by Health Economics Research Group, Brunel University in Uxbridge .
Written in English
|Series||HERG research report -- no.15|
|Contributions||Brunel University. Health Economics Research Group., Great Britain. Department of Health. Research and Development Division.|
|The Physical Object|
|Number of Pages||129|
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A proof-of-concept study should be included in Phase II if it has not already been done during the MAD-study in Phase I. In addition, a treatment study with several different doses of the compound in comparison with a placebo and/or an active comparator over a treatment duration of 12 to 16 weeks is usually an essential part of the Phase II. At end of Phase II meeting, FDA questioned about dose We designed the third dose finding study to look at doses mg, 10 mg and 40 mg. 5/5/ 23 45 DRUG A - STUDY 0 Placebo mg 10 mg 40 mg Series1 46 DRUG A Redesigned Phase III studies with 20 mg and 40 mg. Books at Amazon. The Books homepage helps you explore Earth's Biggest Bookstore without ever leaving the comfort of your couch. Here you'll find current best sellers in books, new releases in books, deals in books, Kindle eBooks, Audible audiobooks, and so much more. Design of phase II cancer trials using a continuous endpoint of change in tumor size: application to a study of sorafenib and erlotinib in non small-cell lung cancer. J Natl Cancer Inst. ; – Lee JJ, Feng L. Randomized phase II designs in cancer clinical trials: current status and future directions. J Clin Oncol.