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Now showing items 101-110 of 144
Improving the efficiency of the later stages of the drug development process : survey results from the industry, academia, and the FDA
(Massachusetts Institute of Technology, 2004)
Drug development in the United States is a lengthy and expensive endeavor. It is estimated that average development times range from eleven to fifteen years and exceed costs of one billion dollars. The development pathway ...
The accelerated approval process in oncology : an examination of the conversion rate of approved therapies to full approval
(Massachusetts Institute of Technology, 2006)
In 1992, Accelerated Approval, or Subpart H approval, was added to the NDA regulations so promising products that provide a meaningful therapeutic benefit for serious or life-threatening diseases could be introduced to the ...
Development of statistical methodologies and risk models to perform real-time safety monitoring in interventional cardiology
(Massachusetts Institute of Technology, 2006)
Post-marketing surveillance of medical pharmaceuticals and devices has received a great deal of media, legislative, and academic attention in the last decade. Among medical devices, these have largely been due to a small ...
Proteomics for cancer biomarker discovery
(Massachusetts Institute of Technology, 2007)
Background: If we are to successfully treat cancer, we must understand the biologic underpinnings in conjunction with early diagnosis. Genome-wide expression studies have advanced the research of many cancers. Nevertheless, ...
Testimonials versus informational persuasive messages : the moderating effect of delivery mode and personal involvement
(Massachusetts Institute of Technology, 2008)
Health communications use factual information or/and personal testimonials to inform and influence individual decisions that enhance health. Increasingly, Web and other computer-based systems are being used to communicate ...
Applying axiomatic design methodology to enable adaptation of clinical guidelines to local contexts
(Massachusetts Institute of Technology, 2004)
Background: Local adaptation of guidelines may increase compliance with guidelines that have been developed at a national level and are often not used in practice because of contextual factors. We have developed a ...
An investigation of alliances between western life-science therapeutic and Indian firms
(Massachusetts Institute of Technology, 2008)
Large pharmaceutical companies (Multinational Pharmaceutical Companies or MPCs) have struggled in recent years with the rapidly accelerating costs of drug-discovery research and development. These costs continue to rise ...
Mergers and acquisitions in the medical device industry
(Massachusetts Institute of Technology, 2007)
Mergers and acquisitions in the Medical Device Industry are the primary mode of exit for early stage companies. The focus of this thesis is to examine factors which influence the value of these M&A transactions from the ...
A novel polymeric microelectrode array for highly parallel, long-term neuronal culture and stimulation
(Massachusetts Institute of Technology, 2008)
Cell-based high-throughput screening is emerging as a disruptive technology in drug discovery; however, massively parallel electrical assaying of neurons and cardiomyocites has until now been prohibitively expensive. To ...
Trends in U.S. regulatory approvals of the biopharmaceutical therapeutic entities
(Massachusetts Institute of Technology, 2005)
Pharmaceutical productivity, as measured by annual output of new molecular entities and new therapeutic biologics, has fallen significantly since reaching a peak in 1996. According to Food and Drug Administration (FDA) ...