New clinical trials policy at FDA
Article Abstract:
The US Food and Drug Administration (FDA) encourages drug companies to design clinical trials with flexible enrolment, closing and other parameters, known as adaptive design, in a bid to speed drug development. The FDA deputy commissioner for medical and scientific affairs Scott-Gottlieb laid out the agency's plan to develop five guidance papers over the next five years at a July 2006 meeting in Washington, DC.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2006
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Performance comparison of one-color and two-color platforms within the MicroArray Quality Control (MAQC) project
Article Abstract:
A simultaneous comparison of results from one- and two-color labeling designs is provided through the use of two RNA samples from the MicroArray Quality Consortium (MAQC) project. It is concluded that data quality is equivalent between the two approaches and both provide similar levels of biological insight.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2006
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