Bioanalytical Community

Hi,

I have a question about sample analysis report formatting, for a interim report is it necessary to follow the M10 guidance regarding what to include in a bioanalysis report? If not, what type of information is needed in the interim report?

Thank you so much!

I think it would depend on what the purpose for the report would be.  If it is to be included in a regulatory submission, it would at minimum be best to acknowledge what might be absent and that it will be included in the next interim or in the final bioanalytical sample analysis report.

Thomas Tarnowski, Ph.D.

Executive Director, Bioanalytical Chemistry

Gilead Sciences, Inc.

Hi,

I have a question about sample analysis report formatting, for a interim report is it necessary to follow the M10 guidance regarding what to include in a bioanalysis report? If not, what type of information is needed in the interim report?

Thank you so much!

Hello,

I have a related question. Is it expected to include sample results in a bioanalytical report (interim or final)? The data would already be reported in the clinical study report, so I would expect not to repeat it, however it is possible to interpret M10 as needing to include the data.

Thanks for any opinions either way.

I think it would depend on what the purpose for the report would be.  If it is to be included in a regulatory submission, it would at minimum be best to acknowledge what might be absent and that it will be included in the next interim or in the final bioanalytical sample analysis report.

Thomas Tarnowski, Ph.D.

Executive Director, Bioanalytical Chemistry

Gilead Sciences, Inc.

Hi,

I have a question about sample analysis report formatting, for a interim report is it necessary to follow the M10 guidance regarding what to include in a bioanalysis report? If not, what type of information is needed in the interim report?

Thank you so much!

Results are included in the bioanalytical report. To make it easier on my vendors, we ask them to insert a table that corresponds exactly to the data file submitted to data management. It provides traceability of all data from the laboratory through the subsequent analyses.

Hello,

I have a related question. Is it expected to include sample results in a bioanalytical report (interim or final)? The data would already be reported in the clinical study report, so I would expect not to repeat it, however it is possible to interpret M10 as needing to include the data.

Thanks for any opinions either way.

I think it would depend on what the purpose for the report would be.  If it is to be included in a regulatory submission, it would at minimum be best to acknowledge what might be absent and that it will be included in the next interim or in the final bioanalytical sample analysis report.

Thomas Tarnowski, Ph.D.

Executive Director, Bioanalytical Chemistry

Gilead Sciences, Inc.

Hi,

I have a question about sample analysis report formatting, for a interim report is it necessary to follow the M10 guidance regarding what to include in a bioanalysis report? If not, what type of information is needed in the interim report?

Thank you so much!