javier ☆ Spain, 2016-09-14 18:18 (2752 d 21:59 ago) Posting: # 16637 Views: 5,553 |
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Hi again! After more time than I would have liked to see, Im coming back to the forum with one question about BE studies I was reading an article about PK study single dose Healthy volunteers comparing the two drugs,and I was surprised by the Vdss as one pharmacokinetic parameter to match Bioequivalence I thought Steady state is more appropriate for a multiple dose study, when you can observe the steady state equilibrium (after 3-5 half lives) So if someone can enlighten about it, i would appreciate it very much Kinds regards Javier |
BE-proff ● 2016-09-15 15:45 (2752 d 00:33 ago) @ javier Posting: # 16643 Views: 4,567 |
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Hi javier, I think you are talking about a scientific article in a journal. I have never seen Vd as BE criterion in relevant guides so it might have only scientific interest |
mittyri ★★ Russia, 2016-09-15 16:33 (2751 d 23:44 ago) @ javier Posting: # 16644 Views: 4,624 |
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Hi Javier, I don't know the reason of using this metric in the article you're reading. But I would cite a classic one1 So you don't need MD data to get Vss. By the way be aware! Only bolus/infusion data are apllicable (see here) 1. Gibaldi M, D Perrier D. Pharmacokinetics. New York: Marcel Dekker; 2nd ed. 1982 — Kind regards, Mittyri |
javier ☆ Spain, 2016-09-21 18:39 (2745 d 21:38 ago) @ mittyri Posting: # 16663 Views: 3,364 |
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❝ I don't know the reason of using this metric in the article you're reading. me neither really, its about pharmacokinetics between a innovator and a generic drugs in a single dose with a drug's infusion of 60 minutes. ❝ ❝ But I would cite a classic one1 ❝ ❝ ❝ So you don't need MD data to get Vss. By the way be aware! Only bolus/infusion data are apllicable (see here) ❝ ❝ ❝ 1. Gibaldi M, D Perrier D. Pharmacokinetics. New York: Marcel Dekker; 2nd ed. 1982 Thanks you very much for your time, this answer is awesome. In my opinion, they use this pk parameter because with it they dont need to use a bicompartmental model to analize de data, only the non-compartmental one. (may be for money) Thanks again!! |