Phase I study design for non-cytotoxic agents [electronic resource] / Wendy Parulekar.
Material type:
FilmSeries: Henry Stewart talksBiomedical & life sciences collection. Cancer therapy : latest thinking in efficacy and toxicity: Publisher: London : Henry Stewart Talks, 2009Description: 1 online resource (1 streaming video file (40 min.) : color, sound)Subject(s): Antineoplastic Agents -- therapeutic use | Clinical Trials, Phase I as Topic | Neoplasms -- complications | Neoplasms -- drug therapy | Neoplasms -- therapyOnline resources: Click here to access online | Series Animated audio-visual presentation with synchronized narration.
Title from title frames.
Contents: Phase I study development: role in clinical drug development -- Terminology -- Phase I study objectives -- Preclinical data requirements -- Efficacy -- Target modulation -- Toxicity -- PK checklist -- Phase I study conduct -- Determination of the RPTD -- Cytotoxic agent -- Patient population -- Starting dose -- Dose escalation -- Dose escalation methods -- Phase I study design for non-cytotoxic agents -- Challenges for the evaluation of non-cytotoxic agents -- Two approaches to study phase I study design driven by target effects -- General considerations for RPTD determination -- Clinical trial sample analyses -- Examples: Cetuximab, Erlotinib, O6-Benzylguanine -- Phase I review -- Agents/targets -- Recommended phase II dose and primary basis.
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Mode of access: World Wide Web.