This three-day, hands-on course provides a working knowledge of the basic theories and application of state-of-the-art simulation and modeling 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, PBPK/PD and DDIs of particular drugs and dosage forms.
You will understand and learn to recognize potential interactions among such factors as:
pKa – ionization effects on solubility, dissolution, permeability and absorption
Solubility and permeability changes in the various environments in the gastrointestinal tract
Differences in physiology between human and preclinical species
Potential for drug degradation in the lumen
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
You will gain basic experience with:
Predicting drug properties from chemical structures using the ADMET Predictor™ Module
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
Fitting nonlinear metabolism and transport models
Estimating steady-state and dynamic DDIs
Building PBPK/PD models using simulated target tissue concentrations
Simulating populations including selected mixes of ages, gender ratios, and ethnicities
Running virtual crossover trials to predict bioequivalence
Deconvoluting in vivo dissolution to generate more useful IVIVCs
Modeling the in vivo exposure of large molecules (biologics)
Understanding optimization methods, objective function weighting, and constraints
Time:
March 7-9, 2016 (8:30AM-5:00PM)
Venue:
DoubleTree by Hilton San Francisco Airport North (Brisbane, CA)
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:
$1200 (industry) or $600 (academic/government).
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.
