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Recorded Webinar
Understanding Bioavailability And Bioequivalence Studies Required for INDs, NDAs and Post-Approval Filings
timelapse 60 Min with 15 Min QnA of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
Bioavailability (BA) and Bioequivalence(BE) Studies submitted for INDs, NDAs and post-approval filings will be discussed during this webinar. BE studies are primarily associated with establishing that a generic product filed in an ANDA is the “same” as the innovator product. However, BE studies, though done for a different purpose, are very often necessary to support INDs, NDAs, and post-approval filings. Information generated from such studies influence the overall clinical development plan and product labeling.
Areas Covered in the Webinar:
- All relevant regulatory requirements for establishing the necessary BA and/or BE studies for INDs, NDAs and supplements to NDAs.
- Differences between BE studies for ANDAs and studies required for INDs, NDAs and post-approval filings.
- Determine the overall clinical development plan and labeling of the product.
- Types of BA and BE studies, including for INDs, as well as pivotal BE studies required to bridge the to-be-marketed formulation
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