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Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

Unknown author(s)

Biotechnology Law Report · 2007 · 198 citations · 1 references

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Concepts

MedicineOncologyPharmacologyClinical PharmacologyDrug Approval ProcessesPrecision OncologyClinical Trial Approval ProcessesClinical Trial DesignClinical Trial PhasesClinical TrialsClinical Trials In OncologyDrug ApprovalClinical Endpoints CorrelationClinical Protocol DesignClinical Trial Efficacy EndpointsMarket Authorization ProcessesRegulatory Approval Pathways

References

1

New Guidelines to Evaluate the Response to Treatment in Solid Tumors

Patrick Therasse, Susan G. Arbuck, Elizabeth A. Eisenhauer et al. · JNCI Journal of the National Cancer Institute · 2000 · 15.7K citations

Medicine, Oncology, Cancer Pharmacology +12