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Home » Shire Web-Based Dosing Software Achieves FDA Clearance
Shire Web-Based Dosing Software Achieves FDA Clearance
![ClearanceStamp_Gray.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Gray.gif?t=1576043982&width=430)
December 27, 2017
Shire received 510(k) marketing clearance for its web-based dosing software for patients with hemophilia A treated with ADVATE.
The mPKFit estimates a patient’s pharmacokinetic profile using just two measurable blood samples — compared to the 9 to 11 samples recommended by the International Society on Thrombosis and Haemostasis — enabling clinicians to tailor treatments to the individual patients.
The severity of hemophilia A is determined by assessing the amount of factor in the blood, with more severity associated with lower amounts of factor.
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