The conference report about EUFEPS open forum on ICH M13A is now available!
During the meeting the most relevant aspects of the ICH M13A draft have been discussed in order to scientifically contribute to the decision process of guideline finalisation. Major aspects have been the choice of study population (females and/or males), request for fasted and/or fed studies, consequences of differences in drug product content, handling of aberrant plasma profiles and additional requirements in case of pH-dependant solubility.
We are happy that Ralph-Steven Wedemeyer, our expert on biopharmaceutics, contributed to the program, the conference as well as to the report as one of the co-authors.
You can find the publication here: ICH M13A Conference Report