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drmuneesh ★ 2009-08-10 18:43 (5752 d 07:41 ago) Posting: # 4031 Views: 9,849 |
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Dear All As most expiry dates are limited to month and year, so if the expiry date on medicines has just the month and year does that mean the expiry date is the last day of the previous month or the last day of the month shown on the container? Please suggest which date should be considered for clinical trials. Regards Dr Muneesh Garg Edit: Category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2009-08-10 18:52 (5752 d 07:33 ago) @ drmuneesh Posting: # 4032 Views: 8,759 |
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Dear Muneesh! ❝ [...] if the expiry date on medicines has just the month and year does that ❝ mean the expiry date is the last day of the previous month or the last day ❝ of the month shown on the container? The former. 12/2009 should be read as 'expiry date: Dec 31st, 2009'. — 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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drmuneesh ★ 2009-08-11 09:30 (5751 d 16:54 ago) @ Helmut Posting: # 4034 Views: 8,704 |
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Dear Helmut Hi Thank you very much for the response. We are planning a 4-period replicate study for a highly variable drug with a long washout of 30 days. But the reference product is getting expired in the month of the last dosing day. Can we go ahead with the study? And are there any guidelines/document stating that expiry date should be considered as the last day of the month written on the IP to avoid any regulatory queries in future? Best Regards Dr Muneesh Garg |
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Helmut ★★★ Vienna, Austria, 2009-08-11 16:22 (5751 d 10:03 ago) @ drmuneesh Posting: # 4036 Views: 8,907 |
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Dear Muneesh! ❝ We are planning a 4-period replicate study for a highly variable drug with ❝ a long washout of 30 days. But the reference product is getting expired in ❝ the month of the last dosing day. Can we go ahead with the study? Yes. But why are you going for a 4-period replicate design? Both FDA's recommendations (RSABE) and EU's requirements (widening of the acceptance ranage of Cmax) also allow for a 3-period study. Are you really interested in the intra-subject CV of the test product? Compared to the 4-period design you will need 50% more subjects to obtain the same statistical power (example: 2-period 64, 3-period 48, 4-period 32), but:
expecting a dropout-rate of 5%/washout we get
❝ And are there any guidelines/document stating that expiry date should be ❝ considered as the last day of the month written on the IP to avoid any ❝ regulatory queries in future? No one I know of. — 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 |
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drmuneesh ★ 2009-08-17 07:46 (5745 d 18:39 ago) @ Helmut Posting: # 4049 Views: 8,772 |
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Dear HS Thank you for the reply. We are planning 4-period replicate design to reduce the number of subjects also. Highly variable drug like risedronate having intrasubject variability of 50-80% would require too many subjects in case of 3-period design. 3-period design may be ok for drugs having intrasubject variability of 30-50%. Please suggest if I am wrong. Regards Dr Muneesh Garg |
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Helmut ★★★ Vienna, Austria, 2009-08-20 04:14 (5742 d 22:10 ago) @ drmuneesh Posting: # 4070 Views: 8,590 |
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Dear Muneesh! ❝ We are planning 4-period replicate design to reduce the number of subjects ❝ also. Highly variable drug like risedronate having intrasubject variability ❝ of 50-80% would require too many subjects in case of 3-period design. 3- ❝ period design may be ok for drugs having intrasubject variability of 30-50%. I don't see a difference (when it comes to the number of administered treatments) between CV 30-50% and 50-80%. What is more ethical: to administer N subjects four times or 1½N subjects three times? I just wanted to point out the higher chance of drop-outs, especially taking your long washout into account. On the other hand you may run into problems with the capacity of the clinical site (more groups, logistics). ❝ Please suggest if I am wrong. There's not right or wrong. Just different points of view. — 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 |
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drmuneesh ★ 2009-08-20 11:28 (5742 d 14:57 ago) @ Helmut Posting: # 4074 Views: 8,480 |
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Dear Helmut It is true that there are higher chances of drop-outs if we increase the number of periods, especially when there is long washout period. But I don't really know what is more ethical: to administer N subjects four times or 1½N subjects three times? I always thought that exposing less number of subjects to IP is more ethical. Thank you Best Regards Muneesh |
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Helmut ★★★ Vienna, Austria, 2009-08-20 16:05 (5742 d 10:20 ago) @ drmuneesh Posting: # 4078 Views: 8,527 |
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Dear Muneesh! ❝ But I don't really know what is more ethical: to administer N subjects ❝ four times or 1½N subjects three times? I always thought that exposing ❝ less number of subjects to IP is more ethical. I don't know either. From an ethical point of view, is there a difference in treating two subjects once or one subject twice? For any formulation there's a slight chance of SAEs (hypersentitivity to the API or excipients). From that perspective repeated administrations are definitely better. One the other hand in a four period study blood loss is higher and you are targeting at CVintra of the test formulation, which is not needed both for scaling (US) or widening of the acceptance range (EU). Quite interesting discussion! — 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 |
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drmuneesh ★ 2009-08-21 12:43 (5741 d 13:42 ago) @ Helmut Posting: # 4085 Views: 8,481 |
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Thank you so much for the guidance. Regards Muneesh |
Ing. Helmut Schütz