The International Council for Harmonization (ICH) issued a public consultation of the M12 guideline entitled “DRUG INTERACTION STUDIES”. Medical Affairs professionals are familiar with the critical dilemma they may face when in the development of a NCE in which they must consider the implementation of interaction studies. This is an ongoing focus, as the development of any new drug following the approval of any NCE may create the need for additional interaction studies.
The guideline recommends maintaining a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical pharmacokinetic drug-drug interaction (DDI) studies during the development of a therapeutic product. These aspects in general apply to the development of small chemical molecules. DDI evaluation of biologics is only covered briefly, with focus on monoclonal antibodies and antibody-drug conjugates. Guidance is provided on how to investigate interactions mediated by inhibition or induction of enzymes or transporters, both in vitro and in vivo, 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 evaluation and DDI predictions are also covered.
All professionals in Pharmaceutical Medicine interested in this challenging topic, are invited to offer comments and suggestions to the guideline. The deadline for contribution is November 21, 2022.
Read the draft guideline here.
Disclaimers
- The material in these reviews is from various public open access sources, meant for educational and informational purposes only
- Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
- No official support by any organization(s) has been provided or should be inferred
