Responsibles: W. Dewé, Collaborateur Scientifique, ULg - B. Boulanger, Chargé de cours adjoint, ULg

Objectives:

In introduction, the different types of ligand-binding assays are presented but the validation of definite and relative quantitative assays only is discussed in this training. The regulatory requirements are discussed and different designs of validation experiments are presented.
Most of the ligand-binding assays being based on a non-linear regression model, the basics of the non-linear curve fitting are reminded.
Validation criteria are then treated by presenting the methodology and different statistical approaches which can be used for their determination. In particular, measurement error based approaches like the Accuracy Profile and the Risk Profile are detailed.
Finally, several examples are studied for illustrate purpose.

 

Target audience:

This training is dedicated to the scientists who validate definite and relative quantitative ligand-binding assays. These assays are frequently used to assess the efficacy of a compound of interest in drug discovery as well as to quantify a biomarker either during the pre-clinical development (animal matrix) or during the clinical development (human matrix).

 

Program:

1. Introduction

• Method classification
• Objectives of an analytical method and its validation
• Regulatory documents (ICH, ISO, FDA, …)
• Design of experiment

2. Curve fitting and quantification

• Non-linear regression
• Inverse prediction

3. Validation criteria

• Linearity, trueness, precision, measurement error (β-expectation tolerance interval and risk assessment), limit of quantification, limit of detection

4. Examples

 

 

These trainings can be dispatched internally or in your company.

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