Regulatory Open Forum

Hello,

I have a thermal cycling study (for a generic) and I would like some thoughts/help where I should place it in the eCTD.  What module would be the appropriate module to include the thermal cycling study data?

Thanks in advance,

Hi Olga,

According to the ANDA Content and Format guidance, the thermal cycling study would go in P.8.3 Stability.  If you discuss it in your development report, you would also discuss it in P.2, and reference between the 2 sections.  I would put the data in the Stability section.

Thank you!