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dixit ★ India, 2011-06-06 09:29 (5503 d 21:46 ago) Posting: # 7070 Views: 6,350 |
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Dear All, Many of the regulatory bodies specify that the potency between the test and reference products should not differ more than 5%. Can any one please let me know what would be the impact in a bio equivalence study if the difference is more. Regards, DIXIT. |
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Helmut ★★★   Vienna, Austria, 2011-06-06 16:54 (5503 d 14:20 ago) @ dixit Posting: # 7078 Views: 5,645 |
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Dear Dixit, the subject lines tells it all. I don’t want to go through all different regulations, but will be happy doing so if you give us more information. — 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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dixit ★ India, 2011-06-07 09:02 (5502 d 22:12 ago) @ Helmut Posting: # 7083 Views: 5,615 |
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Dear Helmut, Here is the reference. The assayed content of the batch used as test product should not differ more than 5% from that of the batch used as reference product determined with the test procedure proposed for routine quality testing of the test product. Regards, DIXIT. Edit: Subject line changed, reference linked; see here. [Helmut] |
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Helmut ★★★ Vienna, Austria, 2011-06-07 14:59 (5502 d 16:15 ago) @ dixit Posting: # 7090 Views: 5,778 |
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Dear Dixit! You dropped and essential part in quoting Section 4.1.2: Unless otherwise justified, the assayed content of the batch used as test product should not differ more than 5% from that of the batch used as reference product determined with the test procedure proposed for routine quality testing of the test product. The Applicant should document how a representative batch of the reference product with regards to dissolution and assay content has been selected. For an acceptable justification see the GL Section 4.1.8:In bioequivalence studies, the pharmacokinetic parameters should in general not be adjusted for differences in assayed content of the test and reference batch. However, in exceptional cases where a reference batch with an assay content differing less than 5% from test product cannot be found (see section 4.1.2) content correction could be accepted. If content correction is to be used, this should be pre-specified in the protocol and justified by inclusion of the results from the assay of the test and reference products in the protocol. (my emphases)— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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raghu ★ India, 2011-06-07 12:47 (5502 d 18:27 ago) @ dixit Posting: # 7087 Views: 5,612 |
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Dear Dixit, The assayed content should not differ more than 5% b/w test and reference batch. If it is present, the BE study should not be performed. The regulatory authorities will not accept BE study with the difference of 5% b/w test and reference batch. Regards Raghavender. |
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Helmut ★★★ Vienna, Austria, 2011-06-07 15:26 (5502 d 15:48 ago) @ raghu Posting: # 7093 Views: 5,630 |
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Dear Raghavender! ❝ The assayed content should not differ more than 5% b/w test and reference batch. ❝ ❝ If it is present, the BE study should not be performed. False in many countries. See above for the EMA. According to current Canadian guidances two evaluations have to be performed: one on raw data and another one corrected for measured content. The correction was dropped in 2010’s draft, but Appendix 1 Number of Subjects states: Choose an expected true ratio of test over reference means (usually 100%, but consider potency differences between the test and reference products). (my emphasis; tables give expected T/R-ratios up to -15% and +20%)You are right with the ![[image]](img/uploaded/IAsmall.png) FDA (2003):The drug content of the test product cannot differ from that of the reference listed product by more than 5 percent. ❝ The regulatory authorities will not accept BE study with the difference of 5% b/w test and reference batch. See above. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz