Cutting Edge Approaches for Demonstrating Bioequivalence

  • Thursday, April 16, 2020
  • Friday, April 17, 2020
  • 1750 Rockville Pike, Rockville, Maryland 20852-1699

Registration


Registration is closed

Scientists Advancing Affordable Medicines, Inc. is excited to present a two-day event on transforming generic drug R&D using cutting edge approaches.

Event Highlights:

  • Scientific committee co-chaired by SAAMnow and FDA
  • Key note speakers on transforming generics R&D and use of model informed drug design for BE
  • Well represented by multiple FDA offices as speakers/panel-members/moderators
  • Panel discussions after each session with speakers and experts

Day 1 of the event will focus on:

  1. Advances in Characterization Based Equivalence (CBE) for Topicals, Ophthalmics, Orally Inhaled Drug Products and Long Acting Injectables

  2. Progress with novel methodologies/PBPK models in establishing BE when there are compositional or Q3 differences with the RLD

Day 2 of the event will focus on:

  1. Novel BE methods and designs for clinical endpoint studies, sparse PK data, and discussion on Bayesian approach

  2. Using Model Informed Evidence (MIE) for product development ad approval. Case studies will illustrate the benefits of modeling and simulation for generic product developments and developing Q1-Q3 design space.


Agenda
Sponsorship Opportunities

Hotel Information

Hotel Name:
Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr

Hotel Address:
1750 Rockville Pike
Rockville, Maryland 20852-1699

Phone Number:
3018501100

Group Name:
SAAMnow Spring 2020 Conference

Group Code:
ASAAM

Check-in:
15-APR-2020

Check-out:
17-APR-2020