Workshop April 2011

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