Fact Sheet: Proof Of Concept Study

Aptuit INDiGOTM is a service which provides fast access to human data even for poorly bioavailable drugs.

The deliverables include Phase I clinical trial supplies and IND documentation in 26 weeks when API is supplied. API production can also be included in a 52 week option.

Services cover preclinical, solids, formulation, analytical, clinical packaging, quality assurance, and regulatory.

Various formulation approaches are available. One unique approach is the use of an amorphous dispersion in a capsule (ADIC) formulation. This dosage form provides improved bioavailability for poorly soluble compounds without formulation development and provides an easy administration route for first-in-human clinical trials.