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Furthermore, these results point to the need for caution in choosing a suitable end point and animal model when seeking to test the estrogenic effects of xenobiotics.
Trials that had <7 days of follow-up, administered fructose intravenously, lacked an adequate carbohydrate comparator, or did not provide suitable end point data were excluded.
This is a suitable end point in oncology when a non-cytotoxic agent is used and a low objective response rate, along with a high stable disease rate, is expected (Llovet et al, 2008b; Adjei et al, 2009).
At key stages in the drug-development program, decision makers rely on the best rationale to select targets, drug candidates, trial designs, dose regimens, patient populations, and suitable end point measures.
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Identification of suitable end points not only would help investigators design appropriate clinical trials but would assist clinicians in caring for this patient population.
What, she asked, constitute other suitable end points?
Even though the future looks promising, carefully designed clinical trials in adults and children, with suitable end-points are still needed to confirm the efficacy, toxicity of these new agents, and improvements in quality of life of patients with β-thalassemia.
Vaccine development would be greatly facilitated by the identification of immune correlates of protection, the availability of accurate diagnostic tests for the definition of suitable end-points for efficacy and the development of additional paediatric vaccine trial sites.
pCR was a suitable surrogate end point for patients with luminal B/HER2−, HER2+, and triple-negative disease but not for tumors with luminal B/HER2+ or luminal A tumors.
If the end points were longer-term then the methodology we propose in this paper would require a suitable intermediate end point that was known to be correlated with the final end point.
von Minckwits and colleagues studied pCR and its prognostic impact on survival in intrinsic breast cancer subtypes and concluded that pCR is a suitable surrogate end point for patients with HER2+ (nonluminal) but not luminal B/HER2+ breast cancer [ 43].
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