As this rendered their analytical accuracy unclear we excluded them from subsequent proof-of-safety analysis.
The result from the proof-of-safety analysis depends on the definition of acceptable deviation.
Defining acceptable deviation as being within the symmetric boundary decided by the traditional cultivar furthest away from the control line, we performed a proof-of-safety analysis for the metabolite levels of the transgenic lines.
The first step in our SE evaluation was proof
Rejection of the proof-of-safety null-hypothesis may then be interpreted as an indication of acceptable metabolite levels.
No clinical testing or proof of safety is generally needed.
Even then, manufacturers could be given 30 months longer to submit proof of safety and effectiveness, an F.D.A. official said.
But today two members of a NISA advisory committee called the stress tests flawed and "not proof of safety".
This is not possible for the data used as a proof of safety for commercial authorizations.
The proof of safety, then, doesn't happen with lab experiments on guinea pigs.
