Bioequivalence and Bioavailability Forum

No matrix effect observed during method development and method validation but what if matrix effect observed during subject sample analysis. ISTD {labelled IS} response difference in subject sample and CC/QC sample is found more than 40 percent. Moreover CC/QC samples were interspersed with subject samples and entire batch was processed in single processing batch.

Do we need to conduct further analysis with proper investigation and what if matrix effect observed due to change in population matrix.

Does this data accepted by regulatory agencies.

Looking for members opinion.

Thanks.

---

Edit: Category changed; see also this post #1 [Ohlbe]