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NVP ☆ 2011-03-29 19:53 (5569 d 21:37 ago) Posting: # 6830 Views: 6,507 |
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For Chewable tablet development for Brazil, US, EU, in bioequivalence study what should be the method of administration? It should be chewed or not? Is it given with water or without ? |
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Helmut ★★★   Vienna, Austria, 2011-03-29 20:36 (5569 d 20:54 ago) @ NVP Posting: # 6831 Views: 5,931 |
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— 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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NVP ☆ 2011-03-31 18:39 (5567 d 22:51 ago) @ Helmut Posting: # 6845 Views: 5,744 |
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thanks for reply. Link is about EU but what about US and BRAZIL ? |
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ratnakar1811 ★ India, 2011-04-13 10:51 (5555 d 06:39 ago) @ Helmut Posting: # 6891 Views: 5,471 |
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Dear HS & Other forum Members, Agreed that the studies to be conducted according to the recommended use, my question is what about the test product in chewable tablet form, in this situation if you ask volunteer to chew the tablet, what time should you consider as the time of administration of IMP as it may take time (about 2 to 5 min or some times more also depending upon the formulation) to completely chew the tablet also the chances of non compliance will be more sometimes tablet may stick to the teeth or under tongue, also there are chances that volunteer may swallow tablet in between, the same problems are also applicable to the IMP available in chewing gum e.g Nicotine gum. Valuable comments from anybody having experience of conducting such studies will be highly appreciated. Regards, Ratnakar |
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bharathi ☆ India, 2012-03-20 07:56 (5213 d 08:34 ago) @ ratnakar1811 Posting: # 8303 Views: 4,682 |
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Dear Ratnakar, BE studies should reflect the recommended use - For example - Nicotine Chewing Gum PIL says - 1) Chew, park, Chew Chew (when you have urge to smoke (chewing releases nicotine)) Park (rest between gum and cheek) Chew (when you have again urge to smoke) So your study should reflect this (Chew-Park-Chew) As urge to smoke depends on the individual, to harmonize, we need to fix the chewing rate and chewing time for the study Eg: - 10 chews/min for 15 minutes 2) "Don't eat or drink for 15 minutes before chewing nicotine gum" Instruct subjects not to take water for a particular time before and after dosing In the same way - Chewing tablet - 1) Harmonize Chewing rate - Place tablet on the tongue - suck - move to the right cheek - Place on the tongue - suck - move to left cheek …………….until tablet gets dissolved completely Eg: For every 10 seconds move from one side to the other (sucking once) until the tablet completely dissolves Instruct subjects not to chew or swallow the gum/tablet; if so eliminate them from the study Hope you understood the concept Regards, Bharathi |
Ing. Helmut Schütz