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Mahesh M ★ India, 2013-12-26 08:53 (4564 d 11:18 ago) Posting: # 12109 Views: 2,386 |
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Dear all, Can we demonstrate BE study on recommended dose strength if there is no safety issue? Eg: Reference drug are available in two strength 180 mg and 360 mg. Its recommended dose is 720 mg in SPC. Then at what dose one should assess BE for such drug? single tablet (360 mg dose) or 2 tablets (360 X2 = 720mg dose). (There is no safety issue and analytical issue, PK can be well characterized with single dose also.) kindly suggest Regards Mahesh |
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Helmut ★★★   Vienna, Austria, 2013-12-26 14:55 (4564 d 05:17 ago) @ Mahesh M Posting: # 12111 Views: 1,900 |
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Dear Mahesh, ❝ Can we demonstrate BE study on recommended dose strength if there is no safety issue? […] PK can be well characterized with single dose also. Why do you want to do that, since you have no problems with analytical sensitivity? ❝ Reference drug are available in two strength 180 mg and 360 mg. Which regulation are you aiming at? In the US, generally one strength is the RLD. If there are two, either formulations greatly differ by their galenic principle or the labeled use (different indications). So you are not “free” in picking one of them. Given linear PK for the EEA it’s the highest strength, not the highest approved dose – in the case of non-linear PK the lowest and highest strengths. ❝ Its recommended dose is 720 mg in SPC. Highest single or daily dose? If you would have sensitivity issues, only if the former is stated in the SPC you could go ahead. Since you used the European term “SPC”, 360 mg is the way to go (see the BE GL, Section 4.1.6). — 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 |
Ing. Helmut Schütz