Bioequivalence and Bioavailability Forum

Dear Rajendra!

❝ Please provide Batch Sequence for study sample analysis as per ANVISA.

For ANVISA's documents see the Guidance page.
Re 899 (May 2003) states:
4.2. An analytical run must contain: QC samples, calibration standards and unknown samples of one or more subjects of the study. It is preferable that all the samples of a same subject be analyzed in a single run.
4.5. The QC samples must be incorporated at appropriate intervals, depending on the total number of samples in the run, always in the same number of the replicates of each concentration (QCL, QCM and QCH).
4.6. The number of QC samples (in multiples of three) to be incorporated in each analytical run must not be lower than 5% (five percent) of the number of unknown samples. For analytical runs consisting of up to 120 samples, at least 6 (six) QCs (a duplicate of each concentration) must be present.