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joyjac ★ Philippines, 2011-06-03 10:59 (5493 d 20:37 ago) Posting: # 7058 Views: 6,065 |
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Hi colleagues, For comparative dissolution profile and consequently, bioequivalence testing, can 2 tablets of the test drug be compared with 1 tablet of the reference drugs? The label claim of the test drug is 5 mg/tablet while the reference drug available locally has a strength of 10 mg. May I solicit your thoughts on this. Thanks. |
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Helmut ★★★   Vienna, Austria, 2011-06-03 17:13 (5493 d 14:23 ago) @ joyjac Posting: # 7063 Views: 4,894 |
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Dear Joy, nice to have you back!  ❝ For comparative dissolution profile and consequently, bioequivalence testing, can 2 tablets of the test drug be compared with 1 tablet of the reference drugs? The label claim of the test drug is 5 mg/tablet while the reference drug available locally has a strength of 10 mg. May I solicit your thoughts on this. Dissolution testing should be performed with one unit. Having two tablets in the vessel will change hydrodynamics. Why don’t you compare 1 unit of 5 mg with 1 unit of 10 mg in vitro? On the y-axis you have %dissolved – not absolute values anyhow. I once have seen an accepted (!) biowaiver where 2 units vs. 1 units were tested – but this was a mistake both by the applicant and the assessor.  In the biostudy: 2×5 mg (test) vs. 1×10 mg (reference). — 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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joyjac ★ Philippines, 2011-06-06 04:43 (5491 d 02:53 ago) @ Helmut Posting: # 7069 Views: 4,865 |
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Dear HS, Thank you so much for the insight, truly appreciate it. I've been following up regularly BEBAC and the postings are indeed informative and very helfpul. Cheers and more power! Thanks and regards. |
Ing. Helmut Schütz