Stability/Clinical Studies - 505(b)(2) - Rate-Limiting

Just moments ago, a pharma company called and asked "Are stability and/or clinical studies the rate limiting factor(s) pertaining to FDA clinical submissions using the 505(b)(2) process"?

My advice to the pharma company was as follows and I would like to share this information in this timely post.

All too often, stability studies are the rate-limiting step in the timelines and flow pertaining to ongoing activities of a clinical submission.

The clinical program for many 505(b)(2) drug development programs is often ahead of the formulation development, analytical methods development and up-scale activities. For this reason, some pharma sponsors of the clinical drug submission accept the risk and scale up early in Clinical Phase 1 Study.

However, while in Clinical Phase 1, to mitigate risk, prudent comparability protocols must be included which can answer a lot of questions and help to minimize risk.