Bioequivalence and Bioavailability Forum • Volume of distribution in steady state and Bioequivalence

javier
☆

Spain,
2016-09-14 18:18
(2770 d 18:28 ago)

Posting: # 16637
Views: 5,602

Volume of distribution in steady state and Bioequivalence [Design Issues]

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 (2769 d 21:02 ago) @ javier Posting: # 16643 Views: 4,605	Volume of distribution in steady state and Bioequivalence Post reply
	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 (2769 d 20:13 ago) @ javier Posting: # 16644 Views: 4,662	Vss definition Post reply
	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
(2763 d 18:08 ago)

@ mittyri
Posting: # 16663
Views: 3,404

Vss definition

Post reply

❝ 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!!