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dixit ★ India, 2009-01-28 18:08 (5948 d 17:04 ago) Posting: # 3158 Views: 7,463 |
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Dear All, In a study performed on acarbose, glucose solution was administered to the volunteers who became hypoglycemic during the study. Now my question is if glucose solution is administered the blood glucose levels will increase. Will this effect the study performance. can we continue that subject in study or withdraw him from the study. Because the glucose levels may increase because of this additional administering of glucose solution. Thanks and Regards DIXIT  |
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MGR ★ India, 2009-01-29 07:51 (5948 d 03:22 ago) @ dixit Posting: # 3159 Views: 7,470 |
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Dear DIXIT, ❝ Now my question is if glucose solution is administered the blood glucose levels will increase. Will this effect the study performance. No there will be no effect on the study performance. ❝ can we continue that subject in study or withdraw him from the study. Because the glucose levels may increase because of this additional administering of glucose solution. We can continue the subject in the study as we are giving the glucose solution to increase the glucose level and after that we are giving the acarbose tablet to reduce those levels at which dosage (like 25mg, 50mg, 75mg or 100mg), as this study is doing as an escalation study. And one more thing is that you have to relax the parameters in the I/E criteria if necesaary before the protocol approval. Already we had done the Acarbose study. According to the FDA recommendation, we have to claim the BE with the dissolution tests itself w.r.t to the FDA given parameters. Another method which was given by the FDA itself is that we have to do the study with Pharmacodynamic dose escalation study to find out out at which dosage the acarbose is restricting the glucose levels. May be this helps. Thank you, — Regards, MGR |
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dixit ★ India, 2009-01-30 06:57 (5947 d 04:15 ago) @ MGR Posting: # 3164 Views: 5,559 |
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❝ Dear MGR,(ganesh) can u pls provide the link for guidance on conduct of acarbose study. Regards dixit  |
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MGR ★ India, 2009-02-03 06:48 (5943 d 04:24 ago) @ dixit Posting: # 3174 Views: 5,589 |
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Dear Dixit, Sorry. I can't provide link because we had asked a query by USFDA and they have sent it as a hard copy. So it is not possible for me to send the link. Thank you, — Regards, MGR |
Ing. Helmut Schütz