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Paresh ☆ 2011-08-05 10:52 (5433 d 07:31 ago) Posting: # 7261 Views: 6,383 |
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Dear all, Drug having comparable dissolution data as reference drug. Although drug fail to achieve bioequivalence criteria. Can you provide reason for the same? Thanks in advance Edit: Category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2011-08-05 12:28 (5433 d 05:56 ago) @ Paresh Posting: # 7263 Views: 5,181 |
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Dear Paresh! ❝ Drug having comparable dissolution data as reference drug. Don’t mix up ‘drug’ with ‘drug product’ or ‘formulation’. I guess you compared a ‘test product’ with the ‘reference product’. ❝ Although drug fail to achieve bioequivalence criteria. ❝ ❝ Can you provide reason for the same?
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Paresh ☆ 2011-08-05 16:15 (5433 d 02:08 ago) @ Helmut Posting: # 7268 Views: 5,165 |
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Thanks for promt reply. But in pivotal study reference drug also behave lower side as compare to pilot study. Dissolution we check the rate of drug dissolve/release from formulation to solution. If drug having limited permeability then both test and reference drug affect not only single one. 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! Added last paragraph from another post. Don’t start a new post if you want to add something; edit your original post instead. [Helmut] |
Ing. Helmut Schütz