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Monthly Archives: May 2010
An FDA Perspective on Risk/Benefit
If a man is alive, there is always danger that he may die, though the danger must be allowed to be less in proportion as he is dead-and-alive to begin with. A man sits as many risks as he runs. … Continue reading
What everyone should know about responding to Warning Letters.
It takes less time to do something right than it takes to explain why you did it wrong. -Lee’s Law Interestingly enough, many people do not take advantage of the Warning Letters posted on the FDA website. Personally, I always … Continue reading
Optimizing Drug Development and Preclinical Considerations for Oncology Indications
The Montgomery County (Maryland) Department of Economic Development will be hosting its next lunch meeting on Thursday, 27 May 2010 at the Shady Grove Innovation Center. The topic of the meeting will be, “Optimizing Drug Development and Preclinical Considerations for … Continue reading
Posted in Conferences and Meetings
Tagged animal studies, anticancer, drug development, FDA, oncology, preclinical
1 Comment
When Should You Write your Statistical Analysis Plans?
Recently in the LinkedIn Biostatistics group, one user asked: A client wants me to prepare final SAP [statistical analysis plan] shortly after protocol and CRFs are finalized for a Phase 3 trial, to submit to FDA prior to start of … Continue reading
Posted in Clinical Trials, Statistics
Tagged biostatistics, case report form, CRF, enrollment, FDA, LinkedIn, methodology, Phase 3, protocol, SAP, statistical analysis
1 Comment
LIPID MAPS 2010 Annual Meeting
The LIPID Metabolites and Pathway Strategy (MAPS) Annual Meeting was held at UCSD in La Jolla, CA from03-04 May 2010. LIPID MAPS was created in 2003 as a multidisciplinary effort to identify and quantitate all of the major (and some … Continue reading
Posted in Conferences and Meetings
Tagged Alzheimer’s, arthritis, atherosclerosis, cancer, diabetes, Duke, glucose, inflammation, inflammatory, insulin, lipid, LIPID MAPS, macrophages, Nobel Prize, obesity, stroke, UCSD, UNC, Vanderbilt
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