ASAPprime® Regulatory Interface
ASAPprime® is used in conjunction with, or as a replacement for, traditional ICH or accelerated stability studies.
There have been over 100 regulatory filings using ASAPprime®. Of these, the majority have been for INDs/IMPDs. However, there have been a number of regulatory submissions filed for new market applications and for post-approval changes.
ASAPprime® has been successfully used in place of traditional stability, in support of use-period assignments for INDs for many country authorities including the USA FDA.
Among the countries that have accepted this are: Belgium, Brazil, Bulgaria, Canada, China, Denmark, Egypt, Finland, France, Georgia, Hungary, India, Ireland, Italy, Lebanon, Netherlands, Poland, Portugal, Russia, Spain, Sweden, Taiwan, Turkey, UK, & Ukraine.
Late stage minor changes have been justified by ASAPprime® as part of NDA filings. ASAPprime® modeling is first validated against the prior ICH data for the product before the change, then ASAPprime® is used to show that the stability does not vary with the change. This allows ASAPprime® to bridge data before and after a process, formulation, or other change.
ASAPprime® has been successfully used to justify post-approval changes of products that would normally require new stability programs (e.g., a reduction in package protection).
As an example, an alternative low strength of a marketed tablet product used ASAPprime® in combination with only 3 months of traditional stability. A 3-year shelf-life was accepted with no questions in the US, UK, France, Italy, Turkey, Egypt, Lebanon, and Kenya.
With generics, ASAPprime® justifies equivalence to the originator.
ASAPprime® can model the impact of excursions, and thereby provide justification for acceptability of products subjected to even harsh conditions for short times.
For more information, see the following resources:
F. Qiu, et al. “Accelerated Predictive Stability: Fundamentals and Pharmaceutical Industry Practices”
This book discusses many aspects of ASAP, with case studies.
F. Qiu “Regulatory Updates: IQ Risk-Based Predictive Stability Regulatory Sub-Team”
Boehringer Ingelheim Pharmaceuticals
Presented at Science of Stability Conference, Boston, Massachusetts, October 2018