm to CTC 540 study samples analysed in 11 study sample run
