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kudra23 ☆ 2012-01-30 11:30 (5246 d 05:48 ago) Posting: # 8016 Views: 3,019 |
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Dear all, There are two products (x mg and y mg capsules) for which BE study will be conducted. We want to submit one of the dosage forms as a biowaver. Although the other criteria is all fulfilled as per the general biowaver criteria defined in the 4.1.6th article of the guideline, linearity of the active is not known. Can you please advise how to proceed? |
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Helmut ★★★   Vienna, Austria, 2012-01-31 03:45 (5245 d 13:33 ago) @ kudra23 Posting: # 8019 Views: 2,691 |
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Dear Kudra! ❝ Although the other criteria is all fulfilled as per the general biowaver criteria defined in the 4.1.6th article of the guideline, linearity of the active is not known. You found the answer already yourself (in bold above). Linear PK is a requirement. — 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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Ohlbe ★★★ France, 2012-01-31 18:47 (5244 d 22:31 ago) @ Helmut Posting: # 8028 Views: 2,422 |
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Dear Helmut and Kudra, ❝ Linear PK is a requirement. Actually a waiver can also be obtained in case of non-linear PK, if you conduct your study at the strength expected to be the most sensitive to detect differences between products. But for this you need to know whether the increase in PK parameter values is less than proportional or more than proportional to the dose... Regards Ohlbe — Regards Ohlbe |
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kudra23 ☆ 2012-01-31 19:18 (5244 d 22:00 ago) @ Ohlbe Posting: # 8032 Views: 2,436 |
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Dear Helmut thanks for your prompt reply however, i exactly wanted to confirm what Ohlbe indicated. There are exceptions for non-linearity cases as per the new BE guideline (CPMP/QWP/EWP/1401/98 Rev. 1/Corr). In the previous version, non-linearity used to lead us to conduct BE study for all strengths. Thank you both of you for your kind help. Regards, Edit: unneeded quotation marks deleted [Ohlbe] |
Ing. Helmut Schütz