Ansøgeren oplyste, at de fremlagte in vitro- data kan være prædikative for farmakokinetisk bioækvivalens for Cmax og for maksimale luftvejsreaktioner og systemiske beta- 2 - adrenoreceptormedierede reaktioner, der hovedsageligt bestemmes af lungebiotilgængelighed.
The Applicant stated that the presented in vitro data can be predictive of pharmacokinetic bioequivalence for Cmax and for peak airway and systemic beta-2 adrenoceptor mediated responses, which are mainly determined by lung bioavailability.