Regulacje i polityka gospodarcza · 09/11/1994

International Conference on Harmonisation; Dose-Response Information to Support Drug Registration; Guideline; Availability; Notice

The Food and Drug Administration (FDA) is publishing a final guideline entitled ``Dose-Response Information To Support Drug Registration.'' The guideline is applicable to both drugs and biological products. This guideline was prepared by the Efficacy Expert Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline describes why dose-response information is useful and how it should be obtained in the course of drug development. This information can help identify an appropriate starting dose as well as how to adjust dosage to the needs of a particular patient. It can also identify the maximum dosage beyond which any added benefits to the patient would be unlikely or would produce unacceptable side effects. This guideline is intended to help ensure that dose response information to support drug registration is generated according to sound scientific principles.