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Tag Archives: personalized medicine
Conference Recap – Biomarker World Congress 2011
Everywhere in the news today, we hear that we are in the era of personalized medicine – where new medicines will be tailor-made for individual patients. Specifically, personalized medicine is dedicated to the concept hat the right drug is … Continue reading
Posted in Clinical Trials, Conferences and Meetings
Tagged biomarkers, breast cancer, cancer, Chemotherapy, clinical trials, efficacy, oncology, personalized medicine, Phase 1, Phase 2, validation
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Biomarker Qualification and Validation: Where are We Now?
Personalized medicine. The pinnacle of healthcare where treatment for a patient’s disease is specifically tailored for his or her genetics and disease characteristics. As the era of blockbuster drugs is drawing to a close, the era of personalized medicines is … Continue reading
Posted in FDA, Industry News, Regulatory Strategy
Tagged biosimilar, clinical trials, drug development, FDA, guidance, personalized medicine
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Important Steps Forward for Early Detection and Diagnose of Alzheimer’s Disease
Image via Wikipedia In a recent report by Geert De Meyer of Ghent University in Belgium and colleagues, titled “Diagnosis-Independent Alzheimer Disease Biomarker Signature in Cognitively Normal Elderly People” (Arch Neurol. 2010;67(8):949-956) it was demonstrated that measuring certain proteins in … Continue reading
Posted in Clinical Trials, Conferences and Meetings, Industry News, Publications
Tagged Alzheimer’s Disease, BIO 2010, biomarker, clinical trials, drug development, personalized medicine
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Joint Statistical Meetings 2010 Retrospective: A CRO Statistician’s Perspective
Image via Wikipedia The Joint Statistical Meetings is often a good place to learn about emerging issues in the analysis of clinical trials (and all of the other fields that statistics touches, as a matter of fact). Here are just a … Continue reading
DIA 2010 – Week in Review
The DIA 2010 Annual Meeting was a great success and Washington, DC was a great location. In addition to the thousands of industry attendees, the location made it possible for this year’s meeting to include FDA representatives from all areas … Continue reading
Posted in Conferences and Meetings, eCTD, FDA
Tagged adverse events, biomarkers, biotech, cell therapy, clinical development, clinical trials, CMC, comparative effectiveness, data standards, DIA, eCTD, FDA, globalization, in vitro diagnostics, personalized medicine, pharmacokinetics, Phase 1, Phase 2, RPS, study tagging files, transparency
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