Administration of drugs by nebulizer device [Design Issues]
Is possible to performing a bioequivalence study with a product that the administration is made by a device misting (nebulizer)? How to proceed with to drug ( minim systemic bioavailability) that escapes laterally from the front mask?
e.g.: beclomethasone suspension for nebulization 400 mcg / ml (ref.: Clenil A)
I understand that the bioequivalence study with nasal spray presentation (ref.: Clenil Nasal Spray) is possible! Because the loss from device is minim. On the other hand, the loss of drug from nebulizer device is very high!
Anybody to have an opnion about it?
Regards!
e.g.: beclomethasone suspension for nebulization 400 mcg / ml (ref.: Clenil A)
I understand that the bioequivalence study with nasal spray presentation (ref.: Clenil Nasal Spray) is possible! Because the loss from device is minim. On the other hand, the loss of drug from nebulizer device is very high!
Anybody to have an opnion about it?
Regards!
Complete thread:
- Administration of drugs by nebulizer deviceMauricio Sampaio 2014-10-16 23:41 [Design Issues]
- Administration of drugs by nebulizer device ElMaestro 2014-10-17 15:22