Edelman, Martin,
Development of a cancer drug [electronic resource] / Martin Edelman. - London : Henry Stewart Talks, 2022. - 1 online resource (1 streaming video file (46 min.) : color, sound). - Cancer therapy : latest thinking in efficacy and toxicity, 2056-452X . - Henry Stewart talks. Biomedical & life sciences collection. Cancer therapy : latest thinking in efficacy and toxicity. .
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.
Mode of access: World Wide Web.
5766 Henry Stewart Talks
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 Administration.
Development of a cancer drug [electronic resource] / Martin Edelman. - London : Henry Stewart Talks, 2022. - 1 online resource (1 streaming video file (46 min.) : color, sound). - Cancer therapy : latest thinking in efficacy and toxicity, 2056-452X . - Henry Stewart talks. Biomedical & life sciences collection. Cancer therapy : latest thinking in efficacy and toxicity. .
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.
Mode of access: World Wide Web.
5766 Henry Stewart Talks
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 Administration.