Quotient Clinical Demonstrates Drug Product Optimization with Integrated Platform

Quotient Clinical has announced the availability of a white paper demonstrating the advanced capabilities of the RapidFact approach: an integrated formulation development, manufacture and clinical testing service.

The service can be used to optimize drug products with shorter timelines and reduced associated expenditure compared to traditional approaches. The white paper, entitled "RapidFact - a New Paradigm for the Effective Optimization of Oral Dosage Forms", is available for download free-of-charge.

A conventional drug product optimization process involves iterative rounds of screening multiple formulation prototypes in preclinical species to identify a limited number of "lead" systems to progress into human clinical PK studies. This process is time consuming and expensive, costing over £1 million (US$1.6 million) and taking over 18 months. The service can reduce this timeline by up to two thirds and reduce associated costs.

RapidFact exploits the Translational Pharmaceutics platform which integrates formulation development, Good Manufacturing Practice (GMP) drug product manufacture and clinical testing facilities to allow products to be manufactured and investigated in a clinical study in timeframes as short as 24 hours.

Candidate formulations can be rapidly screened, selected and validated on the basis of human clinical data. This significantly improves the precision by which an optimal drug product that matches the desired target product profile can be identified.