ALA 8.33% 13.0¢ arovella therapeutics limited

Apart from needing to have a low conversion of Anagrelide to its...

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    Apart from needing to have a low conversion of Anagrelide to its active metabolite a lower administered dose may still result in same systemic exposure and subsequent adverse effects.

    Example: https://www.sciencedirect.com/science/article/pii/S0011393X19300013


    Of the942 patients treated with AGRYLIN, 161 (17%) were discontinued from the studybecause of adverse reactions or abnormal laboratory test results. The mostcommon adverse reactions resulting in treatment discontinuation were headache,diarrhea, edema, palpitations, and abdominal pain.
    https://www.rxlist.com/agrylin-side-effects-drug-center.htm#consumer


    Also see 3.7 Routes of Administration

    https://www.ema.europa.eu/en/documents/scientific-guideline/ich-s-3-toxicokinetics-guidance-assessing-systemic-exposure-toxicology-studies-step-5_en.pdf



 
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