Submitted by the Editor on behalf of a StabilityHub User
I’m exploring stability data reporting options in JMP, and wanted to baseline with any formatting requirements for data tables used in regulatory filings. Google hasn’t been helpful in locating guidances; are you aware of any (FDA, EMA)?
Obvious requirements are: time point, test, specification and result.
Are there requirements on how this is formatted? How footnotes appear? requirements for method or detection equipment (HPLC-UV), etc. If graphical representations are utilized (linear regression) are there any requirements (r2 must be reported, etc.)