RapidFIH

Quotient has a unique Translational Pharmaceutics™ platform that utilises our integrated formulation development, GMP drug product manufacture, and clinical testing capabilities.  We support our clients to select the optimal formulation for a First-in-Human (FIH) study which we can then develop, manufacture, and make available for dosing. This typically enables a rapid timeline to achieve the key milestone of First Subject First Dose (FSFD).

Drug products are typically manufactured in “real time” at volumes required to support the on-going clinical study, reducing API consumption and associated expenditure. Our integrated platform also allows tailored dose increments to be manufactured during an ascending dose protocol, increasing the precision of the data.  We are also able to switch the nature of the drug product (e.g. solution to solid) mid-way through a protocol in response to emerging data.

For more information on the application of this process download this fact sheet and take a look at our RapidFACT pages.