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Workshop April 2011

Publié le 4 avril 2011, mise à jour le 25 août 2011
par Alain BOUSQUET-MELOU

Attendees

List of attendees

Evaluation form

Sponsors

Reviews on the main PK parameters

-  Plasma clearance

-  Bioavailability

-  Volume of distribution

-  Half-life

-  Plasma protein binding

Lectures

- Lecture 1 : Simple linear regression

- Lecture 2 : Computation of a withdrawal time and bioequivalence

- Lecture 3 : Dose linearity and dose proportionality

- Lecture 4 : Non-compartemental analysis

- Lecture 5 : Non-linear regression

- Lecture 6 : Pharmacodynamic models

Exercises

Exercise 1

- Study problem 1 : Working with the different softwares (Excel, Winnonlin, Cristal-ball,)

- Exercise 1 : Excel data sheet
- Geometric mean : a review
- Harmonic mean : a review

Exercise 2

- Study problem 2 : Good plotting practices

- Exercise 2 : Excel data sheet

Exercise 3

- Study problem 3 : Validation of bioanalytical methods

- Exercise 3 : Excel data sheet
- Exercise 3 : Excel data sheet for square root finding

Exercise 4

- Sudy problem 4 : Statistical methods to assess agreement between two quantitative methods of measurement (analytical, clinical)

- Exercise 4 :Excel data sheet

Exercise 5

- Study problem 5 : Monte Carlo simulations, Bioequivalence and Withdrawal time

- Exercise 5 : Excel data sheet

Exercise 6

- Study problem 6 : Dose linearity and dose proportionality

- Aticle of Smith et al. (2000) Confidence interval criteria for assessment of dose proportionality. Pharm Res 17:1278–1283

Exercise 7

Study problem 7 : Assessment of the precision of an analytical technique (Repeatability and intermediate precision)

- Exercise 7 : Excel data sheet

Exercise 8

- Study problem 8 : Non-compartmental analysis (NCA) of the kinetics of drug disposition. Physiological interpretation of the results

Exercise 9

- Study problem 9 : Building a user model in WinNonlin ; construction and validation of a non-linear calibration curve (logistic model) for analytical purposes

- A review : Appropriate calibration curve fitting in ligand binding assays by Findlay and Dillard

Exercise 10-11

- Study problem 10 & 11 : One-compartmental model ; Simultaneous IV and oral dosing for a new antibiotic in pigs

- Exercise 10 & 11 : Excel data sheet
- Excel sheet to compute a time above MIC

Exercise 12

- Study problem 12 : Bicompartmental model Kinetic disposition of a parent drug and its primary metabolite Physiological interpretation of results

- Exercise 12 : Excel data sheet

Exercise 13

- Study problem 13 : Deconvolution analysis vs. modelling to document the process of drug absorption

- Exercise 13 : Excel data sheet

Exercise 14

- Study problem 14 : Dose titration and selection of a therapeutic dose for a new quinolone in pigs

- Exercise 14 :Excel data sheet

Exercise 15

- Study problem 15 : Drug binding and investigation of the Michaelis Menten equation ; the pitfalls of the methods of linearisation

- Exercise 15 : Excel data sheet


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