Zdrowie i gospodarka · 01/03/1995
International Conference on Harmonisation; Guideline on Repeated Dose Tissue Distribution Studies; Availability
The Food and Drug Administration (FDA) is publishing a final guideline entitled ``Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies.'' This guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline is intended to provide guidance on the circumstances when nonclinical repeated dose tissue distribution studies to support drug registration should be considered and on the conduct of those studies.