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To registration »
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| Who should attend? |
Bioscience, safety, medicinal chemistry and clinical scientists, statisticians, pharmacokineticists, pharmacologists etc.
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| Project Administrator |
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• To raise awareness amongst Bioscience, medicinal chemistry and clinical scientists of what kinetic-dynamic (PKPD) methods can offer
• To raise awareness of the individual steps that make up the dose-plasma-distribution-binding-turnover- response process
• To raise awareness of experimental design. What investment has to be made early and late in discovery?
• To build a case for the assessment of the first time in man dose
• To provide theory and methods of in vivo PK & PD data
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A number of hotel rooms have been booked at the Maritim Hotel München at preferential rates between Wednesday, September 1 - Friday, September 3, 2010. Hotel reservation can be made only when registering for the introduction course to 'Quantitative Pharmacology and PK/PD for Drug Discovery & Development Scientists'. The price for a single room is EUR 140/night including breakfast.
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September 2, 2010
Equilibrium data and models |
| 08.45 |
Registration |
| 09.00 |
1. Introduction and mental contract
• What are our expectations
• Course layout & course material |
| 09.15 |
2. Review of basic PK concepts
• Review of Cl, Vss & t1/2 from a PD point of view
• Steady-state, exposure
• IV vs. extravascular dosing
• Review of basic PPB concepts Cu, C & fu
• When does plasma protein binding matter? |
| 10.15 |
Coffee/tea |
| 10.30 |
4. Pharmacodynamics I (Equilibrium)
• Review of Steady-state models
• Efficacy, potency, specificity and selectivity
• Kinetics of drug action
• Design issues and Case Studies |
| 11.15 |
5. Inter-species scaling
• Review scaling & allometry from a PD point of view
• Why animals differ wrt turnover of drugs
• Why do we build a dose nomogram? |
| 12.15 |
Lunch |
| 13.15 |
5. Groups exercise(s) I
• Selection of a CD based on PK properties |
15.00 -
16.15 |
Wrap-up of the day and the group exercise |
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September 3, 2010
Time delays (Temporal differences) |
| 08.30 |
7. Pharmacodynamics II (Time delays)
• Steady-state models vs. time delay
• Basic concepts on distributional delays
• Turnover concepts and how to model |
| 10.00 |
Coffee/tea |
| 10.20 |
8. Pharmacodynamics III (Our philosophy)
• Project example(s)
• Dose nomogram
• Summarizing the effective concentration range |
| 11.30 |
9. Groups exercise(s) II
• Selection of a CD based on PK/PD properties |
| 12.00 |
Lunch |
| 13.00 |
9. Groups exercise(s) II
Cont. |
| 14.30 |
Summary of Group exercise |
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15.15-
15.30 |
Wrap-up of course |
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• PK from a PD point of view
• PK half-life vs. half-life of response
• The apparent disconnection between PK & PD
• Emax-models and their difficulties if maximum response is lacking
• Effect compartment models in (distribution-rate limited) responses
• Turnover models in (turnover-rate limited) responses
• Receptor on/off binding models in (binding-rate limited) responses
• Scaling pharmacodynamics and PK properties to man
• Practical experimental design of PD studies
• PK&PD assessment at milestone decisions
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| Course Leader |
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Dr Johan Gabrielsson is a Sr. Principal Scientist in the PK/PD section of Discovery DMPK&BAC at AstraZeneca R&D Mölndal, Sweden. He has conducted numerous workshops (more than 3000 participants) on biological (PK/PD) data analysis, for example the popular intermediate and advanced workshops on PK/PD data analysis. Dr Gabrielsson is academically affiliated with the department of pharmacology at University of Gothenburg and is the author of the textbook "Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications", 4th ed. (2006). |
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| Time and Location |
This course will take place on September 2-3, 2010 at the Maritim Hotel München
which is located only a 10-minute walk from the central train station and close to the city’s most famous historical landmarks. In addition to these renowned sightseeing attractions, the hotel’s immediate neighborhood is dominated by an inspiring multicultural atmosphere. Turkish shops offer fresh fruit and vegetables for bargain prices and all sorts of exotic gifts for travelers.
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| Application, Confirmation, Cancellatiion etc |
Early registration is advisable to reserve a place as the number of participants is limited. The early participation fee in the amount of EUR 1050 (excl VAT) is due by July 21 2010, after this date the registration fee is EUR 1260 (excl VAT). The registration fee includes the course documentation, coffee breaks, lunches and a course dinner in the evening of September 2, 2010. The Swedish VAT (25 %) is not included. Non-EU countries and EU countries with a VAT registration number are NOT subject to VAT. If applicable, please state your VAT registration number on the application form. Delegates will be registered upon receipt of the completed form and a first confirmation will be sent by email. Detailed information will be sent out approximately two weeks before the event. The invoice will be sent separately and the payment has to be settled before the start of the course.
Cancellations should be addressed, in writing to Annica Flodin at the Swedish Academy of Pharmaceutical Sciences (Annica.Flodin@Lakemedelsakademin.se)
• Cancellation can be made free of charge until July 21 2010
• Cancellation can be made at an administrative cost of 25% of the participation fee between July 22 and August 4 2010. Room reservation, no refund.
• Cancellation after August 4 2010, no refunds will be made
Substitutions may however be made at any time. Kindly forward the name of the substitute to Annica.Flodin@Lakemedelsakademin.se |
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