qualityassurance ★ 2020-02-04 12:28 (1835 d 12:56 ago) Posting: # 21141 Views: 4,461 |
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Hello all, We have given concomitant medication to subjects during clinical phase and the route of administration was topical, local (eye drops), IV, IM. Can anyone suggest me ![]() ![]() |
jag009 ★★★ NJ, 2020-02-04 20:43 (1835 d 04:41 ago) @ qualityassurance Posting: # 21145 Views: 3,218 |
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❝ We have given concomitant medication to subjects during clinical phase and the route of administration was topical, local (eye drops), IV, IM. ❝ ❝ Can anyone suggest me Not sure if this answers your question(I think so but..): Why not? For both safety and bioanalytical reasons. J |
Ohlbe ★★★ France, 2020-02-05 11:13 (1834 d 14:10 ago) @ qualityassurance Posting: # 21147 Views: 3,207 |
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Dear Qualityassurance, ❝ Can anyone suggest me I would say it depends on the bioavailability of these products when administered by these routes. For IV, no discussion (at least, if there is an active substance - don't bother about saline or glucose). But for a topical administration the answer is likely that there is no point. — Regards Ohlbe |
Dr_Dan ★★ Germany, 2020-02-11 17:20 (1828 d 08:04 ago) @ qualityassurance Posting: # 21159 Views: 3,046 |
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Dear qualityassurance In case of a bioequivalence study, it also depends on whether the concomitant medication was given obligatory to all subjects or was taken accidentally by one or maybe more subjects. In the first case, the effect for the test and the reference formulation would be the same and you do not need to argue. Otherwise, a detailed risk analysis should be carried out, which describes the estimated PK effects of the concomitant medication on the bioequivalence decision. If only a view subjects are affected a sensitivity analysis could be carried out. I hope this helps. — Kind regards and have a nice day Dr_Dan |