SIF - Società Italiana di Farmacologia "SIF - Congressi e Meetings"
Department of Anatomy, Farmacology, and Forensic Sciences
Medical School - University of Torino
Italian Society of Pharmacology
POPULATION PHARMACOKINETIC
WEEK
AT THE UNIVERSITY OF TORINO
March 19-22 2002 - Torino Italy
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First Italian Symposium on Population Pharmacokinetic - March 19 Villa Gualino - Viale Settimio Severo 65, 10133 Torino |
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Hands-on Workshop - March 20-22 Principles of Pharmacokinetics - Parametric and Non-Parametric Population PK and PD Modelling and its Apllication to Therapeutic Drug Monitoring: WIN-USC*PACK Computer Classroom - School of Medicine Via Michelangelo 32, 10125 Torino |
First Italian Symposium on Population Pharmacokinetic
March 19 - 2002
Villa Gualino - Viale Settimio Severo 65, 10133 Torino
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Official Language: English
Admission: free
Registration: please send an e-mail or a Fax to the Organizing Secretary
Housing Information: Please contact Miss Silvia Pasquini CO.AL.PI Phone +39 011 5613760 Fax +39011 5621738 E-mail: hotelres@hotelres.it
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Chairman Prof. Mario Eandi MD - mario.eandi@unito.it Department of Anatomy, Pharmacology, and Forensic Sciences Via P. Giuria 13, University of Torino – Italy
Organizing Secretary Roberto Passera, PharmD - roberto.passera@tin.it Gian Paolo Zara MD - gianpaolo.zara@unito.it Department of Anatomy and Pharmacology Via P. Giuria 13, University of Torino - Italy Phone: +39 011 6707803 Fax: +39 011 6707788
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PROGRAM
(Printable PDF version: click here)
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9.00 |
Opening Remarks: Trends and Perspectives of the Population Approach in Pharmacology and Clinical Practice - Prof. M. Eandi |
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I session Chair: Prof. M. Furlanut – Prof. I. Bondareva |
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9.15 |
Population Modelling – Prof. D.Verotta |
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9.40 |
Non Parametric Model Analysis – Prof. R. Jelliffe |
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10.05 |
PK-PD Population Analysis – Dr. R. Gomeni |
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10.30 |
Coffee Break |
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11.00 |
Applications of the Parzen Method to Population Analysis - Dr. M. Costa |
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11.25 |
Markov Chain Monte Carlo Methods in Population Analysis Prof. G. De Nicolao e Prof. P. Magni |
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11.50 |
Population PK in Preclinical Drug Development - Dr. I. Poggesi |
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12.15 |
General Discussion |
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13.00 |
Lunch |
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II session Chair: Prof. M. Del Tacca – Prof. R. Jelliffe |
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| 14.00 | Optimising Drugs in Infectious Diseases - Prof. R. Jelliffe |
| 14.20 | Individualising Therapy in Infectious Diseases - Prof. M Furlanut, Dr. F. Pea |
| 14.40 | Optimising Drugs in Neuropsychiatry - Prof. I. Bondareva |
| 15.00 | Genetic and Environmental Factors Causing Variability in the Pharmacokinetics of Psychotropic Drugs - Prof. E. Spina |
| 15.20 | Coffee Break |
| 16.00 | Optimising Transplant Chemotherapy - Prof. N. O. Hoem |
| 16.20 | Optimising Drugs in Cancer Chemotherapy - Dr. Bleyzac |
| 16.40 | Individualising Cancer Chemotherapy – Prof. R. Danesi |
| 17.00 | New Approaches in Dose Optimization of 5-Fluorouracil - Dr. M. Gusella, Prof. R. Padrini |
| 17.20 | Optimising Drugs in Cardiology - Prof. R. Jelliffe |
| 17.40 | Individualising Anticoagulant Therapy – Dr. M.G. Scordo, Prof. R. Padrini, Prof. E. Spina |
| 17.40 | General Discussion and Closing remarks |
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International Invited Speakers: |
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Nathalie Bleyzac, Pharm.D Hospital Debrousse, Lyon, France
Irina Bondareva, Ph.D Laboratory of Mathematical Medicine Institute for Physical and Chemical Medicine Moscow, Russia
Nils Ove Hoem, Ph.D. Associate Professor of Pharmacology, Department of Pharmacology - School of Pharmacy University of Oslo, Norway
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Roger Jelliffe, M.D. Professor of Medicine Division of Geriatric Medicine Director, Laboratory of Applied Pharmacokinetics School of Medicine - University of Southern California - Los Angeles USA
Davide Verotta Associate Professor Department of Biopharmaceutical Sciences School of Pharmacy - University of California S. Francisco USA
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Principles of Pharmacokinetics - Parametric and Non-Parametric Population PK and PD Modelling and its Application to Therapeutic Drug Monitoring: WIN-USC*PACK
Hands-on Workshop - March 20-22 - 2002
Computer Classroom - School of Medicine
Via Michelangelo 32, 10125 Torino
(Printable PDF version: click here)
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Official Language: English
Admission to the Workshop: free – The number of the participants is limited to 30. The place is assigned on a first-come, first served basis.
