English Abstract 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