Shortening The Timeline To First In Human (FIH) Clinical Dosage Form For Oral/Injectable Delivery

Lengthy early development timelines are common across new & emerging biotech companies for a multitude of reasons. Striking the right balance of speed, quality, risk, and investment allows you to shorten timelines and work with efficiency. Strategies adopted for a rapid development of a simple yet flexible format proves beneficial. 

In recent years, with more clinical candidates being explored for niche indications, orphan drugs, and for indications with a rapid clinical end point, the pathway to the later clinical phase is short and there is not enough time to perform bridging studies. Hence a more scalable dosage form may need to be developed. Join our discussion highlighting the strategies that will bring success in early development for oral solid dosage form and for injectable formats.