Mastering Complex Regulatory Requirements for Combination Drugs with Thorough Test Plans
Time: 4:30 pm
day: Conference Day One
Details:
- Alternative in vitro approach to clinical endpoint studies for suspension based nasal products
- Identifying the essential regulatory requirements for developing a comprehensive test program for combination drugs
- Strategies for seamlessly formalizing test programs and moving beyond human factor testing to ensure box-to-disposal safety
- Addressing less traditional safety considerations, including the potential risks associated with blood-brain barrier pathogen piggybacking, in the testing of combination drugs
- Reviewing design history file requirements for nasal drug delivery components considering nasal spray as a combination drug
