javier
☆    

Spain,
2016-09-14 18:18
(2752 d 21:59 ago)

Posting: # 16637
Views: 5,553
 

 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
(2752 d 00:33 ago)

@ javier
Posting: # 16643
Views: 4,567
 

 Volume of distribution in steady state and Bioequivalence

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
 

 Vss definition

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
[image]

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
 

 Vss definition

❝ 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!!
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