Role of Phase 0 trials in drug development.
作者： James H Doroshow , Shivaani Kummar
DOI: 10.4155/FMC.09.117
关键词: Drug development 、 Intensive care medicine 、 Phase (combat) 、 Pharmacology 、 Therapeutic intent 、 Drug discovery 、 Proof of concept 、 Skepticism 、 Medicine 、 Ethical concerns
摘要: Phase 0 trials can provide proof of concept that an agent modulates its intended target without exposing patients to the drug-tolerability testing precedes efficacy evaluation. Drugs do not modulate their targets be discarded, focusing development resources on most clinically promising agents. However, wider uptake may hindered by ethical concerns over lack therapeutic intent, substantial required develop and validate assays or skepticism such save time.
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