RIVM Report 319001001
Abstract niet beschikbaar
The quality standards with which parmaceutical substances have to comply are provided by pharmacopoeias. Traditionally, experiments on animals are required for the assessment of the biological activity of certain pharmaceutical substances, particularly those of natural origin. Furthermore, animal tests are used to ensure the purity and safety of pharmaceutical substances. This report provides an inventory of the state of affairs in refining and/or replacing animal tests traditionally required and applied for the estimation of potency of hormones and hormonal products. Also the status quo of replacing some general safety tests are discussed. It is concluded that over the past few years a clear tendency towards the replacement of traditional in vivo bioassays could be observed. However, the actual introduction of alternatives is only slowly taking place, mainly for lack of information about the validity of such techniques. The report includes suggestions and recommendations with regard to the development, validation and application of alternative methods.