Full Programme Final
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1st Workshop on Pharmacokinetic/Pharmacodynamic Modeling
“Basic PK/PD modeling concepts and the role and utility of PK/PD in drug development”
December 7-8, 2009 e
ec e r G , s a r t a P
Workshop Organiser: Dr. Gregory B. Sivolapenko, Laboratory of Pharmacokinetics, Department of Pharmacy, University of Patras, Patras, Greece
Workshop Tutors: Dr. Dan Weiner, Pharsight, USA & Dr. Gregory B. Sivolapenko, Dept. of Pharmacy, University of Patras, Greece
Venue: Conference Centre, University of Patras Campus, Patras, Greece
Language: English
Organising Committee: I. Adamopoulos, Director, Clinical Haematology, Kalamata General Hospital, Kalamata E. Briassoulis, Assoc. Professor, Dept. of Medical Oncology, University of Ioannina, Ioannina P. Cordopatis, Professor, Dept. of Pharmacy, University of Patras, Patras C. Flordellis, Professor, Dept. of Medicine, Lab. of Pharmacology, University of Patras, Patras C. Gogos, Professor, Dept. of Medicine, Division of Infectious Diseases, University of Patras, Patras H. Kalofonos, Professor, Dept. of Medicine, Division of Oncology, University of Patras, Patras A. Papapetropoulos, Professor, Dept. of Pharmacy, University of Patras, Patras G. Sivolapenko, Assoc. Professor, Dept. of Pharmacy, University of Patras, Patras D. Skarlos, Director, Dept. of Oncology, Metropolitan Hospital, Piraeus
Scientific Committee: V. Anastasopoulos, Professor, Dept. of Physics, University of Patras, Patras G. Fountzilas, Professor, Dept. of Internal Medicine, Section of Oncology, University of Thessaloniki, Thessaloniki N. Karamanos, Professor, Dept. of Chemistry, University of Patras, Patras D. Kardamakis, Assoc. Professor, Dept. of Radiation Oncology, University of Patras, Patras D. Pectasides, Professor, Dept. of Internal Medicine, Oncology Section, University of Athens, Athens K. Tsatalas, Professor, Dept. of Medicine, Haematology Section, University of Thrace, Alexandroupolis I. Varthalitis, Director, Dept. of Oncology, Chania General Hospital, Chania
Local Organising Committee - Secretariat: Dr. I. Leontari, C. Liolios, MSc, I. Panoilia MSc., Lab. of Pharmacokinetics, Dept. of Pharmacy, University of Patras, Patras.
Participation: A limited number of participants will be accepted at the workshop
Registration: FREE for the successful applicants, following review by the Scientific Committee. Free registration includes: workshop material, lunches, workshop dinner, hotel accommodation and travel allowance (for non-Patras residents).
Application: Please send your CV and a short cover letter to: Dr. G. Sivolapenko, [email protected], by November 16, 2009.
Information: Dr. G. B. Sivolapenko, Tel.: +30 2610 969816, Fax.: +30 2610 996302, e-mail: [email protected]
WORKSHOP PROGRAMME
1> Monday, December 7, 2009
DAY
09.30-09.45: Introduction What are our expectations Course layout and material Course evaluation forms
09.45-10.15: What is the Critical Path Initiative and its implications for drug discovery and development The business case for modeling and simulation FDA and the Critical Path Initiative EMEA and other initiatives
10.15-11.00: Review of basic pharmacokinetic principles Review of Cl, Vss & t1/2 Steady-state exposure Iv vs extravascular dosing
11.00-11.15: Coffee/Tea break 11.15-12.30: Principles of pharmacodynamics I Review of steady-state models Kinetics of drug action Effect compartment models (demo of Link library) Initial parameter estimates Design issues and case studies
12.30-13.00: Overview of pharmacokinetic/pharmacdynamic modeling using WinNonlin’s newly released v. 6 13.00-14.00: Lunch break 14.00-15.00: Basic statistical issues in modeling Weighting Model discrimination Goodness of fit
15.00-15.15: Coffee/Tea break 15.15-16.00: Basic WinNonlin v6 training How to create data files, plots and workflows Model libraries
16.00-17.00: Practical exercise 1 One compartment bolus vs iv dosing Going from data to insight How to use WinNonlin model libraries
17.00-18.00: Strategies for dose selection for first-in-man studies 20.30:
Workshop dinner
WORKSHOP PROGRAMME
2> Tuesday, December 8, 2009
DAY
08.30-08.45: Wrap-up Day 1 08.45-10.00: Principles of pharmacodynamics II Basic concepts on turnover delays Initial parameter estimates Design issues and case studies
10.00-10.15: Coffee/Tea break 10.15-12.00: Practical exercise 2 Pharmacokinetic/pharmacodynamic modeling using an effect compartment Fit an effect compartment to iv bolus data using WinNonlin’s libraries Simulate the time course of the effect compartment to select optimal dose and regimen
12.00-13.00: Lunch break 13.00-14.00: Combining several sources of data Combining results from several subjects An introduction to modeling when data on multiple subjects are available
14.00-14.15: Coffee/Tea break 14.15-15.15: Experimental design: how to select sampling times Rich data Destructive sampling strategies and population sampling designs
15.15-16.15: Practical exercise 3 Turnover models: warfarin dynamics Strategies for modeling pharmacodynamic time delays
