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luvblooms ★★ India, 2011-07-30 09:41 (5436 d 22:54 ago) Posting: # 7239 Views: 7,969 |
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Dear All Regards We are planning for an IVIVC study for a Extended release formulation of BCS class I drug. And the designed what we are thinking of is like this "An open label, balanced, randomized, Four-treatment, four-period, four-sequence, single oral dose, four way crossover bioequivalence study of four formulations of XXX extended release tablets in healthy, adult, human subjects under fasting conditions." In the study, we will be using 3 test formulation, with slow, medium and fast release against reference product. Whether this design is sufficient enough for IVIVC? Or we have to add one more arm (Oral solution/IV) as Internal validation? Kindly help me out!!  Luv — ~A happy Soul~ |
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GSTATS ☆  India, 2011-08-02 12:46 (5433 d 19:49 ago) @ luvblooms Posting: # 7249 Views: 6,436 |
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Dear Luvblooms ❝ "An open label, balanced, randomized, Four-treatment, four-period, four-sequence, single oral dose, four way crossover bioequivalence study of four formulations of XXX extended release tablets in healthy, adult, human subjects under fasting conditions." ❝ ❝ In the study, we will be using 3 test formulation, with slow, medium and fast release against reference product. ❝ ❝ Whether this design is sufficient enough for IVIVC? Yes, for Unit impulse response (UIR) calculation, one more arm with IR/IV is required. But data from literature or any previous study for IR/IV can also be used in calculations, if available. Regards, GSTATS — Let Noble Thoughts come from Every Side: RIG VEDA |
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jagankm ☆ 2012-06-26 15:49 (5104 d 16:46 ago) @ GSTATS Posting: # 8850 Views: 5,619 |
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Dear GSTATS, ❝ Yes, for Unit impulse response (UIR) calculation, one more arm with IR/IV is required. But data from literature or any previous study for IR/IV can also be used in calculations, if available. Could you guide us how to calculate UIR by using IR/IV data by using winnonlin 5.3 version. Can anybody guide me regarding any literature regarding UIR calculation in deconvolution in IVIVC. |
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SDavis ★★ UK, 2012-06-28 22:36 (5102 d 09:59 ago) @ jagankm Posting: # 8861 Views: 5,495 |
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WinNonlin comes with an Examples guide have you tried following that? I would also highly recommend you plan to upgrade to the current version of WinNonlin, Phoenix WinNonlin 6.3 as soon as possible; it was released at the end of March 2012. Simon The next release is planned for q1/q2 2013, but will primarily focus on Trial Simulator integration. Edit: See also here. [Helmut] — Simon Senior Scientific Trainer, Certara™ [link=https://www.youtube.com/watch?v=xX-yCO5Rzag[/link] https://www.certarauniversity.com/dashboard https://support.certara.com/forums/ |
Ing. Helmut Schütz