In some situation such a bioequivalence revise may be replace by in vitro disbanding testing after such a replacement is allowed by registration establishment this is referred to as a “biowaiver“. The assessment of a request by a pharmaceutical industryfor such a ‘bio waiver’ is an important aspect in the assessment carried out by the RIVM.

The value of in vitro closure testing as a substitute for bioequivalence testing is yet not clear. This project will provide such technical knowledge. Among European and North American registration establishment, experts from the RIVM rationally have a recognised position Biopharmaceutics in the field of bioequivalence assessment and it is in the interest of the RIVM to keep this position. This project intends to serve that idea.

This FDA outline describes only suitable events to get hold of the data on the permeability, solubility and termination to request for a ‘biowaiver’. The draft contain no list of active ingredient for which such a ‘biowaiver’ might be possible, nor describes the draft the suspension conditions to be met for each active material¬† for such a biowaiver. Setting up such a list of active ingredient and suspension criteria to be met for each active element is also a target of the WHO for their “important Drugs”.

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