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Big data in drug safetySafety and efficacy information on drugs shall be communicated to all stakeholders, including physicians, patients, insurers and investors, in a format that allows objective assessment of real value of the intervention compared to other treatments.... |
ARETE-ZOE, LLC Presenter: Veronika Valdova |
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Case Study: The Discovery of Telaprevir (VX-950, Incivek) for the treatment of Hepatitis CThis Case study shows the drug discovery process of Telaprevir for Hepatitis. IT discusses the background of Hepatitis, and the basic information on Hepatitis C, Preclinical studies, Clinical studies, critical findings, timeline to approval and the... |
Brain Science Institute NeuroTranslational Drug Discovery Program Johns Hopkins University Presenter: Dana Ferraris, Ph.D., M.B.A. |
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First-In-Man - risk assessmentThe example of TeGenero first-in-man case study was used to explore the usability of systems theoretic accident modeling and processes (STAMP) to create control structure of selected critical points in drug development, approval and... |
ARETE-ZOE, LLC Presenter: Veronika Valdova |
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Global Pharma Primer, Syllabus and Road MapThe material included in these modules serves many interests by facilitating understanding of construct, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and... |
ARETE-ZOE, LLC Presenter: ARETE-ZOE |
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IND-Enabling Studies and Preparation of the IND |