The USC Laboratory of Applied Pharmacokinetics and the Schools of Medicine and Pharmacy, and the School of Pharmacy, University of Navarra, Spain, are pleased to announce a Three-Day, Hands-on workshop on
Thursday - Saturday, January 24-26, 2002.
Location: The University of Navarra, Pamplona, Spain.
A registration form is available.
For more information, please contact
Azucena Aldaz, Pharm. D.
Servicio de Farmacia, Facultad de Medicina,
Clinica Universidad de Navarra
Avda Pio XII, n 36
31008 Pamplona, SpainPhone: 34-948-296-692, x4113, 4119
Fax: 34-948-175-278
Email: aaldaz@unav.es
This course is intended for physicians, pharmacists and biomedical scientists with an interest in population pharmacokinetic / pharmacodynamic modeling, and also for those interested in therapeutic drug monitoring and optimally precise individualization of drug therapy for patient care.
Prior experience in clinical pharmacokinetics will be an advantage. Participants will be introduced to the USC*PACK software, which can be used both for therapeutic drug monitoring and optimal individualization of drug dosage regimens, as well as for parametric and nonparametric population PK/PD and physiological modeling.
This course will also introduce the new Win*USC*PACK software for "Multiple Model" design of dosage regimens that hit target goals with maximal precision. This method is based first on nonparametric population models. It also obtains a patient's Bayesian posterior nonparametric individual model, and, if needed, to detect and quantify the interoccasional variability in each patient's individual model, thus permitting detection of unsuspected changes in parameter values such as take place with the volume of distribution (and other parameters), in aminoglycoside antibiotics, for example, with changes in the patient's status. This sequential Bayesian "Interacting Multiple Model" Bayesian approach to interoccasional intra-individual variability comes from the aerospace community, where it is used to track evasive targets. It is new, to our knowledge, in the pharmacokinetic community. It is designed to track the behavior of drugs, especially in unstable patients, with maximum precision, to detect unsuspected changes in a patient's parameter values during the period of the data analysis, and to permit achievement of target therapeutic goals with maximum precision.
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Course Co-coordinators:
Azucena Aldaz, Ph.D., Faculty of Pharmacy, University of Navarra
Roger W. Jelliffe, M.D., Professor of Medicine, USC School of Medicine,
Director, USC Laboratory of Applied Pharmacokinetics.
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Faculty:
Nathalie Bleyzac, Pharm.D, Hospital Debrousse, Lyon, France
Aida Bustad, B.A.,USC Laboratory of Applied Pharmacokinetics
George Drusano, M.D., Albany Medical College, Albany, NY, USA
Nils Hoem, Ph.D, School of Pharmacy, University of Oslo, Norway
Roger W. Jelliffe, M.D., Professor of Medicine, USC School of Medicine,
Guest speakers from Valencia
Preliminary Program:
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Day 1 - Basic Pharmacokinetics, Introduction to Population Modeling,
and Clinical Applications
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8:30 AM - Registration
9:00 AM - Welcome Dr. Aldaz
9:15 AM - Introduction to basic concepts in pharmacokinetics, including
Review of Basic Pharmacokinetic Behavior.
Drug Elimination and Renal Function - Dr. Jelliffe
9:30 AM - Evaluating Renal Function Dr. Jelliffe
9:45 AM - Bayes' Theorem and the Bayesian Scenario of Planning,
Monitoring, and Adjusting Drug Dosage for patients - Dr.
Jelliffe
10:00 AM - Introduction to Population Modeling - Dr. Jelliffe
Why model? For description? For action?
Traditional Data Fitting Methods
Linear regression, NLLS, Bayesian
10:30 AM BREAK
10:45 AM - Parametric Population Models - Dr. Jelliffe
Iterative 2 stage Bayesian, NONMEM
11:15 AM - Nonparametric Population models - Dr. Jelliffe
NPML, NPEM
11:45 AM - Nonparametric Adaptive Grid (NPAG) Modeling -
Dr. Jelliffe
12:15 PM - LUNCH
1:15 PM - Comparing Parametric and Nonparametric Approaches - IT2B,
NPEM, and NPAG - Ms. Aida Bustad.
1:45 PM - Multiple Model (MM) Dosage Design for maximum precision
regimens - Dr. Jelliffe
2:15 PM -Getting MM Bayesian Posterior Individual Parameter
Distributions. The Interacting MM (IMM) Approach - Dr.
Jelliffe.
