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taresh41 ☆ Mumbai, 2009-06-24 10:46 (6213 d 22:27 ago) (edited on 2009-06-24 13:25) Posting: # 3895 Views: 3,045 |
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Dear all, I am intrested in knowing about conduct of "bioavailability studies comparing 1 sustained release tablet versus 2 immediate release tablets (dosed twice)". The SR tablet (e.g.: strength 20 mg) is dosed once while the IR tablet is dosed twice i.e. 1st 10 mg IR tablet at the time when 20 mg of SR tab is dosed and 2nd 10 mg IR tablet 12 hours after dosing. Please explain?
Taresh -- Edit: Please don't use capital letters only - bold format is enough (see the Policy). [Helmut] |
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Jaime_R ★★ Barcelona, 2009-06-24 15:22 (6213 d 17:51 ago) @ taresh41 Posting: # 3897 Views: 2,493 |
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Hi Taresh! ❝ 1. Need of comparing SR formulation with a IR formulation? More infos please. Is there already another SR formulation on the market? Same/other galenic principle? ❝ 2. Are there any regulatory guidances which give the procedure for conduct ❝ for this study? Please do your homework first! For example have a look at the appendix of the European guideline. — Regards, Jaime |
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taresh41 ☆ Mumbai, 2009-06-25 09:27 (6212 d 23:47 ago) @ Jaime_R Posting: # 3899 Views: 2,452 |
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Dear Jaime, Thanks for anserwing the second question, Regarding the first question, Please explain me from both ends i.e. Do we need to perform BE study comparing SR formulation with an IR formulation if, 1) If there is no other SR formulation available in market? — Thanks & Regards, Taresh |
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Jaime_R ★★ Barcelona, 2009-06-25 12:07 (6212 d 21:06 ago) @ taresh41 Posting: # 3901 Views: 2,513 |
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Hi Taresh, I'm not willing to start a back-and-forth-question-game. Did you have a look at the European Guideline as suggested? — Regards, Jaime |
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taresh41 ☆ Mumbai, 2009-06-25 15:26 (6212 d 17:47 ago) (edited on 2009-06-26 05:32) @ Jaime_R Posting: # 3903 Views: 2,479 |
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Hi Jaime, Got it! Thanks. — Thanks & Regards, Taresh |
Ing. Helmut Schütz