This is the second of three blog posts discussing best practices for developing oligonucleotide therapeutics. The first blog in the series explained how these therapies work. Characterizing the pharmacokinetics (PK) of an investigational oligonucleotide drug is an important part of its pre-clinical development program as well as informing its later clinical development. In this blog, … Continued
The PMDA enters 8th consecutive year of using Certara’s biosimulation software PRINCETON, N.J.—2021年6月23日. Certara, a global leader in biosimulation, today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has renewed its licenses of Certara’s Simcyp™ and Phoenix™ biosimulation software. The PMDA has been using Certara’s biosimulation software since 2014. The Simcyp … Continued
By William Feehery In response to Covid-19, the global drug development community has moved faster and further than ever before. But what have we learned from meeting this emergency? Players throughout (…)
This fourth webinar in the “Let’s Talk MPTs” learning series will provide MPT product developers and other stakeholders an overview of clinical development and regulatory considerations when developing products that combine one or more active pharmaceutical ingredients (APIs) into an MPT product. Speakers • Deven Shah – Chemistry, Manufacturing, & Control (CM&C) Lead at Certara• … Continued
米国国立糖尿病・消化器・腎臓病研究所は、非アルコール性脂肪性肝疾患（NAFLD）を肝臓に過剰な脂肪が蓄積された状態とみなし、非アルコール性脂肪性肝炎（NASH）をNAFLDの一種としています。肥満と 2 型糖尿病はNAFLD発症のリスクが高いようです。Many innovative and scientifically intriguing … Continued
The pharmaceutical has made massive investments in complex biologics, a drug class that includes oligonucleotide therapeutics, immuno-oncology therapies, vaccines, antibody-drug conjugates, bispecific antibodies, and cell and gene therapies. These drugs can be challenging to develop for multiple reasons. Certara provides strategic approaches needed to optimize dosing, trial designs, payer plans, and regulatory strategy.
Use of clinical pharmacology and pharmacometrics approaches has become the gold standard for informing optimal dosing of investigational drugs in various patient populations. At the same time, the demand for clinical pharmacologists and pharmacometricians is outstripping the current supply of practitioners as well as the number of students being trained in these disciplines in North … Continued
Ever wondered what a career as a drug development consultant is like? In this session, Suzanne Minton, PhD, Director of Content Strategy interviewed Mark Lovern, PhD, Senior Vice President of Quantitative Science Services at Certara. Mark provided an overview of the software and services that Certara supports and discussed what it’s like to work as … Continued
