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ElMaestro ★★★ Denmark, 2011-10-07 18:37 (5380 d 15:23 ago) Posting: # 7442 Views: 4,804 |
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Dear all, another wacky post from me: In this document from FDA (Ther. equivalent drugs 2011) FDA write "The primary concern from the regulatory point of view is the protection of the patient against approval of products that are not bioequivalent." Strictly speaking, do you agree this is or shold be the entire truth? I am inclined to say that it is equally important and in the interest of the wider public that FDA do not reject products that are truly bioequivalent. Do you agree? Anyone out there starting think two steps ahead will of course start wonder here: if yes, then how could the regulators actually regulate for that? If a company does not have good data how can FDA safegaurd against rejection if the products nevertheless are equivalent? This is of course an important point especially since the burden of proof is traditionally on the applicant, but this is not the point I primarily wish to raise or discuss. That aspect only becomes practically important for later discussion if the answer to the philosophystic question above is "yes". Lemme hear your thoughts, please. EM |
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Helmut ★★★   Vienna, Austria, 2011-10-07 20:12 (5380 d 13:49 ago) @ ElMaestro Posting: # 7443 Views: 4,263 |
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¡Olé! Lemme fire back with an oldie:*) The primary concern in bioequivalence assessment is to limit the risk of erroneously accepting bioequivalence. Only statistical procedures which do not exceed the nominal risk of 5% can be approved, and among them the one with the smallest risk of erroneously rejecting bioequivalence should be selected. Of course these were the ‘good old days’ when relying on unprovable assumptions was not mandatory. I evaluated ~300 BE studies solely by nonparametric methods (oh yes, the entire stuff: AUC, Cmax!) which would not ‘make it’ nowadays. Shall I feel guilty? *) CPMP Working Party Investigation of Bioavailability and Bioequivalence: Note for Guidance Section 3.6 Data analysis Document Ref. III/54/89-EN (1 May 1992) — 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, 2011-10-07 20:18 (5380 d 13:43 ago) @ ElMaestro Posting: # 7444 Views: 4,159 |
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Ahoy, ❝ I am inclined to say that it is equally important and in the interest of the wider public that FDA do not reject products that are truly bioequivalent. Do you agree? Well, not totally, if you put yourself in the regulator's position. If Company A develops a truly bioequivalent generic but fails to submit "good" (in FDA's opinion) data, why would FDA care ? Companies B, C, D and E will also develop their own generic. Patients will have access to the treatment anyway. The only case where this could be of concern is where the drug or technology is so special that only one company will try (and succeed) to develop a generic product. On a public health point of view, the patient will always have the option to get the originator. Of course the cost will not be the same, and the patient may not be able to afford it. But this becomes a political issue, not FDA's problem. Regards Ohlbe — Regards Ohlbe |
Ing. Helmut Schütz