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RegisterDoes Inhalation Aerosol require BE? [Regulatives / Guidelines]
Hello Jasim Uddin,
It differs a lot from country to country. The most highly regulated markets have some pretty restrictive rules re. BE* for inhalers, and some agencies seem to accept almost anything. Further some countries accept BE* argumentation on basis of in vitro data for pMDIs. Such in vitro data could be generated via cascade impactor particle size profiles (and profile comparisons).
❝ Can you please inform me whether Meter Dose Inhalation Aerosol requre BE? One of Arabic country is asking whether our Inhaler are bioequivalent.
It differs a lot from country to country. The most highly regulated markets have some pretty restrictive rules re. BE* for inhalers, and some agencies seem to accept almost anything. Further some countries accept BE* argumentation on basis of in vitro data for pMDIs. Such in vitro data could be generated via cascade impactor particle size profiles (and profile comparisons).
- some countries prefer the term "Therapeutic equivalence" over BE, due to legal definitions, but that might just be a technicality.
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Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Does Inhalation Aerosol require BE? Jasim Uddin 2012-10-22 07:16
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Does Inhalation Aerosol require BE?ElMaestro 2012-10-22 11:11
- Does Inhalation Aerosol require BE? Jasim Uddin 2012-10-22 11:25
- Does Inhalation Aerosol require BE? ElMaestro 2012-10-22 11:30
- Does Inhalation Aerosol require BE? jag009 2012-10-22 23:27
- Does Inhalation Aerosol require BE? Jasim Uddin 2012-10-22 11:25
- Does Inhalation Aerosol require BE?ElMaestro 2012-10-22 11:11
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