PRINCETON, NJ – Feb. 15, 2017 – Certara today announced that Professor Piet van der Graaf, PharmD, PhD, its vice president of quantitative systems pharmacology, has been appointed a F1000Prime faculty member.
When your physician writes you a prescription, they do so knowing that the dose prescribed will (on average) be safe and beneficial to you, but that it is likely certainly not optimal for you as an individual (as has been the topic of a previous blog post). The balance between absorption, distribution and elimination of … Continued
Certara Strategic Consulting scientists used model-based meta-analysis (MBMA) to support developing a fixed-dose combination of ezetimibe and atorvastatin.
Certara Strategic Consulting scientists used model-based meta-analysis (MBMA) to support dose optimization and product positioning of a psoriasis drug.
Policy 0070― published by the European Medical Agency (EMA) in October 2014― has made the world of regulatory writing a more complicated place. The policy requires specified submission documents to be made public for all marketing authorization applications (MAA’s) submitted as of January 1, 2015 and for all indication extensions and line extensions submitted as … Continued
Editor’s Note: This is the first in a series of posts related to the Identification of Medicinal Products (IDMP) written by CAPT Vada A. Perkins (ret) that will appear on the eCTD Summit. Mr. Perkins is the Founder and Managing Principal of IDENTIFICA, a global life sciences consulting and IT firm specializing in global product … Continued
