Modelling and in vitro test methods.
This recent event hosted by DHI attracted 35 participants from Denmark and Sweden, ranging from governmental bodies, industries and investors. Per Nedergaard, started out by giving an overview of the regulatory requirements, as stated in the EMEA and ICH guidelines. Lisbeth Knudsen presented the activities in ECVAM, and 3R strategy, (Reduce the number of animals used, Refine the tests for optimal use of the animals and Replace the number of animal test) a paradigm shift where QSAR and In vitro methods are expected to gradually replace animal testing. Karl-Heinz Cohr discussed the use of QSAR in relation to the different endpoints; Physico-chemical properties, Pharmaco- Toxicokinetic properties and Pharmaco- Toxicodynamic properties of a drug candidate. This was followed by Johan Areberg who discussed the use of PK/PD modelling in drug development, and Magrethe Winther-Nielsen who explained the newly implemented guidelines for environmental risk assessments of medicinal products. Tina Zinck completed the presentations by explaining the requirements for first-in-man clinical trials.
The titles of the presentations which are available under ‘Presentations’ are:
- Regulatory requirements; from idea to drug, Per Nedergaard, DHI
- Development of tests and procedures, Rasmus Nelund, Pipeline Biotech A/S
- In vitro methods, and ECVAM, Lisbeth Knudsen, Institute of Public Health University of Copenhagen
- QSAR, Karl-Heinz Cohr, DHI
- PK/PD modelling, Johan Areberg, Lundbeck
- The newly implemented EMEA requirements for Ecotox testing; Margrethe Winther-Nielsen, DHI
- Requirements for first-in-man clinical trials, Tina Zinck, Danish Medicines Agency