BDD Swift - adaptive clinical studies

•SWIFT accelerates evaluation and optimisation of product performance using in vivo clinical data to direct formulation design in real time.
•SWIFT studies enable you to make decisions on formulation changes based on emerging clinical data. • This integration of formulation development, GMP manufacturing and clinical testing activities can reduce time from initial prototype development to clinical evaluation in as little as 6 months. 

Traditional pharmaceutical development pathways perform product development and clinical testing sequentially, despite the fact that the in vitro tools available to formulators provide no guarantee of success in complex in vivo conditions. The result is a process that is almost trial and error, with performance not fully understood until the last stages of lengthy and expensive development and scale up cycles. If the desired outcomes are not achieved, the process will either need to be repeated with an optimised product or the programme cancelled.

BDD SWIFT provides an alternative to this classical model by enabling product performance to be optimised using continuous feedback from real clinical results to direct formulation design in real time. This integration of formulation development, GMP manufacturing and clinical testing activities can reduce time from initial prototype development to clinical evaluation to just 6 months while dramatically improving chances of a successful outcome.

There are 3 key stages in a successful SWIFT clinical study:

1. Formulation Design –incorporate carefully considered variables within a pre-determined design space to allow optimisation of formulation performance in vivo

2. Clinical Trial Design – an adaptable clinical trial design enabling rapid optimisation of your product with the minimal number of study arms

3. Rapid evaluation of pharmacokinetics – quick and accurate results from each study arm allows time to evaluate data and initiate nimble formulation changes before the next dosing