Development of a cancer drug [electronic resource] / Martin Edelman.
Material type:
FilmSeries: Henry Stewart talksBiomedical & life sciences collection. Cancer therapy : latest thinking in efficacy and toxicity: Publisher: London : Henry Stewart Talks, 2022Description: 1 online resource (1 streaming video file (46 min.) : color, sound)Subject(s): United States Food and Drug Administration | Antineoplastic agents -- Development | Cancer -- Chemotherapy | Clinical trials -- Methodology | Drug approval -- Law and legislation | Drug development | Antineoplastic Agents -- pharmacology | Clinical Trials as Topic -- legislation & jurisprudence | Clinical Trials as Topic -- methods | Drug Approval -- legislation & jurisprudence | Neoplasms -- drug therapy | Pharmaceutical Preparations | United States Food and Drug AdministrationOnline resources: Click here to access online | Series 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.
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Mode of access: World Wide Web.