June 17, 2021, Thu 11:15 AM EDT Learn about the role of clinical pharmacology and model-informed drug development in aiding the development and approval of drugs for rare and neglected diseases. Examples of applications of these principles to global health will also be presented.
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
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
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