16.15-17.00: Case studies illustrating the value of modeling and simulation
“Basic PK/PD modeling concepts and the role and utility of PK/PD in drug development”
December 7-8, 2009 e
ec e r G , s a r t a P
Workshop Organiser: Dr. Gregory B. Sivolapenko, Laboratory of Pharmacokinetics, Department of Pharmacy, University of Patras, Patras, Greece
Workshop Tutors: Dr. Dan Weiner, Pharsight, USA & Dr. Gregory B. Sivolapenko, Dept. of Pharmacy, University of Patras, Greece
Venue: Conference Centre, University of Patras Campus, Patras, Greece
Language: English
Organising Committee: I. Adamopoulos, Director, Clinical Haematology, Kalamata General Hospital, Kalamata E. Briassoulis, Assoc. Professor, Dept. of Medical Oncology, University of Ioannina, Ioannina P. Cordopatis, Professor, Dept. of Pharmacy, University of Patras, Patras C. Flordellis, Professor, Dept. of Medicine, Lab. of Pharmacology, University of Patras, Patras C. Gogos, Professor, Dept. of Medicine, Division of Infectious Diseases, University of Patras, Patras H. Kalofonos, Professor, Dept. of Medicine, Division of Oncology, University of Patras, Patras A. Papapetropoulos, Professor, Dept. of Pharmacy, University of Patras, Patras G. Sivolapenko, Assoc. Professor, Dept. of Pharmacy, University of Patras, Patras D. Skarlos, Director, Dept. of Oncology, Metropolitan Hospital, Piraeus
Scientific Committee: V. Anastasopoulos, Professor, Dept. of Physics, University of Patras, Patras G. Fountzilas, Professor, Dept. of Internal Medicine, Section of Oncology, University of Thessaloniki, Thessaloniki N. Karamanos, Professor, Dept. of Chemistry, University of Patras, Patras D. Kardamakis, Assoc. Professor, Dept. of Radiation Oncology, University of Patras, Patras D. Pectasides, Professor, Dept. of Internal Medicine, Oncology Section, University of Athens, Athens K. Tsatalas, Professor, Dept. of Medicine, Haematology Section, University of Thrace, Alexandroupolis I. Varthalitis, Director, Dept. of Oncology, Chania General Hospital, Chania
Local Organising Committee - Secretariat: Dr. I. Leontari, C. Liolios, MSc, I. Panoilia MSc., Lab. of Pharmacokinetics, Dept. of Pharmacy, University of Patras, Patras.
Participation: A limited number of participants will be accepted at the workshop
Registration: FREE for the successful applicants, following review by the Scientific Committee. Free registration includes: workshop material, lunches, workshop dinner, hotel accommodation and travel allowance (for non-Patras residents).
Application: Please send your CV and a short cover letter to: Dr. G. Sivolapenko, [email protected], by November 16, 2009.
Information: Dr. G. B. Sivolapenko, Tel.: +30 2610 969816, Fax.: +30 2610 996302, e-mail: [email protected]
WORKSHOP PROGRAMME
1> Monday, December 7, 2009
DAY
09.30-09.45: Introduction What are our expectations Course layout and material Course evaluation forms
09.45-10.15: What is the Critical Path Initiative and its implications for drug discovery and development The business case for modeling and simulation FDA and the Critical Path Initiative EMEA and other initiatives
10.15-11.00: Review of basic pharmacokinetic principles Review of Cl, Vss & t1/2 Steady-state exposure Iv vs extravascular dosing
11.00-11.15: Coffee/Tea break 11.15-12.30: Principles of pharmacodynamics I Review of steady-state models Kinetics of drug action Effect compartment models (demo of Link library) Initial parameter estimates Design issues and case studies
12.30-13.00: Overview of pharmacokinetic/pharmacdynamic modeling using WinNonlin’s newly released v. 6 13.00-14.00: Lunch break 14.00-15.00: Basic statistical issues in modeling Weighting Model discrimination Goodness of fit
15.00-15.15: Coffee/Tea break 15.15-16.00: Basic WinNonlin v6 training How to create data files, plots and workflows Model libraries
16.00-17.00: Practical exercise 1 One compartment bolus vs iv dosing Going from data to insight How to use WinNonlin model libraries
17.00-18.00: Strategies for dose selection for first-in-man studies 20.30:
Workshop dinner
WORKSHOP PROGRAMME
2> Tuesday, December 8, 2009
DAY
08.30-08.45: Wrap-up Day 1 08.45-10.00: Principles of pharmacodynamics II Basic concepts on turnover delays Initial parameter estimates Design issues and case studies
10.00-10.15: Coffee/Tea break 10.15-12.00: Practical exercise 2 Pharmacokinetic/pharmacodynamic modeling using an effect compartment Fit an effect compartment to iv bolus data using WinNonlin’s libraries Simulate the time course of the effect compartment to select optimal dose and regimen
12.00-13.00: Lunch break 13.00-14.00: Combining several sources of data Combining results from several subjects An introduction to modeling when data on multiple subjects are available
14.00-14.15: Coffee/Tea break 14.15-15.15: Experimental design: how to select sampling times Rich data Destructive sampling strategies and population sampling designs
15.15-16.15: Practical exercise 3 Turnover models: warfarin dynamics Strategies for modeling pharmacodynamic time delays
16.15-17.00: Case studies illustrating the value of modeling and simulation
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