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Dear All,
Could someone provide information about intrasubject variability of
Cmax and AUC of single dose study with pravastatin.
There is a BE study published in 2004 that enrolled 24 subjects, but
I has found some information about variability of its pharmacokinetic
data .
Regards,
Daniel Rossi de Campos
Brazil
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Intra subject variability under fed or fasted condition observed for
Cmax was about 31 % and AUC was app. 20 %.
Hope, this will help.
Regards.
Jayanta Mandal
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Hi Daniel.
We have done quite amount of studies for pravastatin either 2 way
crossover or replicate design. Usually, the CV for AUC is from 20 to
25% and for Cmax is from 30 to 35%. We are very experience on this
drug, please do not hesitate contacting me if we can assist you further.
Regards,
Ms. Juan He, MSc.Phm
Director, Pharmacokinetics and Statistics
Biovail Contract Research
460 Comstock Road
Toronto, Ontario
Canada, M1L 4S4
416-752-3636/367
juan.he.-at-.biovail.com
www.biovail-cro.com
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