This document should be completed by the applicant to ensure the inclusion of all necessary Bioequivalence Trial information.
Residues Overall Summary (ROS) should be completed for pharmaceutical products intended for food producing species.
The formulation and API characteristics, including the route of administration and species, are factors which may affect requirements to waive bioequivalence studies (i.e., to compare the rate and extent of absorption between two formulations containing same active substances). Applicants must submit the following relevant information...
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This document has been archived.
This document has been archived.
This document has been archived.