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kranti ☆ India, 2013-06-19 11:39 (4753 d 03:27 ago) Posting: # 10814 Views: 5,851 |
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Dear Friends, We have to conduct a comparative bio availability study of Test Vs Reference, to prove superiority of our product against the reference. The reference product of same strength as of test product is not available in market. So Can we use 1 tablet of Test (5 mg Fast Dissolve Tablet) for comparing against the 5 tablets of reference (1 mg Immediate release Tablet) Your response will be highly appreciated. Thanks and Regards |
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Dr_Dan ★★ Germany, 2013-06-19 14:49 (4753 d 00:17 ago) @ kranti Posting: # 10817 Views: 4,947 |
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Dear Kranti How do you want to demonstrate superiority of your product, if no reference product (in the same strength) is available? What do you mean by superiority? Higher bioavailability? However, you will need clinical data and superiority can only be claimed in case of higher clinical efficacy, the concept of bioequivalence or just the demonstration of higher bioavalability is not applicable. BTW could you explain your definitions of fast dissolve tablet in contrast to immediate release tablet? IMHO IR formulations are conventional formulations (=no MR or orodispersible formulations) which could be very rapid (> 85 % within 15 min at all 3 pH levels) or rapid (85 % within 30 min at all 3 pH levels) or slower. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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kranti ☆ India, 2013-06-19 15:56 (4752 d 23:10 ago) @ Dr_Dan Posting: # 10818 Views: 4,942 |
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Dear Dan, Thanks for the reply Our test product is a nutraceutical product, which can be marketed without any approval from regulatory, as per DSHEA. So our test product is already present in market, and we have to prove that it has superior bio availability as compared to the reference product. We can use the positive results of this study as a marketing tool for our product. Our test product is a ODT and reference is a conventional formulation. thanks and regards Kranti |
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jag009 ★★★ NJ, 2013-06-19 21:54 (4752 d 17:12 ago) @ kranti Posting: # 10829 Views: 4,860 |
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Hi, ❝ Our test product is a nutraceutical product, which can be marketed without any approval from regulatory, as per DSHEA. So our test product is already present in market, and we have to prove that it has superior bio availability as compared to the reference product. We can use the positive results of this study as a marketing tool for our product. ❝ ❝ Our test product is a ODT and reference is a conventional formulation. Questions: Define Superiority. You mean for example your test/Ref Ratio in AUC would yield > 100%? If so 1) you might have to make justification that your dose is safe and tolerable if 5 mg is the max dose (not strength) of the RLD. If not then you have to dose adjust your product to give similar bio to the reference, like your product is 4 mg ODT and give equivalent peak and systemic exposure relative to RLD 5mg. I think you can dose the reference as 5x1mg if the 5mg does not exist (but 5 mg dose must be within the max recommended dose). Note that this will not be an ANDA (generic filing). You are presenting a different platform and use a non-RLD. I could be wrong since I don't deal with any agency outside FDA and TPD (and I don't deal with nutra stuff). I have done ODTs but we always claimed equivalency to a reference (and the filings were not ANDAs). John |
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Dr_Dan ★★ Germany, 2013-06-20 11:53 (4752 d 03:13 ago) @ kranti Posting: # 10836 Views: 4,869 |
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Dear Kranti The information, that your test product is a nutraceutical product, which can be marketed without any approval from regulatory makes a huge difference. As John pointed out you just need to justify that the intended higher bioavailability with the ODT in the same strength as the RLD (peak plasma levels and total bioavailability) is safe and tolerable. Then it should be possible to demonstrate superiority (higher bio availability) as marketing tool for your ODT. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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kranti ☆ India, 2013-06-24 12:45 (4748 d 02:21 ago) @ Dr_Dan Posting: # 10869 Views: 4,840 |
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Mr. John and Dr. Dan...  Thanks a alot for the reply... |
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kumarnaidu ★ Mumbai, India, 2013-11-12 11:58 (4607 d 02:09 ago) @ kranti Posting: # 11869 Views: 4,468 |
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Dear all, I want to calculate sample size for the BE study of dispersible tablets. Can I consider MHRA report of powder for oral suspension here, because no literature present for dispersible tablets of desired strength. — Kumar Naidu |
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Dr_Dan ★★ Germany, 2013-11-13 12:46 (4606 d 01:20 ago) @ kumarnaidu Posting: # 11875 Views: 4,417 |
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Dear Kumar Naidu Both formulations are IR formulation. Your orodispersable tablet (ODT) is formulated to quickly disperse in the mouth. In case of a low soluble drug (and your drug is such a BCS class II or IV drug, otherwise the reference would not be a suspension but a solution) there should be no problem to calculate sample size based on the other formulation as long as your ODT is taken with water. I hope this helps. Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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kumarnaidu ★ Mumbai, India, 2013-11-14 07:29 (4605 d 06:37 ago) @ Dr_Dan Posting: # 11881 Views: 4,556 |
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Thanks Dr_Dan for your guidance. — Kumar Naidu |
Ing. Helmut Schütz