Computer Modeling - In vitro and In vivo Studies
Computer modeling and simulation can be very useful tools to accelerate product development and reduce costs. They allow reduction in the use of animals or human volunteers, speed up the collection and evaluation of data, and allow alteration of variables that are not easily changed in vivo.
The workshop will consist mainly of discussion of case studies where a computer modeling/simulation tool was used to evaluate data collected from dissolution, intrinsic dissolution, fluid dynamics evaluation, bioassays, etc. Also, regulatory expectations when submitting data obtained from computer modeling/simulations to regulatory agencies will be discussed.
Who Should Participate?
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Deirdre M. D’arcy, Trinity College of Dublin
- Ene Ette, Anoixis Corporation
- Susan Ewing, Pfizer
- Humberto Ferraz, University of Sao Paulo
- Nikoletta Fotaki, University of Bath
- Sara Franceschi, GSK
- David Good, Bristol-Meyers Squibb
- Guenther Hochhaus, University of Florida
- Edmund Kostewicz, Goethe University
- Raimar Loebenberg, University of Alberta
- Margareth Marques, USP
- John Mauger, University of Utah
- Amitava Mitra, Sandoz, Inc.
- Jasmina Novakovic, Apotex Inc.
- Devendra Pade, Simcyp Limited (A Certara Company)
- Alan Parr, BioCeutics, LLC
- James E. Polli, University of Maryland
- Dennis Sandell, S5 Consulting
- David C. Sperry, Eli Lilly
- David Turner, Simcyp Limited (A Certara Company)
- Maria Vertzoni, University of Athens
- Herbert Wachtel, Boehringer Ingelheim
- Hu Wang, Merck
- Meng Wang, CDER, U.S. FDA
- Jane Weitzel, Independent Consultant
- Xinyuan (Susie) Zhang, CDER, U.S. FDA
Software Exhibitor Opportunities
Vendors are invited to participate in the workshop to demonstrate any software or equipment that can be used in computer modeling for procedures such as dissolution, disintegration, drug release, solubility determination, particle size distribution, in vitro performance tests, etc. Table tops will be open during various networking breaks for live demonstrations. Please see the attached Exhibitor Signup Information form for more information.
Advance Registration Deadline
Advance registration will be available through October 19, 2017. After that date, registration will be available on site at the USP Meetings Center.
Please note that registering for a USP event requires an Access Point account. Please follow the instructions after clicking the “Register” button.
Registration is payable by credit card only. Registration fee includes the full two-day program, meeting materials, coffee breaks, lunches, and a networking reception. Registration fees for this workshop have been set as follows:
Regular Fee Per Person
Early Bird Discount
When registering colleagues (not yourself), please create your own Access Point account and then check the “I am registering others – not myself” box at the top of the registration form. If you are registering multiple people, please select “add additional registrants” on the final page of the registration form (before submitting payment).
Cancellation and Substitution Policy
Cancellation must be received on or before October 2, 2017 (21 days prior to the event) via email to email@example.com. Refunds will not be issued for cancellations received after this date. There is a $50.00 processing fee on all cancellations; however, it is permissible to send a substitute registrant from your same organization. Substitutions must be submitted in writing via email to firstname.lastname@example.org.