K-State Olathe

Day 2 Agenda

 

8:30 a.m. | Welcome and Recap
Rob Hunter, Ph.D., Lead Advisor and Instructor, K-State Olathe

 

8:45 a.m. | Pivotal study stage 2 and 3: Study Initiation and In-life activities (Beth Kee, D.V.M.)

  • Protocol training
  • Implementation and Protocol
  • Monitoring
  • Data Management during this stage

Pivotal study stage 4 and 5: End of live phase and Close Out (Beth Kee, D.V.M.)

  • Animal Accountability
  • Test Article Accountability
  • Data Management at the end of this phase

 

10 a.m. | Break

 

10:45 a.m. | Pivotal study stage 6: Report Writing (Beth Kee, D.V.M.)

  • Data compilation and review
  • Data lock
  • Analysis
  • Report compilation

Pivotal study stage 7: Submission (Beth Kee, D.V.M.)

 

Noon | Lunch

 

12:30 p.m. | Human Food Safety (Rob Hunter, Ph.D.)

  • Bioanalytical Method
  • Reminder of SA data
  • Pivotal Toxicology data
  • Pivotal Comparative Metabolism Data
  • Pivotal Total (HOT) Residue Study
  • Pivotal Marker (Cold) Residue Study
  • Method Trial

2:15p.m. | Break

 

2:30p.m. | Generic Approval/Bioequivalence (Rob Hunter, Ph.D.)

  • Bioanalytical Method
  • Biowaiver
  • Dissolution
  • Solubility
  • Blood level BE
    • PD or Clinical endpoint
  • Residue Study


4:15 p.m. | Wrap‐up and Concluding Remarks

 

4:30 p.m. | Adjourn