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Version 1.2 December 2019
15.9 Justification for not submitting biopharmaceutic data
If biopharmaceutic data would normally be required but was not generated:
- Include a justification for not submitting the data included in Module 1.9.2 of the CTD.
In preparing a justification:
Address at least the following issues, as applicable:
- the nature of the dosage form
- the solubility of the drug substance(s)
- the similarities of, or differences between, the formulations being considered
- the comparative dissolution profiles across the physiological pH range (1-7.5) of the products being considered
- the pharmacokinetic characteristics of the drug substance(s), such as permeability (or absolute bioavailability), linearity, first-pass effect (if any) and its significance
- the clinical consequences of any potential differences in bioavailabilities of the products under consideration (e.g. increased dose leading to toxicity or decreased dose leading to lack of efficacy)
- the margin between the minimum effective and minimum toxic plasma concentration.
Provide copies of any cited literature.
Use, where relevant, the Biopharmaceutic Classification System (BCS) to justify not undertaking in vivo bioequivalence studies.
The optional Biowaiver templates (BCS-based or additional strength) may replace the requirement to complete Module 2.5 of the CTD and some other requirements.
To find out if you can use these templates, see guidance on Completing the Biowaiver templates.
We do not have a list of drug substances that are considered to fall within particular BCS classes.