20 Sep Veterinary Medicines Biowaiver Application Form for Parenterals
Posted at 17:50h
in
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 in support of a biowaiver for parenterals.
2022 Sept
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Document Number:
OF-PEM-VET-04B
Version:
1
Date Updated:
07/09/2022
File Type:
docx
Category:
Form