Pharmacokinetic data for complex mixtures, where 'constituents with known therapeutic activity' are not established, should not be required (Fig. 1.6). Requirements for pharmacokinetic data should always relate to the Public Health and safety risks associated with the product. When there are safety concerns (e.g. photosensitization in the case of Hypericum perforatum) pharmacokinetic data are useful to provide safety margins. If there is a constituent with known therapeutic activity and a narrow therapeutic range, pharmacokinetic data will be required.

The same principles as defined for pharmacokinetic data shall apply for bioavailability/bioequivalence data. Need to provide bioavailability data for galenic preparations with modified release in view of the difficulty to use bibliographical data in such case (Source: European Medicines Evaluation Agency, London, 2001).

Bioavailability/Bioequivalence Problems/Question Bearberry extract (Arctostaphylos uva-ursl, folium) active constituents: Arbutin, indication: cystitis

30 25 20 15

Source: Keller (2001).

Color image of this figure appears in the color plate section at the end of the book.

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