An open-label phase II dose optimization study of bosutinib at ......2016-0081 June 20, 2018 Page 1 An open-label phase II dose optimization study of bosutinib at a starting dose of
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HIGHLIGHTS OF PRESCRIBING INFORMATION --------------------- … · 2020-04-10 · Resume at same dose. • Grade 3 -1. Resume at same dose if first occurrence or reduce dose if recurrent.
Estimating the optimal dose of flupentixol decanoate in ...2016) Open-label non- comparison First episode, inpatient and outpatients (207) 12 months During study period N/A No Relapse
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Determination of the first dose for multispecific monoclonal … · 2017. 9. 17. · "Determination of the first dose for multispecific monoclonal antibodies: practical examples"
PHASE 2B ASTEROID STUDY 12-MONTH TOPLINE RESULTS …€¦ · SETRUSUMAB (BPS804) –ASTEROID STUDY 6 Treatment Period = 12 months 28 day screening High dose open label High dose blinded
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Consideration on the dose selection in different age groups and … · 2019. 7. 1. · 3 Off label use – Deficits of clinical studies Lack of paediatric dose recommendation in the
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First-in-human studies: Recent experiences in Europe · Dose 1 Dose 2 Dose n First-in-human SAD design NC data Toxicology PKPD Safety pharmacology 2007 . FIH discussion SOT 2017 2016