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Mauricio Sampaio ★ Brazil, 2014-10-17 01:41 (4269 d 19:16 ago) Posting: # 13737 Views: 4,765 |
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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! |
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ElMaestro ★★★ Denmark, 2014-10-17 17:22 (4269 d 03:35 ago) @ Mauricio Sampaio Posting: # 13743 Views: 3,763 |
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Hello Mauricio, ❝ 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? ❝ Anybody to have an opnion about it? BE is sometimes used to compare drugs for inhalation. See e.g. the EU guideline. By convention you study the amount of drug in the blood; what escapes at the nozzle/mouthpiece/mask area isn't really of much interest. Comparative PK is used for both safety and efficacy (the latter often together with charcoal to block GI absorption), and it is a matter that is subject to much debate. — Pass or fail! ElMaestro |
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