Workshop is fully booked.
 

This 5-day course is designed to provide a strong working knowledge of state-of-the-art methods for dealing with some of the most complex issues that affect many development projects for orally dosed drugs. A combination of presentations and interactive examples, taken from actual industry experience and using GastroPlus, will provide a description of concepts and illustrate how to recognize and deal with intricate phenomena that affect particular drugs or dosage forms.

Who should attend?

This workshop is appropriate for pharmaceutical/biotechnology scientists in the areas of DMPK, ADME, preformulation/formulation development, biopharmaceutics, and clinical pharmacology and pharmacokinetics. This is an advanced course, so experience with GastroPlus is required. Attendees should be familiar with the basics of setting up support files and running GastroPlus simulations prior to arriving in Durango, as this material will not be covered. The course will use GastroPlus for all case studies, but the guiding principles will be taught in a software-independent manner. To encourage interactions with the course instructors and among attendees, we are limiting the class size to twenty (20) participants.

What will you learn?

Upon completion of this course, you should understand the potential complexities of modeling drug absorption, pharmacokinetics (including physiologically based pharmacokinetics - PBPK), and pharmacodynamics.

You will understand and know how to recognize interactions among such factors as:

• pKa – ionization effects on dissolution and absorption

• location-dependent solubility and permeability

• transit times through various gut regions

• degradation in the lumen

• metabolizing enzymes in the gut wall and in other tissues

• influx and efflux transporters in the gut wall and in other tissues

• renal clearance and its variables

• drug-drug interactions (both metabolic and transporter-based)

• food effects

• enterohepatic circulation

• formulation effects

• species differences

You will gain experience with:

• generating predictions of drug properties from chemical structure

• identifying when to use PBPK vs. standard compartmental PK

• predicting first-in-human doses with available preclinical and in vitro data

• assessing various formulation strategies to guide future development

• fitting complex nonlinear metabolism and transport models

• understanding optimization, including objective function weighting effects

• tracking parent and metabolite concentrations in plasma and tissues

• building PK/PD models with target tissue concentrations

• applying population simulations in early development

• deconvoluting in vivo dissolution to generate IVIVCs

How will the workshop operate?

The workshop will consist of presentations and interactive seminars using GastroPlus. All presentation slides will be available in hard-copy format. Laptop computers will be provided with GastroPlus preloaded along with all data files needed to run the case studies. Students will also receive a complimentary 30-day license to GastroPlus for use at their home organization after the workshop.

Continental breakfast, refreshment breaks, and lunch will be provided each day.

When and where will this be held?

The workshop will be held October 4-8, 2010 in Durango, Colorado at the Doubletree Hotel Durango. Durango is a scenic, historic town in the Southwest corner of Colorado. The city is nestled in the Animas River Valley surrounded by the San Juan Mountains. Early October is usually the season of spectacular fall color. Durango is popular for many outdoor activities, such as hiking, mountain biking, rock climbing, year-round fishing, rafting, kayaking, and golfing. The Indian cliff dwellings of Mesa Verde National Park, and Canyon of the Ancients, are just a short drive away.

The Doubletree Hotel Durango is downtown Durango's premier hotel. Enjoy scenic views and be within walking distance of numerous shopping and restaurant options. A special room rate is available for attendees of the workshop.

What is the cost?

The cost for this 5-day course is $2,990 (USD). This fee covers all training materials, continental breakfast, refreshment breaks, and lunch each day. Hotel accommodation is not included with the registration, but special room rates are available through Doubletree Hotel Durango.

For more information and to reserve your place at this event, please contact:

Ms. Renee Bouche

renee@simulations-plus.com

International: +1-661-723-7723 ext. 227

Toll-free in U.S. and Canada: 888-266-9294 ext. 227