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PBPK Modeling and Simulation:
Yesterday's Scientific Endeavor Is Today's Regulatory Necessity

Member Spotlight

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Advancing the Course of PK/PD Modeling

Throughout her career, Diane Mould has both advanced and spread the word on computer modeling. 

As a scientist, researcher, entrepreneur, and educator, Diane Mould, Ph.D., FCP, FAAPS, has demonstrated her multiple talents.

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eLearning

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FDA and EMA Issue Guidelines for PBPK Modeling

An AAPS webinar discusses regulations in the U.S. and Europe.

In recent years, regulators have observed a significant increase in the various ways drug companies are using physiologically based pharmacokinetic models in their pharmaceutical submissions.

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Pharmaceutical Science Update

Posted By Linda Brown
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Rep. Michael C. Burgess (R-Texas), chairman of the Energy and Commerce health subcommittee, and Rep. Diana DeGette (D-Colo.) made their remarks exactly one year after the House passed 21st Century Cures, a broad biomedical research bill to spur new drugs ...
Posted By Linda Brown
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December 6, 2017 House Tax Plan Could Drive Away Future Scientists, Groups Say The House Republican tax reform plan could discourage careers in science and stifle medical progress by making graduate school less affordable, according to science groups. ...
Posted By Linda Brown
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FDA investigators found violations of current good manufacturing practices (cGMPs) at Dae Young Foods Co. in Seoul, the agency said in a warning letter posted online on Nov. 28. Drug products made at the facility are considered adulterated under the Federal ...
Posted By Linda Brown
Found In Microsite: News Magazine Dev
December 6, 2017 Delayed FDA Guidance Clarifies Drug Product Identifier Policy Drug distributors and pharmacists finally have draft guidance from the Food and Drug Administration (FDA) on how to handle products that are already in the supply chain that ...
Posted By Matt Baughman
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Recently, drug makers have raised concerns about whether compounders are complying with applicable Food and Drug Administration (FDA) regulations and whether compounded drugs are safe and effective. Endo International Plc's subsidiaries Endo Par Innovation ...

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