Comprehensive summary: Bioequivalence - Veterinary drugs

The Comprehensive Summary-Bioequivalence (CS-BE) is intended to assist sponsors in summarizing information regarding the conduct and analysis of pivotal comparative bioavailability (including bioequivalence) studies to support a veterinary generic drug regulatory submission.

The template is not mandatory for an Abbreviated New Drug Submission (ANDS); however, it is a tool intended to support veterinary drug sponsors by providing a standardized approach for submitting bioequivalence study results to Health Canada. If a section or field does not apply, this should be indicated by "Not applicable" or "N/A" in the appropriate area, with an accompanying explanatory note.

To obtain a copy or if you have questions about the template, email us directly at vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca

The key input fields of the template include:

• Summary of product information
• Administrative summary
• Product composition/formulation
• Reference product overview
• Identification of drug characteristics and dosage form properties
• Biopharmaceutic studies (comparative bioavailability/bioequivalence)
• Study subjects
• Protocol deviations
• Safety evaluation
• Efficacy evaluation
• Analytical study report
• Analytical validation report