In all cases, characterization of PD and pharmacology using in vivo and/or in vitro models as noted in Table 3 and Section 2 is important and should be used in support of human dose selection.〔【出典】ICHガイドライン 〕
In addition, primary PD studies (in vivo and/or in vitro) are intended to investigate the mode of action and/or effects of a substance in relation to its desired therapeutic target.〔【出典】ICHガイドライン 〕
Then, if appropriate, an experimental evaluation (nonclinical, in vitro or in vivo, or clinical) of phototoxic potential should be undertaken before exposure of large numbers of subjects (Phase III).〔【出典】ICHガイドライン 〕
In vitro metabolic and plasma protein binding data for animals and humans and systemic exposure data (ICH S3A, Ref. 7) in the species used for repeated-dose toxicity studies generally should be evaluated before initiating human clinical trials.〔【出典】ICHガイドライン 〕
The limit for in vitro cell age for production should be based on data derived from production cells expanded under pilot plant scale or full scale conditions to the proposed in vitro cell age or beyond.〔【出典】ICHガイドライン 〕
Although not discussed in this guidance, consideration should be given to use of new in vitro alternative methods for safety evaluation.〔【出典】ICHガイドライン 〕
Further information on pharmacokinetics (PK) (e.g., absorption, distribution, metabolism and excretion), in test species and in vitro biochemical information relevant to potential drug interactions should be available before exposing large numbers of human subjects or treating for long duration (generally before Phase III).〔【出典】ICHガイドライン 〕