The guidelines for the testing of medicines is harmful in pregnancy, the world changed. In practice, this means that there are now hundreds of thousands of animals each year, less and less can be used.
This is the first time in 25 years that the guidelines be changed, says the board, for the Evaluation of Medicinal products (CBG) on Monday.
Before a new drug is on the people being investigated may be, there is a need for data on possible toxicity. Traditionally, there are animal studies to be used.
In accordance with the modified directive and in certain animal experiments, it is only now, at a later stage in the research programme need be. Because many new drugs are in earlier stages of testing, to lose weight, you need fewer animals to be used for the new medication to try out.
The other big change is the replacement of animal experiments by the so-called in vitro tests. These are tests in which research is carried out by, for example, cultured cells are used. For the compounds of medicijngroepen that are known to be harmful if you are pregnant, may become an in vitro assay will be sufficient.
Laboratory animal research must comply with the so-called ICH-guidelines. Registration authorities, and the pharmaceutical industry this week on an international level, guidelines for the medicijnonderzoek to vote. That’s the plan for the new rules to be presented to you.
So, what to expect from the apenlab in Rijswijk, the netherlands
- Each and every morning to know what is at night you have missed it? Around midday an update on the most important piece of news? Subscribe to our daily newsletter.