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Author: Jieun Choe

Model-Informed Precision Dosing: Background, Requirements, Validation, Implementation, and Forward Trajectory of Individualizing Drug Therapy

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Model-informed precision dosing (MIPD) has become synonymous with modern approaches for individualizing drug therapy, in which the characteristics of each patient are considered as opposed to applying a one-size-fits-all alternative. This review provides a brief account of the current knowledge, practices, and opinions on MIPD while defining an achievable vision for MIPD in clinical care … Continued

Certara Announces Confidential Submission of Draft Registration Statement for Proposed Initial Public Offering

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PRINCETON, N.J.—2020年10月8日. Certara, Inc., a global leader in biosimulation software and technology, today announced that it has confidentially submitted a draft registration statement on Form S-1 with the Securities and Exchange Commission (the “SEC”) relating to the proposed initial public offering of the company’s common stock. The number of shares to be offered … Continued

Enabling Warp Speed Using the Hypervelocity Innovation Model: A Blue Print for Drug Development in Pandemics

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Pharmaceutical R&D is organized around prioritized investments, delivering on assets with the greatest return of investments. Linear sequencing of trials and financial risks are determinants of speed in an enterprise. There is less flexibility in leveraging expertise around priorities that are thrust on the system by external forces. This commentary provides an insight into enabling … Continued

Certara Announces Appointment of President of its Software Division

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PRINCETON, N.J.—2020年9月17日. Certara, the global leader in biosimulation, today announced the appointment of Leif E. Pedersen as president of its software division, reporting to Chief Executive Officer William F. Feehery, PhD. Mr. Pedersen is a seasoned software industry executive with more than 25 years of experience across a range of software categories. He … Continued

Certara Announces Changes to its Board of Directors

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PRINCETON, N.J.—2020年9月1日.  Certara, the global leader in biosimulation, today announced changes to its board of directors, which took effect 2020年8月26日.  After successfully transitioning the leadership of Certara to Chief Executive Officer William Feehery, Edmundo Muniz has decided to step down from the board.  William Klitgaard, who has served on the board … Continued

Clinical trials of disease stages in COVID 19: complicated and often misinterpreted

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As of 2020年7月28日, 1840 clinical trials were registered globally, with 1001 clinical trials recruiting patients for COVID-19 management.1 Despite this large number, only 30 trials have been published as peer-reviewed or preprint publications.2 Media reports and prepublications on medRxiv and bioRxiv represent the most frequent mechanism for data sharing, with wide public reach and usually with little detail. However, … Continued

Accelerating Clinical Evaluation of Repurposed Combination Therapies for COVID-19

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As the global COVID-19 pandemic continues, unabated and clinical trials demonstrate limited effective pharmaceutical interventions, there is a pressing need to accelerate treatment evaluations. Among options for accelerated development is the evaluation of drug combinations in the absence of prior monotherapy data. This approach is appealing for a number of reasons. First, combining two or … Continued

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