2:45 PM - Introduction to the new Windows USC*PACK MM and IMM
Clinical Program to Achieve Target Goals with Maximum
Precision - Dr. Jelliffe
Demo - 1 compartment model Planning the Initial regimen
- Gentamicin: CCr = 100, 50, 5.
3:00 PM - BREAK
3:15 PM - Entering past doses and levels, analysing the data.
A patient on Gentamicin
An interesting patient on Tobramycin.
3:45 PM - Hands on session - Dr. Jelliffe
The patient on Gentamicin
The interesting patient on Tobramycin.
4:15 PM - Demo - 2 compartment model Digoxin - Dr. Jelliffe
Setting the initial goals, planning the initial regimen
A simple patient with atrial fibrillation
Another interesting patient with atrial fib
4:45 PM - Hands on session - Setting the initial goals, planning the
initial regimen.
The simpler patient with atrial fib
5:15 PM - Demo Vancomycin - Setting the initial goals, planning the
initial regimen. - Dr. Jelliffe
5:30 PM - Hands on session - Setting the initial goals, planning the
initial regimen.
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Day 2 - Intermediate Population Modeling
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8:30 AM - Antiviral Therapy Today - Dr. Drusano
9:00 AM - Individualization of Busulfan Therapy in Children for Bone
Marrow Transplantation - Dr. Bleyzac
9:30 AM - Optimal procedures for population modeling - Dr. Jelliffe
First, determine the assay error pattern polynomial, to
weight each data point properly
Second, use a parametric population model, get gamma,
ranges
Third, use an NP population model, use gamma, ranges, get
the entire parameter distribution.
10:00 AM - Demo - getting the assay error polynomial - Dr. Jelliffe
10:15 AM - Hands - on session - getting the assay error polynomial
10:30 AM - BREAK
10:45 AM - Demo - The IT2B program. Modelling Amikacin - Dr.
Jelliffe
A typical patient data file
Running the program. Getting gamma, ranges, evaluating
the results
11:15 AM - Hands-on session Modeling Amikacin
Running the program. Getting gamma, ranges, evaluating
the results
12:00 Noon - LUNCH
1:00 PM - Demo NPEM: Modeling Amikacin further. Using gamma,
ranges results - Dr. Jelliffe
Evaluating the results - The log-likelihood function
Descriptors of dispersion : The DF50 and DF95
The 2 and 3-D plots of the marginal and joint marginal
PDF's
1:45 PM - Hands-on session - NPEM: Amikacin. Using gamma,
ranges - Dr. Jelliffe
Linking Nonparametric Models to the Multiple Model
Adaptive Control Software
Deriving individual Bayesian posterior patient parameter
joint densities
Evaluating relationships between parameters and covariates
2:30 PM - BREAK
2:45 PM - Optimal Times to Sample Serum Concentrations and other
Responses - Dr. Jelliffe.
3:15 PM - Topic to be Announced - Guest speaker from Valencia
3:45 PM - Making Discrete "Nonparametric" Population Models from
Literature Data - Dr. Jelliffe.
4:15 PM - Population PK/PD Modeling over the web - Dr. Jelliffe
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Day 3 - Advanced Population Modeling - Large and Nonlinear Models
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8:30 AM - Modelling Cyclosporine - Dr. Hoem
9:00 AM - Making large and nonlinear population models - Dr. Jelliffe
Demo - Using BOXES making a model of Cyclosporine
10:00 AM - Hands on session - Using BOXES making a model of
Cyclosporine - Dr. Jelliffe
10:30 AM - BREAK
10:45 AM - Demo setting up Big IT2B Modelling Cyclosporine - Dr.
Jelliffe
A typical subject data file
Setting up the model, the data, the instructions, sending it,
analyzing it. Evaluating the results
11:15 AM - Hands-on session - setting up big IT2B - Modelling
Cyclosporine.
Setting up the model, the data, sending it, analysing it,
Evaluating the results
12:30 PM - LUNCH
1:30 PM - Demo Big NPEM Modelling Cyclosporine - Dr. Jelliffe
Setting up the model, the data, sending it, analyzing it,
Evaluating the results
2:00 PM - Hands-on session - Big NPEM Modelling Cyclosporine
Setting up the model, the data, sending it, analyzing it,
Evaluating the results
3:00 PM - BREAK
3:15 PM - Topic to be Announced - Guest speaker from Valencia
3:45 PM - Topic to be Announced - Guest speaker from Valencia
4:30 PM - Group Discussion and Certificate Presentation.