alagu
☆    

India,
2013-09-07 13:19
(4674 d 04:29 ago)

Posting: # 11455
Views: 4,793
 

 Statin Intra subject variability [Design Issues]

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Dear All,

Let me Know the Statin Variability in Fast & Fed condition. Please share your experience?
  1. Intra subject variability of Atorvastatin 40mg is 28.7% for Cmax & ISCV for Atorvastatin 80mg will same or it will be varying?

  2. ISCV based on Molecule or Strenth it will varying?

Regards,
AR_A

Edit: Category changed; #1–2 merged from a later post. [Helmut]
 
Dr_Dan
★★  

Germany,
2013-09-07 21:50
(4673 d 19:58 ago)

@ alagu
Posting: # 11460
Views: 4,041
 

 Statin Intra subject variability

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Dear AR_A
The intra-subject variability varies a little bit from study to study and if you repeat your study with atorvastatin 40 mg it will most likely not be 28.7% again. However it should not be very different, if you use the same formulation, same study population, same bioanalytical method etc..
The intra-subject variability is a substance/formulation specific parameter. If you use a different strength (80 mg) of the same formulation you can calculate with the same intra-subject variability.
Kind regards
Dan
—
Kind regards and have a nice day
Dr_Dan
 
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