Table of Contents
Recombinant allergens: what needs to come next?
Where we are with natural allergens
Where we are with natural allergens
Where we are with natural allergens
Where we are with natural allergens - summary
How can we improve the use of natural allergens?
How can we improve the use of natural allergens?
Where we are with recombinant allergens
Where we can be with recombinant allergens
Where we can be with recombinant allergens
Where are we in the process?
How does the FDA decide?
Guidance documents that apply to allergenic products
Guidance documents that apply specifically to recombinant products
How to get there from here
How to get there from here
How to get there from here
IND process
FDA’s objectives in reviewing an IND:
IND - Phase 1
Reasons for “hold” on Phase 1 study
IND - Phase 2
IND - Phase 3
Reasons for “hold” on Phase 2/3 study
IND process
How to get there from here
Study power
How to get there from here
How to get there from here
How to get there from here
But it has been done before...
Resources
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