TY - ADVS AU - Edelman,Martin TI - Development of a cancer drug T2 - Cancer therapy : latest thinking in efficacy and toxicity, PY - 2022/// CY - London PB - Henry Stewart Talks KW - United States KW - Food and Drug Administration KW - Antineoplastic agents KW - Development KW - Cancer KW - Chemotherapy KW - Clinical trials KW - Methodology KW - Drug approval KW - Law and legislation KW - Drug development KW - Antineoplastic Agents KW - pharmacology KW - Clinical Trials as Topic KW - legislation & jurisprudence KW - methods KW - Drug Approval KW - Neoplasms KW - drug therapy KW - Pharmaceutical Preparations KW - United States Food and Drug Administration N1 - Animated audio-visual presentation with synchronized narration; Title from title frames; Contents: Requirements for drug approval in the U.S. -- Legal evolution of drug approval -- The FDA and oncology drugs -- Clinical trial phases -- The effectiveness requirement -- Traditional and new approaches to trial design -- Types of controls -- Targeted therapies -- Companion diagnostics -- Endpoints for oncology trials -- Types of drug approval -- New drug application (NDA) -- Biomarkers -- FDA reviews and approvals; Access restricted to subscribers UR - https://hstalks.com/bs/4964/ UR - https://hstalks.com/bs/p/385/ ER -