The pharmaceutical industry would like the International Council for Harmonization (ICH) to clarify dosing information for rifampin and requests additional information on the use of biomarkers as a type of drug-drug interaction study (DDI), while the Pharmaceutical Research and Manufacturers of America (PhRMA) and Pfizer want more flexibility in developing a DDI strategy.
The comments were made in response to the US Food and Drug Administration’s (FDA) call for feedback on the ICH M12 guidance on DDI studies. The European Medicines Agency (EMA) released the guidance for comment in July (RELATED: EMA consults on ICH M12 guideline for drug-drug interactions studies, Regulatory Focus, 25 July 2022).
The guidance recommends designing, conducting and interpreting DDI studies mediated by enzymes and/or transporters that occur in vitro during the development of an investigational therapeutic drug…
