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Re: dewophile post# 126

Monday, 12/18/2006 1:02:59 PM

Monday, December 18, 2006 1:02:59 PM

Post# of 3757
Dose modifications of ribavirin are spelled out in detail in the FDA labels for Rebetol and Copegus (the SGP and Roche brands of ribavirin):

http://www.fda.gov/cder/foi/label/2006/020903s038lbl.pdf
http://www.fda.gov/cder/foi/label/2005/021511s012lbl.pdf

For the reasons mentioned in message #121, I think HCV clinical trials that include ribavirin will stay as close as possible to the ribavirin label. Dose modification will ultimately be at the clinician’s discretion, but the clinicians will presumably strive to follow the label as closely as they can. Regards, Dew

p.s. flatlander is new to this board, but he’s a longstanding contributor on the NVS board on Yahoo, which has at times been a lonely place. Hence my question about NVS in the prior message here in reply to FL.

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