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【Clinical】What are the review considerations for "selection of dose, administration method " for clinical trials?

刊登日期:2019-11-11  |  點閱次數 : 712 次 

Evaluation of the appropriateness of administration method and dose selection is based on scientific approach. If the trial is a phase III clinical trial, the results of the dose-response trial or pre-clinical trial may be referenced. If the study drug is at the early development stage, the appropriateness of administration method and dose selection may be inferred from the results of toxicological or pharmacokinetic studies. The doses used and treatment duration reported in the completed trials will be carefully considered for evaluation of the risk of this trial and possible treatment effect. Whether the adverse reaction is dose-related will also be evaluated.

 

Some study designs may have the rules on dose adjustments (escalation or reduction) according to the adverse reactions or in order to achieve the pre-determined efficacy. The rationality of the relevant rules will be evaluated.

 

(中文版)

 


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