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raghavendra_s ★ 2011-05-31 13:37 (5500 d 21:48 ago) Posting: # 7031 Views: 6,016 |
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Dear Madam/Sir, I am currently planning a bioequivalence for our FDC product Ceftriaxone+Vancomcyin (Injection Formulation). In this regard, I have few queries I would like to ask my forum memebers. I am planning it as an open label, randomized, two treatment, two sequence, two period, single dose, cross over, comparative bioavailability study of FDC of Ceftriaxone+Vancomcyin and Rocephin® (Innovator) of Hoffmann – La Roche Inc., France & XXX (containing vancomycin) of ABC in 24+4 normal healthy, adult, human subjects under fasting conditions. Is this study design seems fine or else what better design I can put in ? What is the innovator product for Vancomycin? Is the sample size is correct ? FDC (test) product will be reconstituted with normal saline and administered through a peripheral venous catheter and the Reference products (each separately) will be reconstituted with normal saline separately and both of them were infused simultaneously through a dual line peripheral venous catheter. Am doing it right? What type of bioanalytical methods HPLC or LC-MS/MS preferable? Please suggest. Thanks and regards, Raghav |
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Dr_Dan ★★ Germany, 2011-05-31 15:03 (5500 d 20:22 ago) @ raghavendra_s Posting: # 7032 Views: 4,839 |
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Dear Raghav Could you please explain why do you think that a bioequivalence study is needed? Please note there is no disintegration, dissolution and absorption. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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raghavendra_s ★ 2011-05-31 15:23 (5500 d 20:03 ago) @ Dr_Dan Posting: # 7033 Views: 4,804 |
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❝ Could you please explain why do you think that a bioequivalence study is needed? Please note there is no disintegration, dissolution and absorption. Dear Dr Dan, Can't we propose a bioequivalence to regulatory authorities for newer FDC even if the route of administration is IV to investigate or prove that when clubbed each individual component would not have any impact on each other's fate in the body? Correct me if Iam wrong. How to prove the fractional maximal effect (FME) of synergestic fdc combination. Thanks and kind regards, |
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Dr_Dan ★★ Germany, 2011-06-01 13:54 (5499 d 21:31 ago) @ raghavendra_s Posting: # 7049 Views: 4,731 |
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Dear Raghav IMHO the question you need to answer is not bioequivalence but interaction. First you have to ensure in vitro that your combi formulation is as stable as both mono formulations and that both APIs do not interact chemically. From a clinical point of view you first have to decide if it is reasonable to administer both compounds at the same time. If yes it is interesting to know if there is a pharmacological interaction. To investigate this you need a bioavailability (interaction) study with the following design: Randomised 3 way 3 period cross-over Treatment A: mono formulation 1 Treatment B: mono formulation 2 Treatment C: kombi formulation (1+2) I hope this helps. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz