Despite the significant progress in the polymorph prediction field, the polymorph screening still remains one of the crucial steps in the drug product development...
In this series, we will discuss how it is possible to accelerate from Candidate Selection to Phase I FIH cost effectively, within 12 months, and with visibility into future clinical trials. A recent survey of 150 biopharmaceutical development scientists concludes:
Formulation issues have led to project failure and significant delays for about 60% of responding companies.
Of those projects, a delay of more than 12 months was reported by 52%
10% experienced complete failure
This study's findings highlight the importamce of first-time-right development to avoid costly delays.