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Anand ☆ India, 2015-03-11 12:38 (4119 d 20:14 ago) Posting: # 14559 Views: 16,711 |
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Dear All, We are developing Pregabalin Capsules, We are going to file BCS based Bio-waiver approach by below data, Drug Solubility:
A.Anand Bio-PK Edit: Category changed. [Helmut] |
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Tina ★ India, 2015-03-11 18:27 (4119 d 14:26 ago) @ Anand Posting: # 14560 Views: 14,169 |
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Dear Anand, FDA's guidance on pregabalin (http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm162465.pdf) clearly states the following for BCS biowaiver route: It may be possible to request a waiver of in-vivo testing for all the strengths of this product provided that the appropriate documentation regarding high solubility, high permeability and rapid dissolution as detailed in the Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence for Immediate – Release Solid Oral Dosage Forms Based on the Biopharmaceutics Classification System is submitted in the application. You may use information contained in the approved labeling of the reference product. Peer reviewed articles may not contain the necessary details of the testing for the Agency to make a judgment regarding the quality of the studies. A decision regarding the acceptability of the waiver request can only be made upon review of the data submitted in the application. Essentially if data submitted satisfies the FDA requirement, it could be fine. Kind regards, Tina |
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Samaya B ☆ India, 2015-03-12 14:15 (4118 d 18:38 ago) @ Tina Posting: # 14561 Views: 14,122 |
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Dear Anand, In my opinion, Literature reference for permeability in terms of caco 2 cell permeability values should be acceptable to FDA. If this value is not directly available, you can define high permeability using absolute bioavailability, rapid and complete absorption after oral administartion, mass balance data / % of unchanged drug recovered, wide therapeutic window for said drug. Hope this would be helpful. Regards, Samaya. |
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luvblooms ★★ India, 2015-03-13 10:18 (4117 d 22:35 ago) @ Samaya B Posting: # 14563 Views: 14,042 |
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Dear Samaya ❝ In my opinion, Literature reference for permeability in terms of caco 2 cell permeability values should be acceptable to FDA. ❝ If this value is not directly available, you can define high permeability using absolute bioavailability, rapid and complete absorption after oral administartion, mass balance data / % of unchanged drug recovered, wide therapeutic window for said drug. In few cases FDA has not at all accepted the published literature information (even the Clinical Pharmacology and biopharmaceutics data of Inovator) so one need to be very cautious about that. Also if the product/molecule is highly variable, FDA will ask you to do a BE study. But in general for Pregabalin, these shall not be the concern!! Hope this will help. — ~A happy Soul~ |
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Maitri ☆ India, 2017-11-16 12:41 (3138 d 20:11 ago) @ luvblooms Posting: # 17984 Views: 8,696 |
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❝ In few cases FDA has not at all accepted the published literature information (even the Clinical Pharmacology and biopharmaceutics data of Inovator) so one need to be very cautious about that. Dear luvblooms, Can you just mentioned the few probable reasons for not accepting the published literature information? If the Clinical Pharmacology and biopharmaceutics data of Innovator clearly demonstrated a validated permeability study conducted using all the standards (low permeable, moderate permeable, high permeable, zero permeable) will it be acceptable in your opinion?  Thank You in advance!  Maitri 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 #5! [Helmut] |
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Dr_Dan ★★ Germany, 2015-03-12 14:49 (4118 d 18:03 ago) @ Anand Posting: # 14562 Views: 14,027 |
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Dear Anand The absolute bioavailability in humans is estimated to be more than 90%. (see EPAR Lyrica) Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz