The sponsor is responsible for ensuring that the investigational pharmaceutical product(s) and, if applicable, comparator products supplied for the clinical trial are of appropriate quality and subject to quality assurance procedures (see Section 5.11).

If significant changes are made in the formulation of the investigational or comparator product during the course of the trial, the results of additional studies (e.g. on the stability, comparative dissolution rate or, as appropriate, comparative bioavailability) should be made available before the new formulation is used in the trial. The studies would demonstrate that the changes would not be expected to alter the pharmacokinetic profile or other clinical characteristics of the product.