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Broad anti-tumour activity shown in preclinical studies has been confirmed in phase I/II studies for irinotecan and topotecan.
Although the safety and efficacy of HAI using powdered CDDP have been confirmed in Phase II studies [ 10], there are no reports indicating the ideal infusion profile.
Once the initial safety of the drug candidate has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20 to 300), this time of patients.
Initial exciting data suggesting that iniparib improved outcome in patients with triple-negative breast cancer in combination with chemotherapy have not been confirmed in phase III studies, although there are clearly patients who benefit from this agent.
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The biological data were confirmed in Phase II of the Anticonvulsant Drug Development Program of the National Institute of Health.
After background correction, positive ROIs were demarcated only on somata whose integrity was confirmed in phase contrast images.
And now its efficacy against liver fibrosis was confirmed in phase II clinical trial carried out in US (http://www.clinicaltrials.gov).gov
However, this needs to be confirmed in phase III trials where a larger sample size, and PK sampling will enable a more robust characterization of covariate relationships, especially relating to any potential effects of weight on the PK.
This was confirmed in phase two with midwives and CFH nurses reporting that discharge summaries lacked important information on client social and emotional problems and other individualised client information.
However, if its good tolerability profile and effectiveness are confirmed in phase III studies, aliskiren may be a cost-effective option in the treatment of hypertension, especially in patient populations where it may prove to have a therapeutic advantage, e.g. patients with diabetic nephropathy.
The efficacy of sorafenib on RCC has been confirmed in both phase II and phase III trials, which had resulted in the approval of its use as a second-line treatment in metastatic disease [ 6, 7].
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Justyna Jupowicz-Kozak
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