Professor Alain BousquetMélou and colleagues propose a new 5day workshop on PK/PD modelling. The workshop will be held in Toulouse from Monday 27 June to Friday 1st July 2016. There is a maximum of 25 places available. Please find the provisional program here.
This 5day workshop is designed for ECVPT residents, PhD students and professionals in academia, industry, or regulatory authorities, working in veterinary pharmacology who wish to improve their pharmacokinetic, toxicokinetic and pharmacodynamic modelling skills. The workshop includes a combination of lectures aiming at presenting key technical and theoretical modelling issues. The content presented and discussed in the lectures will then be illustrated by a series of computerbased handson case studies.
The handson exercises will be performed in roundtable setting. All participants are required to bring their own laptop computer. The participants will be guided through the exercises by instructors with the help of an overhead projector. Active participation in discussions in class is essential.
If you are interested in attending please fill up the registration form available here. This is not a guarantee of a place at the workshop. Registration confirmation will be sent out and payment in full must be received 3 weeks before starting date.
DAY1  Monday

08:309:00


Meet & Greet – An overview of the course

ALAIN BOUSQUETMELOU

09:0010:30

Lecture 1

Linearity vs. Nonlinearity & Linear vs. nonlinear regression: The goal is to introduce the main basic statistical concepts that will be used during the course.

DIDIER CONCORDET

10:3011:00

Morning break, coffee

11:0012:00

Lecture 2

Bioanalytical method validation for pharmacokinetic studies; Statistical methods to test linearity, accuracy, precision, agreement of an analytical technique

Marlene LACROIX

12:0013:30

Lunch

13:30:15:00

Exercise 1

Working with different softwares: Introduction to Excel® & Phoenix®. Review of the Phoenix data processing, plotting, computation and exporting results in Excel and Words, templates

PIERRELOUIS TOUTAIN and others

15:0016:00

Exercise 2

Validation of bioanalytical methods
Notion of residuals, weighting factors as proposed by Phoenix/WNL but also 1/X and 1/X^2 using a user vector, back calculations, including with an equation having a quadratic components etc.

PIERRELOUIS TOUTAIN and Marlene LACROIX

16:0016:30

Afternoon break, coffee

16:3018h

Exercise 2

Continued


DAY2  Tuesday

8:3010:00

Lecture 3

Body clearance: an overview

PIERRELOUIS TOUTAIN

10:0010:45

Lecture 4

Halflife: an overview

PIERRELOUIS TOUTAIN

10:4511:15

Morning break, coffee

11:1512:00

Lecture 5

Volume of distribution: an overview

ALAIN BOUSQUETMELOU

12:0013:30

Lunch

13:30:14:30

lecture 6

Bioavailability (rate and extent ): protocols (plasma, urine, metabolites), estimation, interpretation

ALAIN BOUSQUETMELOU

14:3015:00

Lecture 7

Modeling: goal, main concepts, usefulness, limits ….of different classes of PK models (The primary goal is to review 1 and multicompt models

PIERRELOUIS TOUTAIN

15:0016:00

Exercise 3

Phoenix WinNonlin: one compartment model , IV dosing and oral dosing

PIERRELOUIS TOUTAIN and others

16:0016:30

Afternoon break, coffee

16:3018:00

Exercise 3

continued


DAY3  Wednesday

8:309:30

Lecture 8

Estimation of Withdrawal times

AUDE FERRAN

9:3010:30

Lecture 9

Dose linearity vs. dose proportionality

PIERRELOUIS TOUTAIN

10:3011:00

Morning break, coffee

11:0012:00

Exercise 4

Computation of a withdrawal period for meat (EU approach) using the EMA software (WT 1.4 by P Heckman)

PIERRELOUIS TOUTAIN and AUDE FERRAN

12:0013:30

Lunch

13:30:15:00

Exercise 5

Doselinearity and doseproportionality using a real data set.

PIERRELOUIS TOUTAIN

15:0015:30

Afternoon break, coffee

15:3016:30

Lecture 10

Non compartmental analysis

ALAIN BOUSQUETMELOU

16:3018:00

Exercise 6

Noncompartmental analysis of the kinetic of drug disposition and physiological interpretation of the results

ALAIN BOUSQUETMELOU

DAY4  Thursday

9:0010:00

Lecture 11

Bioequivalence & presentation of the last veterinary EMA guideline:

PIERRELOUIS TOUTAIN

10:0010:30

Morning break, coffee

10:3012:00

Exercise 7

Bioequivalence Analysis: practical class on design and analysis of bioequivalence studies

PIERRELOUIS TOUTAIN

12:0013:30

Lunch

13:3016:00

Exercise 8

Use of Phoenix for more complex model analysis: The case of a Onecompartmental model with Simultaneous IV, oral and IM dosing for a new antibiotic in pigs

PIERRELOUIS TOUTAIN and others

16:0016:30

Afternoon break, coffee

16:3018:00

Exercise 9

Deconvolution analysis vs. modeling to document process of a drug absorption. How to simulate a single compartmental model with two rate constants of absorption (model build with differential equations) , introduction of a noise in the data set and how to use deconvolution to reestimate the rate constant from the simulated data set

PIERRELOUIS TOUTAIN

19:30

Workshop diner

DAY5  Friday

09:0010:00

Lecture 12

Plasma protein binding: an overview

ALAIN BOUSQUETMELOU

10:0010:30

Morning break, coffee

10:3012:00

Exercise 10

Estimation of Bmax, Kd and NS using linear and nonlinear regression.

PIERRELOUIS TOUTAIN

12:0013:30

Lunch

13:3016:00

Exercise 11

How to build a rather advanced model using the Graphical model editor of Phoenix

PIERRELOUIS TOUTAIN

16:0016:30

Afternoon break, coffee

16:3017:00


End of the workshop and debriefing

ALAIN BOUSQUETMELOU

