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Jasim Uddin ☆ Bangladesh, 2012-10-22 09:16 (4998 d 23:47 ago) Posting: # 9438 Views: 3,961 |
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Dear Sir Can you please inform me whether Meter Dose Inhalation Aerosol requre BE? One of Arabic country is asking whether our Inhaler are bioequivalent. Sincerely. Jasim U. |
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ElMaestro ★★★ Denmark, 2012-10-22 13:11 (4998 d 19:51 ago) @ Jasim Uddin Posting: # 9439 Views: 3,329 |
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Hello Jasim Uddin, ❝ 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).
— Pass or fail! ElMaestro |
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Jasim Uddin ☆ Bangladesh, 2012-10-22 13:25 (4998 d 19:38 ago) @ ElMaestro Posting: # 9440 Views: 3,420 |
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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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ElMaestro ★★★ Denmark, 2012-10-22 13:30 (4998 d 19:32 ago) @ Jasim Uddin Posting: # 9441 Views: 3,490 |
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Hello Jasim. ❝ 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. A pMDI does not fall in this category since the active substance is not in gas form - it is just aerosolised. FDA is developing guidance in this field and they are quite strict. Read here for more information about the highly regulated markets. ❝ Should Chewable or Dispersible tablet require BE? Please share with me if you know about it. Hehe, for the regulated markets, yes, quite often a BE study is needed. I am not ruling out that it works differently in other markets or that you can argue BCS class I and get biowaivers etc. — Pass or fail! ElMaestro |
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jag009 ★★★ NJ, 2012-10-23 01:27 (4998 d 07:36 ago) @ Jasim Uddin Posting: # 9445 Views: 3,303 |
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Hi Jasim, ❝ Should Chewable or Dispersible tablet require BE? Please share with me if you know about it. If you mean rapidly disintegrating or flashdose tablets (put tablet on tongue and quickly break apart) then yes BE is required. John |
Ing. Helmut Schütz