Minimal Residual Disease as an Early Endpoint for Accelerated Drug Approval in Myeloma: A Roadmap. [PDF]
Landgren O, Devlin SM.
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Critical insights into the evolving drug-approval process in China. [PDF]
Nikanjam M, Kurzrock R.
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Getting the Right Evidence After Drug Approval. [PDF]
Vreman RA, Leufkens HGM, Kesselheim AS.
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The evolutionary safety of mutagenic drugs should be assessed before drug approval. [PDF]
Lobinska G +4 more
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Targeted Therapies, Novel Antibodies, and Immunotherapies in Advanced Non-Small Cell Lung Cancer: Clinical Evidence and Drug Approval Patterns. [PDF]
Koban MU +6 more
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Making Drug Approval Decisions in the Face of Uncertainty: Cumulative Evidence versus Value of Information. [PDF]
Dijk SW +9 more
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Disease modification in osteoarthritis; pathways to drug approval. [PDF]
Katz JN +7 more
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How improvements in US FDA regulatory process and procedures led to the drug approval for first ever treatment of a common liver disease. [PDF]
Harvey BE.
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From Drug Discovery to Drug Approval: A Comprehensive Review of the Pharmacogenomics Status Quo with a Special Focus on Egypt. [PDF]
Elgarhy FM +7 more
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Clinical Trial Design and Drug Approval in Oncology: A Primer for the Advanced Practitioner in Oncology. [PDF]
Kurtin SE, Taher R.
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