1. Development of New Medicines: From Pre-Clinical Research to Marketplace


    from BioXpertz / Added

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    http://bit.ly/1GTYKkp Course Description This course covers the non clinical and clinical areas of research required to a bring a new drug to market. You will get a understanding of key topics such as drug discovery and target selection, pharmacokinetics, including drug metabolism, toxicology and drug safety, and the objectives and structure of human clinical trials. will be explored. Data resulting from these areas of research provide key information to the U.S. Food and Drug Administration (FDA) on the safety and effectiveness of an investigational drug. During the course, you will also understand the IND and NDA / BLA applications, drug patents, FDA processes and regulations, as well as the roles and mechanisms underlying the conduct of clinical trials. Upon completion of the course, the student should understand and appreciate: -Key activities related to the preclinical development of investigational drugs; -The different phases and processes related to the clinical evaluation of investigational drugs in humans; -How biopharmaceutical companies make decisions to advance or halt the development of new drugs; -The role of the FDA in the evaluation of investigational drugs, and -The challenges and complexities that biopharmaceutical companies face in the development of new drugs. Target Audience This course is targeted for individuals who seek to understand the key non clinical and clinical activities in the development of new drug entities. Therefore, the content of the course would be relevant for those currently working in the biopharmaceutical industry who are not aware of the total activities and requirements involved in new drug development. The course also provides relevant information on drug development processes to those seeking careers in the biopharmaceutical industry.

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    • Medpace Clinical Pharmacology - Volunteers


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      What to expect when you volunteer for a study at Medpace Clinical Pharmacology Unit (MCPU) in Madisonville, Ohio

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      • 2014-08-28 11.01 Removing References to E1527-05: Are you ready?


        from GeoSearch / Added

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        By now, all consultants using the ASTM standard for conducting Phase I ESAs should be using the ASTM E1527-13. The EPA reference to E1527-05 will likely come to an end shortly. Julie Kilgore, chair of the ASTM E1527-13 task force, and Patricia Overmeyer, Land Revitalization Coordinator with the EPA Office of Brownfields, discussed the timeframe for removing the reference to E1527-05, present updated case studies regarding the application of new and revised ASTM E1527-13 terms, and answered questions about implementing the new standard.

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        • Réservoir // Phase I


          from Alexis Zeville / Added

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          Videographer // Alexis Zeville www.alexiszeville.com Music // Réservoir Phase I http://reservoir6b.bandcamp.com/album/vhs-1 Filmed respectively throughout the brutalist architecture of the Portage complex in Hull QC where all the field recordings we're taken to create the four permutations of Réservoir's album.

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          • Medpace Clinical Pharmacology Unit


            from Medpace CRO / Added

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            Comprehensive Phase I services As a full-service CRO, Medpace offers a suite of Phase I services through its CPU, Bioanalytical lab, consulting, and regulatory capabilities. Medpace's investment in early phase research involves cutting edge technology, instrumentation, and process, developed by 20 years in clinical research, led by therapeutic experts.

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            • Vapor Intrusion and Vapor Encroachment Emerging Requirements (07/2013)


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              240 Plays / / 0 Comments

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              • DiMatteo Nutritional Guideline Series Phase I - Protein


                from CrossFit OTG / Added

                32 Plays / / 0 Comments

                A brief, yet detailed description of Protein. I cover the what is, when to eat, why, how much and the sources.

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                • Facemask


                  from Alan Curtis / Added

                  394 Plays / / 0 Comments

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                  • Phase I operation


                    from Prosthesis: The Anti-Robot / Added

                    800 Plays / / 0 Comments

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