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Far from being a single procedural step, a FIH trial is built on a broad body of scientific, regulatory and operational work designed to ensure that the transition from preclinical research to human investigation takes place within a rigorous framework focused on safety, quality and evidence generation
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doi: 10.1046/j.1439-0396.2003.00439.x Kacar C, Zonturlu AK, Karapehlivan M, Ari UC, Ogun M, Citil M
This genotype-dependent efficacy is robustly supported by epidemiological and clinical evidence in colorectal cancer, particularly for individuals with combined GSTM1 and GSTT1 null genotypes
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