Plan to Accelerate Your Time to Drug Submissions

Innumerable factors can come into play, but there are common themes driving how quickly you can get from your last database lock (DBL) to submission of your marketing application. Speaking from first-hand experience across >50 marketing submissions, we will demonstrate how, through thorough planning, you can improve and shorten your speed to submission. We will … Continued

A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development

Pediatric PBPK models have broad application in the drug development process and are being used increasingly to optimize and replace clinical studies.  However, the approach has yet to become fully integrated in regulatory submissions. Emerging data support an expanded integration of the PBPK model informed approach in regulatory guidances on pediatrics. Best practice standards are … Continued

Upcoming 2021 Certara University Express Webinars

Certara University is pleased to announce our complimentary 30-minute Express webinar series: Part 2: Introduction to RsNLME (R speaks NLME) and overview of expanded workflowDate/Time: May 12th, 2021 at 11:00 AM EST Description: This webinar is the second of a two-part RsNLME introduction series and will further review core functionality. RsNLME is a collection of R … Continued

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