Gommer AM2012-12-122012-12-121991-11-30http://hdl.handle.net/10029/260180Abstract niet beschikbaarThe 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.97 pen1991-4alternatiefidentiteiteuropese farmacopeepyrogeenendotoxine; abnormale toxiciteitcalcitoninecorticotropinegonadotropine; humaan groeihormooninsulineoxytocinealternativeidentity; european pharmacopoeiapyrogenbacterial endotoxinabnormal toxicity; depressor substancescalcitonincorticotrophinglucagon; gonadotrophinhuman growth hormoneinsulinoxytocintetracosactide; high performance liquid chromatographyin vitroReport2012-12-12