Synaptogenix Inc (SNPX)

[Whatsupp]

You are wrong - This is from the FDA Industry guidance document for bio-equivalence.

"IV. ESTABLISHING BIOEQUIVALENCE FOR DIFFERENT DOSAGE FORMS
The following sections provide recommendations for establishing BE for specific dosage forms.
As explained below, in certain cases BE testing may be waived.
A. Oral Solutions
For oral solutions, elixirs, syrups, tinctures, or other solubilized forms, an in vivo BE testing
requirement may be waived for certain products on the ground that in vivo BE is self-evident. In
such instances, the applicant would be deemed to have complied with and fulfilled any
requirement for in vivo BE data.16 For example, BE can be waived for an oral solution if the
formulation has the same active ingredient in the same concentration and dosage form as the
RLD, and does not contain any excipient that significantly affects drug absorption or
availability.17 "