As there is currently no comparator product available, a bioequivalence study is not possible. The primary pathway to approval of the safety and efficacy portion of a dossier for most products will be via a biowaiver application. A biowaiver from the requirement to conduct in vivo studies is possible if adequate supporting documentation is provided. The requirements for a biowaiver are described below.
- Tablets (dispersible)
- The absorption of zinc is sensitive to many factors that affect either gastrointestinal status or the availability of the zinc through interactions such as complexation.
For this reason, a waiver from the requirement to provide in vivo study data on the proposed product can be considered under specific circumstances as follows:
- evidence is provided to demonstrate that the excipients do not negatively impact the absorption of zinc
and - the zinc from the proposed product is proven to be completely in solution after one minute using the
solubility test.
