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Debbie ★ India, 2011-01-31 17:38 (5629 d 20:23 ago) Posting: # 6521 Views: 7,502 |
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Hi, As per the european guidelines, the parent compound (not metabolite) should be used for bioequivalence evaluation and in case of prodrugs the metabolite may be used for bioequivalence. Aspirin is metabolised to salicylic acid in the body and for the BE assessment whether aspirin (parent) or salicylic acid (metabolite) shall be used for the BE study for EU submission. From the literature it was observed that the concentrations of aspirin were observed for only 3 to 4 hours after drug adminsitration and later on the concentration of salicylic acid is predominently available for about 10 to 12 hours. Please provide your opinion for the selection of aspirin or salicylic acid as the analyte for BE comparision. Regards |
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ElMaestro ★★★ Denmark, 2011-01-31 17:59 (5629 d 20:02 ago) @ Debbie Posting: # 6522 Views: 6,394 |
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Hi, ❝ From the literature it was ❝ observed that the concentrations of aspirin were observed for only 3 to 4 ❝ hours after drug adminsitration and later on the concentration of ❝ salicylic acid is predominently available for about 10 to 12 hours. The use of metabolites comes in handy when the parent compound is metabolised too fast for reliable assessment of a Conc vs. time curve. I have not read any literature, but in case your parent is in the blood for up to 4 hours I would imagine you can get good Cmax and AUC readings of it. If this is the case, I'd use only the parent compound. — Pass or fail! ElMaestro |
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Ohlbe ★★★ France, 2011-02-01 00:34 (5629 d 13:27 ago) @ Debbie Posting: # 6523 Views: 5,384 |
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Dear Debbie, If your submission is intended for the EU market, why not try a biowaiver ? I would say most, if not all, EU Member States would accept a dossier without a BE for aspirin. Or is it a modified release formulation you are dealing with ? Regards Ohlbe — Regards Ohlbe |
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Debbie ★ India, 2011-02-01 17:36 (5628 d 20:25 ago) @ Ohlbe Posting: # 6530 Views: 5,348 |
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Hi, my formulation is the combination of aspirin and dipyridamole. The bioequivalence criteria to be evalauted for dipyridamole and acetyl salicylic acid or salicylic acid? Regards, Debbie |
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manan ☆ Ahmedabad, 2011-02-02 08:06 (5628 d 05:55 ago) @ Debbie Posting: # 6534 Views: 5,236 |
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Dear Debbie The BE can be determined using acetly salicylic acid and dipyridamole. salicylic acid can be used for supportive basis you can also go ahaed with a multiple dose steady state trial. |
Ing. Helmut Schütz