From: Utilization of risk-based predictive stability within regulatory submissions; industry’s experience
Case study no. | Description | Phase | Material | Submission Content in Addition to Predictive Dataa | Territories | |
---|---|---|---|---|---|---|
Accepted | Questioned | |||||
1 | Setting initial retest period and shelf-life | Phase 1 | Drug substance and oral solution | Limited long-term data for drug substance | Belgium | |
2 | Setting shelf-life of formulation variant | Phase 1 | Tablet | Limited long-term data | USA, UK, France, Italy, Turkey, Egypt, Lebanon, Kenya | |
3 | Setting shelf-life of formulation variant | Phase 1 | Capsule | Limited long-term data | USA | |
4 | Setting initial retest period and shelf-life | Phase 1 | Drug substance and IV solution | None | Netherlands, Germany (drug substance) | UK, Germany (drug product) |
5 | Setting initial retest period and shelf-life | Phase 1 | Drug substance and tablet | None | USA | UK |
6 | Setting initial shelf-life | Phase 1 | Tablet | None | Belgium, Moldova, Bulgaria, Georgia | France, Spain |
7 | Setting initial shelf-life | Phase 1 | Powder for oral solution and tablet | None | Germany | |
8 | Setting shelf-life of formulation variant | Phase 1 | Capsule | None | USA, Spain, France | |
9 | Setting initial shelf-life | Phase 2 | Tablets | None | USA, Belgium | |
10 | Setting initial shelf-life | Phase 2 | Modified release formulation | None | USA, Belgium | |
11 | Setting shelf-life of formulation variant | Phase 2 | Tablet | None | USA, Spain, France | Germany |
12 | Justify storage condition for drug substance with a new process, and predict shelf-life for a new formulation | Phase 2 | Drug Substance and Tablet | Limited long-term data for drug substance, Limited long-term data for drug product | USA | |
13 | Setting shelf-life of formulation variant | Phase 2 | Tablet | Limited long-term data | UK (but with reduced shelf-life) | |
14 | Impact of drug product process change on shelf-life | Phase 3 | Tablet | Limited long-term data | USA, Canada, Russia, Taiwan, Poland, Ukraine, Japan | |
15 | Setting shelf-life of formulation variant | Phase 3 | Capsule | Supportive information from previous formulations | Belgium, Brazil, Canada, China, India, Denmark. Finland, France, Ireland, Italy, Netherlands, Portugal, Spain, Taiwan, Turkey | UK, Korea, Germany |
16 | Justification of strategy for water testing on stability | Registration | Tablet | Predictive dissolution model | USA, EU | |
17 | Justification of degradant end of life specification | Registration | Tablet | Limited long-term data | USA, EU, Canada, Australia, Asia Pacific and Latin America |