Registration to the Workshop: please send an e-mail or a Fax to the Organizing Secretary
Housing Information: Please contact Miss Silvia Pasquini CO.AL.PI Phone: +39 011 5613760 Fax : +39011 5621738 E-Mail: hotelres@hotelres.it
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Chairmen: Roger Jelliffe, M.D., Professor of Medicine, USC School of Medicine, Director, USC Laboratory of Applied Pharmacokinetics
Mario Eandi , M.D., Professor of Clinical Pharmacology, Medical School - University of Torino
Organizing Secretary Roberto Passera, PharmD Gian Paolo Zara MD Phone: +39 011 6707803 Fax: +39 011 6707788
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Main Teacher: Prof. R Jelliffe
Faculty:
Nathalie Bleyzac, Pharm.D, Hospital Debrousse, Lyon, France
Nils Ove Hoem, Ph.D, School of Pharmacy, University of Oslo, Norway
Roger Jelliffe, M.D., USC School of Medicine, Los Angeles, USA
Irina Bondareva, Ph.D., Institute of Physical and Chemical Medicine, Moscow Russia
This course is intended for physicians, pharmacists and biomedical scientists with an interest in population pk/pd 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.
PROGRAM
(Printable PDF version: click here)
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Day 1 - Basic Pharmacokinetics, Introduction to Population Modelling, and Clinical Applications |
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9.00 AM |
Welcome - Prof. M. Eandi |
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9.15 |
Introduction to basic concepts in pharmacokinetics, including Review of Basic Pharmacokinetic Behavior. Drug Elimination and Renal Function - Prof. R. Jelliffe |
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9.30 |
Evaluating Renal Function – Prof R. Jelliffe |
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9.45 |
Bayes' Theorem and the Bayesian Scenario of Planning, Monitoring, and Adjusting Drug Dosage for patients - Dr. Jelliffe |
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10.00 |
Introduction to Population Modeling - Dr. Jelliffe Why model? For description? For action? Traditional Data Fitting Methods Linear regression, NLLS, Bayesian |
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10.30 |
Break |
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10.45 |
Parametric Population Models (Iterative 2 stage Bayesian, NONMEM )- Dr. Jelliffe |
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11.15 |
Nonparametric Population models (NPML, NPEM) - Dr. Jelliffe |
| 11.45 | Nonparametric Adaptive Grid (NPAG) Modeling - Dr. Jelliffe |
| 12.30 | Lunch |
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1.30 PM |
Comparing Parametric and Nonparametric Approaches (IT2B, NPEM, NPAG) - Dr. Jelliffe |
| 2.00 | Multiple Model (MM) Dosage Design for maximum precision regimens - Dr. Jelliffe |
| 2.30 | Getting MM Bayesian Posterior Individual Parameter Distributions. The Interacting MM (IMM) Approach - Dr. Jelliffe. |
| 3.00 |
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. |
| 3.15 | Break |
| 3.30 | Entering past doses and levels, analysing the data. A patient on Gentamicin. An interesting patient on Tobramycin. - Dr. Jelliffe |
| 4.00 |
Hands on session - Dr. Jelliffe The patient on Gentamicin. The interesting patient on Tobramycin |
| 4.30 |
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 |
| 5.00 |
Hands on session - Setting the initial goals, planning the initial regimen The simpler patient with atrial fib |
| 5.30 | Demo Vancomycin - Setting the initial goals, planning the initial regimen. - Dr. Jelliffe |
| 5.45 | Hands on session - Setting the initial goals, planning the initial regimen |
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Day 2 - Intermediate Population Modeling |
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9.00 AM |
Optimizing drugs in neuropsychiatry - dr. Bondareva |
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9.30 |
Individualization of Busulfan Therapy in Children for Bone Marrow Transplantation - Dr. Bleyzac |
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10.00 |
Optimal procedures for population modeling - Dr. Jelliffe 1) determine the assay error pattern polynomial, to weight each data point properly 2) use a parametric population model, get gamma, ranges 3) use an NP population model, use gamma, ranges, get the entire parameter distribution. |
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10.30 |
Demo - getting the assay error polynomial - Dr. Jelliffe |
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10.45 |
Hands - on session - getting the assay error polynomial |
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11.00 |
Break |
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11.15 |
Demo - The IT2B program. Modelling Amikacin - Dr. Jelliffe A typical patient data file: Running the program. Getting gamma, ranges, evaluating the results |
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11.45 |
Hands-on session Modeling Amikacin. Running the program. Getting gamma, ranges, evaluating the results |
| 12.30 | Lunch |
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1.30 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 |
| 2.15 |
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 |
| 3.00 | Break |
| 3.15 | Optimal Times to Sample Serum Concentrations and other Responses - Dr. Jelliffe. |
| 4.15 | Making Discrete "Nonparametric" Population Models from Literature Data - Dr. Jelliffe. |
| 4.45 | 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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9.00 AM |
Modeling Cyclosporine - Dr. Hoem |
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9.30 |
Making large and nonlinear population models - Dr. Jelliffe Demo - Using BOXES making a model of Cyclosporine |
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10.15 |
Hands on session - Using BOXES making a model of Cyclosporine - Dr. Jelliffe |
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10.45 |
Break |
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11.00 |
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 |
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11.30 |
Hands-on session - setting up big IT2B - Modelling Cyclosporine. Setting up the model, the data, sending it, analysing it, Evaluating the results |
| 12.30 | Lunch |
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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 |
Hands-on session - Big NPEM Modelling Cyclosporine Setting up the model, the data, sending it, analyzing it, Evaluating the results |