#641881
I gcás inarb iomchuí, pléifear corrlaigh sábháilteachta i dtéarmaí nochta choibhneasta shistéamaigh don táirge íocshláinte imscrúdaitheach, bunaithe ar shonraí maidir leis an “réimse faoin gcuar” (RFC) más féidir, nó sonraí maidir le buaicthiúchan (Cmax), cibé ceann acu is ábhartha, seachas i dtéarmaí na dáileoige a thugtar.
Where appropriate, safety margins shall be discussed in terms of relative systemic exposure to the investigational medicinal product, preferably based on ‘area under the curve’ (AUC) data, or peak concentration (Cmax) data, whichever is considered more relevant, rather than in terms of applied dose.