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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
Found In Microsite: News Magazine Dev
The final guidance will explain the issues generic applicants should consider when design differences between a generic version of a branded drug-device combination product could impact the clinical effect or safety profile of the generic product, FDA ...
Posted By Linda Brown
Found In Microsite: News Magazine Dev
December 13, 2017 The Food and Drug Administration (FDA) expects to break records in new drug and device approvals, the agency chief told the Senate health committee on Dec. 7. FDA is on pace to approve the highest number of novel medical devices in ...
Posted By Linda Brown
Found In Microsite: News Magazine Dev
“Almost everyone in the Senate wants to speed up our efforts in opioids, especially to find a nonaddictive pain medicine,” Sen. Lamar Alexander (R-Tenn.) said on Dec. 7. “And if giving him [NIH Director Francis S. Collins] more flexibility in how he spends ...
Posted By Linda Brown
Found In Microsite: News Magazine Dev
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
Found In Microsite: News Magazine Dev
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. ...