Amira
☆    

Egypt,
2017-09-26 14:26
(2375 d 05:26 ago)

Posting: # 17829
Views: 6,159
 

 Atorvastatin intra-subject Variability [Study As­sess­ment]

Hello,

Atorvastatin Calcium is known as highly variable drug but when we conducted a BE study on it, the results gave low intra-subject Variability (18%) and that's inconsistent with the usual results.
What could be the reason/s for this?

Thank you.


Edit: Category changed; see also this post #1. [Helmut]
ElMaestro
★★★

Denmark,
2017-09-26 14:51
(2375 d 05:01 ago)

@ Amira
Posting: # 17830
Views: 4,913
 

 Atorvastatin intra-subject Variability

Hi Amira,

Chance?
Better assay?
Design differences?
Lesser within-batch variability (-ies) than in the studies you compare to?

Pass or fail!
ElMaestro
nobody
nothing

2017-09-27 12:11
(2374 d 07:41 ago)

@ ElMaestro
Posting: # 17832
Views: 4,907
 

 Atorvastatin intra-subject Variability

❝ Chance?

Maybe, but...

❝ Better assay?

No

❝ Design differences?

How?

❝ Lesser within-batch variability (-ies) than in the studies you compare to?

Variability has been attributed to various physiological sources, including e.g. liver function, transporter status:

https://www.ncbi.nlm.nih.gov/pubmed/22167570
https://www.ncbi.nlm.nih.gov/pubmed/21548957
https://www.ncbi.nlm.nih.gov/pubmed/20818835

Kindest regards, nobody
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2017-09-27 13:05
(2374 d 06:47 ago)

@ nobody
Posting: # 17833
Views: 4,893
 

 Atorvastatin intra-subject Variability

Hi ElMaestro & nobody,

❝ ❝ Chance?

❝ Maybe, but...


Quick calculations based on published CV (~35%), full replicate designs (n 40–64): Very, very unlikely; p <10–16.

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