The Importance of DDI Studies to IND Submissions

Envigo will be hosting the next free lunch and learn event with a focus on metabolism studies and recent changes in FDA guidelines. Two experienced scientists from Industry and Envigo will be there to help explain necessary obligations and ensure compliance with new and emerging clinical trial submission guidelines.

Key Questions:

• What are the current DDI guidelines?
• How do the current FDA guidelines impact your program?
• How do you determine if you should perform DDI studies?
• How do you design the appropriate of DDI studies, the data interpretation and evaluation considerations
• Areas where questions still remain – what to do, when to do it, reasonable design, interpretation and implementation
• Choosing the right CRO to conduct these studies
   

Speakers

Mr. Guy Webber
Scientific Manager, In vitro & Drug-Drug Interaction Sciences

Mr. David Reynolds
Consultant, Scientific Advisor, Business Development Lead