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Tag Archives: efficacy
Fifth China Medicinal Biotech Forum – Conference Recap
I recently returned from the Fifth China Medicinal Biotech Forum held in Beijing, China from 07-09 November 2011. The purpose of this conference was to update graduate students in China on the latest trends in biotechnology. This forum also allowed … Continue reading
Posted in Clinical Trials, Conferences and Meetings
Tagged biologics, biosimilar, biotech, China, clinical research, clinical trials, conference, DNA, efficacy, FDA, gene therapy, immuno, manufacturing, monoclonal antibody therapy, NIH, Phase 1, recombinant proteins, safety
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Project Management for Biotech Companies
In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success. Large organizations understand the value that project management can contribute to a successful project. The smaller companies tend to … Continue reading
Posted in Clinical Trials, Project Management, Regulatory Strategy
Tagged biotech, Cato Research, central labs, clinical investigator, clinical research, clinical trials, CMC, CROs, drug development, drug product, efficacy, enrollment, FDA, GCP, GLP, GMP, ICH, manufacturing, nonclinical research, project management, protocol, safety, site selection, SOP, stability, toxicology
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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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FDA Pediatric Study Information
The FDA’s Pediatric Drug Development page is a great place to find information on pediatric studies. FDA just posted the most recent metrics for studies performed between September 27, 2007 and September 30, 2010 related to the Best Pharmaceuticals for Children … Continue reading
Posted in Clinical Trials, FDA, Regulatory Strategy
Tagged clinical trials, drug development, efficacy, FDA, pediatric, safety, statistical analysis, vaccines
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Improving Assessment Data Consistency in Multi-Center Studies
Ensuring assessments are conducted, analyzed, and reported consistently across sites is a challenge facing managers of multi-center clinical studies. While identification and quantification of between site variation is typically part of the statistical analysis, collecting more consistent data from the … Continue reading
