pash413 ★ India, 2015-01-09 15:53 (3367 d 01:07 ago) Posting: # 14266 Views: 3,007 |
|
Dear all Please let us know how to administer Chewable Tablet in USFDA BE study. Product is OTC Chewable Tablet and label stats that "Chew the tablet" Whether tablet should be chewed and swallowed without water or with water or Swallow as a whole |
pravin17 ★ India, 2015-01-12 12:35 (3364 d 04:24 ago) @ pash413 Posting: # 14270 Views: 2,451 |
|
Dear Please refere OGD of that drug if not mentioned on OGD refer dosage administration section of prescribing information i.e. chew or swallow whole. Pravin Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
pash413 ★ India, 2015-01-13 07:46 (3363 d 09:14 ago) @ pravin17 Posting: # 14274 Views: 2,324 |
|
In OGD guidance administration procedure is not mentioned. Since it is OTC drug product label states that "Chew the tablet" My question is whether we have to administer water/not after chewing the tablet and how much time required to chew the tablet?? |
pash413 ★ India, 2015-01-16 12:37 (3360 d 04:23 ago) @ pash413 Posting: # 14297 Views: 2,461 |
|
Dear All Kindly guide |
Dr_Dan ★★ Germany, 2015-01-16 13:08 (3360 d 03:52 ago) @ pash413 Posting: # 14298 Views: 2,182 |
|
Dear pash413 If the reference medicinal product can be taken with or without water, bioequivalence should be demonstrated without water as this condition best resembles the intended use of the formulation. This is especially important if the substance may be dissolved and partly absorbed in the oral cavity. If bioequivalence is demonstrated when taken without water, bioequivalence when taken with water can be assumed. If bioequivalence between chewable test formulation taken without water and reference formulation with water is demonstrated in a 2-period study, bioequivalence of chewable taken with water can be assumed. In studies evaluating chewable tablets without water, it is recommended to wet the mouth by swallowing 20 ml of water directly before applying the chewable tablet on the tongue. It is recommended not to allow fluid intake earlier than 1 hour after administration. I hope this helps Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |