john john
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Spain,
2015-05-06 14:16
(3250 d 03:07 ago)

Posting: # 14756
Views: 13,597
 

 CV inter-subject [Power / Sample Size]

Hullo

I'm looking for the inter-subject variability of the Cmax of oral hydroxychloroquine. Thanks


Edit: Category changed. [Helmut]
Helmut
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Vienna, Austria,
2015-05-06 15:18
(3250 d 02:05 ago)

@ john john
Posting: # 14760
Views: 13,252
 

 Hydroxychloroquine

Hi John(s),

❝ I'm looking for the inter-subject variability of the Cmax of oral hydroxychloroquine.


I guess you mean CVtotal? CVinter is only accessible in a crossover study. BE studies of hydroxy­chloro­quine are performed in a parallel design due to its long half-life.
In the future please :google: first.
If the CV was not given, I calculated it from the CIs and sample sizes:

Ref.  n   PK metric   PE      90% CI     CVtotal
 1   72   Cmax        97.1%  86.4–109.2%  29.8%
          AUClast*    94.3%  84.2–105.7%  29.0%
 2   72   Cmax        90.8%  79.3–104%    35.6%
          AUC0-72     99.5%  87.4–113%    33.6%
 3   54   Cmax        99.3%  98.1–102.1%   4.4%
          AUC0-24     99.7%  98.9–101.4%   2.7%


Liu’s CVs are simply bizarre. Unbelievable that such a paper passed the peer-review.


  • Blood was harvested for 11 weeks.
  1. Midha KK, Rawson MJ, Hubbard JW. Bioequivalence: Issues and Options. J Pharmacokin Biopharm. 1997;25(6):743–52.
  2. MHRA. Public Assessment Report: Hydroxychloroquine Sulphate 200mg Film-Coated Tablets. PL 17907/0017 (2007)
    online
  3. Liu YM et al. A Parallel Design Study to Assess the Bioequivalence of Generic and Branded Hydroxychloroquine Sulfate Tablets in Healthy Volunteers. Arzneim Forsch / Drug Res. 2012;62(12):644–9. doi:10.1055/s-0032-1329962.

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john john
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Spain,
2015-05-06 15:28
(3250 d 01:55 ago)

@ Helmut
Posting: # 14761
Views: 12,038
 

 Hydroxychloroquine

Hi Helmut

I want the CV inter-subject to calculate the sample size for a parallel design
I'm wrong? Thans
John (2)


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! [Ohlbe]
Helmut
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Vienna, Austria,
2015-05-06 17:40
(3249 d 23:43 ago)

@ john john
Posting: # 14764
Views: 12,035
 

 pooled / total CV

Hi John × 2

❝ I want the CV inter-subject to calculate the sample size for a parallel design


Nope. You definitely want the total (aka pooled) one. The fact that you observe the PK-re­sponse only once in a parallel design does not remove the intra-subject variability. Therefore, what you observe consists of both inter- and intra-subject components.

❝ I'm wrong?


Yes. See this post.

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nobody
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2015-05-06 19:50
(3249 d 21:33 ago)

@ Helmut
Posting: # 14765
Views: 11,918
 

 Hydroxychloroquine

 3   54   Cmax        99.3%  98.1–102.1%   4.4%

          AUC0-24     99.7%  98.9–101.4%   2.7%


❝ Liu’s CVs are simply bizarre. Unbelievable that such a paper passed the peer-review.


sorry for OT, but this is really, really, really, really.... strange ;-) How about a letter to the editor with exactly this question. Something like that should not go unopposed, at least with showing all raw data (really raw)...

Kindest regards, nobody
Helmut
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2015-05-06 20:21
(3249 d 21:02 ago)

@ nobody
Posting: # 14767
Views: 11,870
 

 Lousy review process

Hi nobody,

❝ sorry for OT, but this is really, really, really, really.... strange ;-)


Even with a fancy bioanalytical method we rarely see a CV of <5%. 4.4% of Cmax in a parallel design? Gimme a break. :not really:

❝ How about a letter to the editor with exactly this question. Something like that should not go unopposed, at least with showing all raw data (really raw)...


Grumpy mood? Do you have a budget to buy the paper?

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nobody
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2015-05-06 20:47
(3249 d 20:36 ago)

@ Helmut
Posting: # 14768
Views: 11,913
 

 Lousy review process

❝ Grumpy mood? Do you have a budget to buy the paper?


so to say... little sick of fancy 2% CV studies...

I ordered it, may take a few days ;-)

Edith: ...and sent an email to the first author, see if we can get some details.

Kindest regards, nobody
Helmut
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2015-05-06 20:50
(3249 d 20:32 ago)

@ nobody
Posting: # 14769
Views: 11,863
 

 Lousy review process

Hi nobody,

❝ ❝ Grumpy mood? Do you have a budget to buy the paper?


❝ so to say... little sick of fancy 2% CV studies...


Do you know more?

❝ I ordered it, may take a few days ;-)


Fine. BTW, the database-admin worked on the timeshift. No Δ 13 min anymore – only 1 min.

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nobody
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2015-05-06 20:57
(3249 d 20:26 ago)

@ Helmut
Posting: # 14770
Views: 11,815
 

 Lousy review process

❝ ❝ so to say... little sick of fancy 2% CV studies...


❝ Do you know more?


Not in the public domain... ;-)

Kindest regards, nobody
nobody
nothing

2015-05-28 17:53
(3227 d 23:30 ago)

@ Helmut
Posting: # 14872
Views: 11,358
 

 Lousy review process

❝ Even in a fancy bioanalytic method we rarely see a CV of <5%. 4.4% of Cmax in a parallel design? Gimme a break. :not really:


OT, but slightly on topic, maybe, at least a little bit:

http://www.sciencemag.org/content/342/6154/60.full

Kindest regards, nobody
Helmut
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2015-05-28 18:00
(3227 d 23:23 ago)

@ nobody
Posting: # 14873
Views: 11,318
 

 Lousy review process

Hi nobody,

❝ OT, but slightly on topic, maybe, at least a little bit:


http://www.sciencemag.org/content/342/6154/60.full


Yep. See also this post and linked references. :-D

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nobody
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2015-05-28 18:10
(3227 d 23:13 ago)

@ Helmut
Posting: # 14874
Views: 11,371
 

 Lousy review process

❝ ❝ OT, but slightly on topic, maybe, at least a little bit:

❝ ❝

❝ ❝ http://www.sciencemag.org/content/342/6154/60.full


❝ Yep. See also this post and linked references. :-D


... I'm obviously ALWAYS second in this forum... Do I spent to much time elsewhere? :lookaround:

Kindest regards, nobody
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