| 简介/内容概述： | The scope of the guideline is limited to pharmacokinetic interactions, with a focus on metabolic enzyme- and transporter-mediated interactions. These aspects in general apply to the development of small chemical molecules. DDI evaluation of biologics is covered briefly, with focus on monoclonal antibodies and antibody-drug conjugates. Recommendations are provided on how to investigate interactions mediated by inhibition or induction of enzymes or transporters, both in vitro and in vivo (the terms ‘clinical’ and ‘in vivo’ are used interchangeably in this document), and on how to translate the results to appropriate treatment recommendations. The guideline also includes recommendations on how to address metabolite-mediated interactions. The use of model based data evaluations and DDI predictions are also covered. |
