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Compliance ★ India, 2014-03-19 06:12 (4482 d 12:35 ago) Posting: # 12660 Views: 4,217 |
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Dear All, As per the draft guidance on PK study (US FDA) sprinkle study is suggested for modified release formulation. Now my question is what to do if the label of IR formulation suggest to do the sprinkle study which is not cover in draft guidance. (I am going to conduct study of Celecoxib 400 mg and RLD is Celebrex). Regards, Compliance |
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Mahesh M ★ India, 2014-03-19 12:35 (4482 d 06:12 ago) @ Compliance Posting: # 12665 Views: 3,562 |
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Dear Compliance, For immediate-release (IR) drug products labeled for sprinkle, it is generally not necessary to conduct a sprinkle BE study, as the expectation would be that the sprinkles would behave similarly for the test and RLD IR products. Regards Mahesh |
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Dr_Dan ★★ Germany, 2014-03-19 12:51 (4482 d 05:56 ago) @ Compliance Posting: # 12667 Views: 3,543 |
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— Kind regards and have a nice day Dr_Dan |
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Compliance ★ India, 2014-03-20 08:05 (4481 d 10:42 ago) @ Dr_Dan Posting: # 12673 Views: 3,488 |
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Dear Dr. Dan, we are following recommendation but the only thing is in past FDA asked us to to conduct sprinkle due to change in the label and hold our application. Due to this this question comes. However thanks for your concern. Regards, Compliance |
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jag009 ★★★ NJ, 2014-03-20 17:35 (4481 d 01:11 ago) @ Compliance Posting: # 12680 Views: 3,487 |
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Hi, ❝ we are following recommendation but the only thing is in past FDA asked us to to conduct sprinkle due to change in the label and hold our application... Why not send in a control correspondence to FDA and get an answer from them about the label having mentioned a sprinkled study if you don't want to get screwed again. John |
Ing. Helmut Schütz