Does Inhalation Aerosol require BE? [Regulatives / Guidelines]
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]
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]
Complete thread:
- Does Inhalation Aerosol require BE? Jasim Uddin 2012-10-22 07:16
- 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
