Quality Assurance in Drug Development: Criteria for safety assessments
G. De Schrijver
Labcore, Belgium

The presentation explains how to make a rational approach when selecting and conducting safety pharmacology studies. It emphasizes on how the actual clinical laboratory will implement and use scientifically valid methods, preferable internationally recognized.
Achieve a reliable and accurate result within the actual economical constraints is the major challenge. The requirements of the applicable guidelines are discussed within this context and some practical application examples are given. Special attention is paid to the pre-analytical, analytical and post-analytical processes and how to control them. More details are given on the following basic processes:

- the analytical process from receipt of the sample to the provision of the result;
- the analytical procedure: from method validation to the regular (daily) performance of the analysis

The link with the requirements of international guidelines such as ISO 17025 and ISO 15189 is also documented together with the indication that the implementation of an integrated quality management system is the absolute condition to assure the best possible clinical valid result with a level of quality within the limitations of the actual technology.
A short overview of the different validation elements is explained together with the practical approach in the laboratories of the 21st century. To finish, the most common compliance issues are also discussed.