Does Inhalation Aerosol require BE? [Regulatives / Guidelines]

posted by Jasim Uddin – Bangladesh, 2012-10-22 13:25 (4995 d 17:39 ago) – Posting: # 9440
Views: 3,404

Thanks ElMaestro for your nice reply.

According to FDA regulations, the product "administered by inhalation as a gas, e.g., a medicinal or an inhalation anesthetic" does not require BE study.

Should Chewable or Dispersible tablet require BE? Please share with me if you know about it.

Best regards,

Jasim


Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

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