Global assessment of usefulness integrates components of both benefit and risk and reflects the decision making process of the treating physician, who must weigh benefit and risk in making product use decisions.〔【出典】ICHガイドライン 〕
If global usefulness is specified as primary, it is important to consider specific efficacy and safety outcomes separately as additional primary variables.〔【出典】ICHガイドライン 〕
A problem with global usefulness variables is that their use could in some cases lead to the result of two products being declared equivalent despite having very different profiles of beneficial and adverse effects.〔【出典】ICHガイドライン 〕
(6) Pharmaceutical excipients are substances other than active substances contained in preparations, and they are used to increase the utility of the active substance(s) and preparation, to make formulation process easier, to keep the product quality, to improve the usability, and so forth.〔【出典】第十六改正日本薬局方(平成23年3月24日 厚生労働省告示第65号)〕