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jagankm ☆ 2011-04-26 15:22 (5543 d 05:56 ago) Posting: # 6939 Views: 6,214 |
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hello sir, i got one issue while designing BE study for metformin SR tablets. the issue is administration of 20% glucose containing water every 15 min till 4hrs after administration of dose. this is given in US draft guidlines of metformin. but when we plan a BE study for EMEA countries, is it necessary to fallow these guidlines or any specific EMEA guidlines available regarding administration of glucose solution.If we fallow US draft guidlines for EMEA BE study any problem with regulatory body? could you share your experience in this regards i will be thankfull to you sir, jagan mohan k |
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Helmut ★★★   Vienna, Austria, 2011-04-26 16:17 (5543 d 05:01 ago) @ jagankm Posting: # 6940 Views: 5,472 |
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Dear Jagan, you crossposted already at David’s PKPD-list. In case you didn’t receive my answer last Friday, see below: The difference between FDA and EMA is that FDA has published – besides the general guidances – 822 product specific guidances. Your study design should be based on science first. Do you really think that EMA wants you to risk hypoglycemic episodes in your study, just because nothing specifically to prevent them is stated in the European BE guideline? BTW, what do you think about following section of the GL (4.1.4 Study conduct, Standardisation): In rare cases, the use of a concomitant medication is needed for all subjects for safety […] reasons. Rose is a rose are guidelines — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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jagankm ☆ 2011-04-27 07:51 (5542 d 13:28 ago) @ Helmut Posting: # 6945 Views: 5,156 |
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Dear Sir, Thank you for your response. We are designing studies on normal healthy adult human volunteers under fed, fast and steady state fed conditions. dose administration: After an overnight fast of at least 08 hours, subjects will be served high fat high calorie vegetarian breakfast, which they are required to consume within 30 minutes. Dose will be administered at 30 ± 2 minutes after serving high fat high calorie vegetarian breakfast. The IMP will be administered to the subjects with 240 ± 2 mL of water containing 20% glucose. and further Subject will be provided 60 + 01 ml of water containing 20% glucose every 15 + 05 minutes till 4 hours post dose to prevent hypoglycaemia... But we are designing study for European countries. the administration 60ml glucose every 15min for 4hrs is as per USFDA metformin draft guidelines. But there is no EMEA guidelines stating that to administer glucose water to prevent hypoglycemia, my query is it ok to design study by keeping USFDA statement for EMEA study or any other specific EMEA guidlines stating regarding administration of glucose water? could you please help me in designing study of metformin for EMEA regulatory. thank you in advance for your response jagan Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
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Helmut ★★★ Vienna, Austria, 2011-04-27 14:34 (5542 d 06:44 ago) @ jagankm Posting: # 6947 Views: 5,057 |
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Dear Jagan, sit back, relax, and have a decent cup of tea… Print out this page and read my answer above again. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Ing. Helmut Schütz