Ansøgeren oplyste, at der ikke var udarbejdet nogen protokol forud for in vitro- sammenligningen, men at man anvendte interne dokumenter med forudfastsatte kriterier, og at testproduktbatcherne blev underlagt frigivelses - og stabilitetstestning i henhold til protokoller fra kvalitetskontrolafdelingen.
The Applicant stated that no protocol was established before the in vitro comparison but that in house documents with pre-specified criteria were used and that test product batches were subjected to release and stability testing according to protocols from the quality control department.