This three-day, hands-on course provides a working knowledge of the theories and application of our state-of-the-art PBPK modeling and simulation software for the analysis of drug dissolution and absorption, coupled with the resulting pharmacokinetics and pharmacodynamics. A combination of presentations and interactive examples, taken from actual industry experience and using GastroPlus, illustrate how to recognize and deal with the multiple interacting phenomena that affect the absorption, pharmacokinetics, and DDIs of particular drugs and dosage forms.
Who should attend?
This workshop is appropriate for research scientists and engineers in the areas of DMPK, ADME, preformulation/formulation development, biopharmaceutics, pharmacokinetics, and clinical pharmacology. Prior experience with GastroPlus is not required. The course will use GastroPlus for all case studies, but the guiding principles will be taught in a software-independent manner. Class size is limited to encourage interaction with the course instructors and among attendees. Interaction and networking among industry, government, and academic scientists is an important and valuable part of the experience!
Download the brochure for the workshop here
You will understand and learn to recognize potential interactions among such factors as:
- pKa – ionization effects on dissolution, precipitation, absorption, and distribution
- Solubility and permeability changes in the various environments in the gastrointestinal tract
- Differences in physiology between human and preclinical species
- Transit times through various gut regions and how and why they may vary
- Formulation effects, including particle size distributions and controlled release dosage forms
- Effects of food/mealtimes on physiology and on the drug
- Influx and efflux transporters in the gut wall and in other tissues
- Metabolizing enzymes in the gut wall and in other tissues
- Renal clearance and its variables
- Potential for enterohepatic circulation
You will gain experience with:
- Screening compound libraries for absorption and bioavailability using chemical structures
- Recognizing when to use PBPK vs. standard compartmental PK models
- Predicting first-in-human doses with available preclinical and in vitro data
- Assessing formulation strategies such as micronization and nanoparticles
- Deconvoluting in vivo dissolution to generate more useful IVIVCs
- Simulating populations including selected mixes of ages, gender ratios, and ethnicities
- Predicting complex DDIs – both static and dynamic
- Estimating local concentration of drug following dermal and pulmonary administration
- The effect of food, both positive and negative, on the absorption and pharmacokinetics
- Modeling the distribution of large molecules (biologics) using PBPK approaches
- Understanding optimization methods, objective function weighting, and constraints
Time:
June 8-10, 2016
Venue:
Chungnam National University (Daejeon, South Korea)
Meals/Refreshments/Dress:
Continental breakfast, refreshment breaks, and lunch will be provided each day.
Casual Dress
Registration:
Registration by email or website is required. Space is limited.
Cost:
$395(industry) per person or $200(academic/government) per person.
Includes all workshop materials, continental breakfast, refreshment breaks, and lunch each day. Hotel accommodations are not included with registration. Also, a one (1) month single-user license to GastroPlus, with all optional modules, is available after the workshop.
Co-Sponsors:
Please register by May 20, 2016!
