Workshop April 2011


List of attendees
Evaluation form

Reviews on the main PK parameters

Plasma clearance
Volume of distribution
Plasma protein binding


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


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