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Book Cover
Streaming video
Author Parulekar, Wendy, speaker

Title Phase I study design for non-cytotoxic agents / Wendy Parulekar
Published London : Henry Stewart Talks, 2009
Online access available from:
HSTalks Biomedical & Life Sciences Collection    View Resource Record  


Description 1 online resource (1 streaming video file (40 min.) : color, sound)
Series 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
Contents 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
Notes Animated audio-visual presentation with synchronized narration
Title from title frames
Mode of access: World Wide Web
System requirements: Browser compatibility: updated Mozilla Firefox, Google Chrome, Safari or Internet Explorer 8+. Browser settings: enable JavaScript, enable cookies from the Henry Stewart Talks site. Required Desktop Browser plugins & viewers: Updated Adobe Flash Player & Adobe Acrobat Reader. Mobile device & operating system versions: Android v4.0+, iPhone 4+ (iOS v6.x+), iPad 2+ (iOS v6.x+), BlackBerry OS v7.0+, Windows Phone v6.5.1+
Subject Antineoplastic Agents -- therapeutic use.
Clinical Trials, Phase I as Topic.
Neoplasms -- complications.
Neoplasms -- drug therapy.
Neoplasms -- therapy.
Genre/Form Video recordings.
Form Streaming video