Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2018-02-26 01:05 UTC (UTC+2h)
 
Amira
Junior

Egypt,
2017-09-26 10:26

Posting: # 17829
Views: 1,221
 

 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
Hero

Denmark,
2017-09-26 10:51

@ Amira
Posting: # 17830
Views: 1,028
 

 Atorvastatin intra-subject Variability

Hi Amira,

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

I could be wrong, but…


Best regards,
ElMaestro

- Bootstrapping for dissolution data is a relatively new hobby of mine.
nobody
Senior

2017-09-27 08:11

@ ElMaestro
Posting: # 17832
Views: 983
 

 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
Hero
Homepage
Vienna, Austria,
2017-09-27 09:05

@ nobody
Posting: # 17833
Views: 986
 

 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.

[image]Regards,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
17,946 Posts in 3,823 Threads, 1,121 registered users;
23 users online (0 registered, 23 guests).

We have to remember that what we observe is not nature herself,
but nature exposed to our method of questioning.    Werner Heisenberg

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed