Intec offers potential partners a rapid and cost effective human proof-of-concept (POC), to demonstrate the superiority of their specific drugs when administered with a designated Accordion Pill™, in comparison to the current, marketed version of these drugs.
Scale-up & Production
|Activity||Development of designated Accordion Pill with partner’s drug, with a desired release profile||Scale up & production for human POC, in Intec’s cGMP pilot production sites||POC study stability and QC/QA batch release||PK human study: AP drug vs. the existing, marketed drug, in healthy volunteers|
|Outcome||dissolution profile||Bio batch for human POC||COA, Stability report||PK profiles|
|Typical Duration, Month||3-4||2||1||3, including Bioanalysis||9-10|