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Summary of a bioavailability or bioequivalence study
This form should be used by prescription medicine, over-the-counter and registered complementary medicines sponsors to submit a summary of a bioavailability or bioequivalence study.
How to access a pdf or Word document
- Summary of a bioavailability or bioequivalence study (pdf,367kb)
- Summary of a bioavailability or bioequivalence study (docx,137kb)
An alternative Bioequivalence Study Information Form is available to summarise each bioequivalence study. For more information, see Bioequivalence data summary templates below.
Bioequivalence data summary templates
The optional bioequivalence data summary templates are designed to help you prepare a submission for a new generic prescription medicine and ensure all the necessary information is provided at the time of application.
The templates are equivalent to similar templates used by comparable overseas regulators and our international collaborators in international regulatory forums.
Bioequivalence study summary template
This form could be used when you are submitting bioequivalence study data.
- Bioequivalence Study Information Form (BSIF) (pdf,227kb)
- Bioequivalence Study Information Form (BSIF) (docx,180kb)
For guidance on completing this template, see Completing the Bioequivalence Study Information Form.
Biowaiver templates
Additional strength biowaiver template
This template could be used when bioequivalence study data has not been generated for all strength products and you are required to submit biowaiver data for these products.
- Additional strengths biowaiver template (pdf,184kb)
- Additional strengths biowaiver template (docx,149kb)
Note: the additional strength biowaiver template currently is designed for systemically active immediate release oral dosage form.
Biopharmaceutics Classification System (BCS)-based biowaiver template
This template could be used when you are submitting BCS-based biowaiver data for all proposed strength products.
- Biopharmaceutics Classification System (BCS)-based biowaiver template (pdf,242kb)
- Biopharmaceutics Classification System (BCS)-based biowaiver template (docx,169kb)
For guidance on completing the biowaiver templates, see Completing the biowaiver templates.
If you submit the BSIF, BCS-based biowaiver template, or an equivalent overseas template, you will not be required to submit:
- Module 2.5
- Module 2.7
- Summary of a bioavailability or bioequivalence study form.
For further details, refer to guidance on Completing the Bioequivalence Study Information Form and Completing the biowaiver templates.
If you have any enquiry about templates, direct your queries to pcsinbox@health.gov.au.