2022 ICH M12 Draft Guideline for Drug Interaction Studies
“In clinical practice, patients are often prescribed more than one drug which can result in a DDI (drug-drug interaction). Some patients, in particular fragile older patients or patients with serious or multiple health issues, can be prescribed a large number of different drugs (i.e., polypharmacy). The occurrence of DDIs is a common clinical problem that can increase the risk of adverse events, sometimes leading to hospital admissions. Alternatively, some DDIs can reduce treatment efficacy. Hence, it is important to consider an investigational drug’s potential to interact with other drugs.
This Guideline provides general recommendations on how to evaluate the DDI potential of an investigational drug. It is recognized that the DDI evaluation is generally tailored based on the specific drug, intended patient population, and therapeutic context. Alternative approaches can be used if they satisfy the requirements of the applicable statutes and regulations. The focus of the Guideline is the development of new drugs, but if new scientific information regarding the potential for DDIs is obtained after drug approval, additional DDI evaluation should be considered.”