Month: April 2017
Predicting Drug Exposure During Pregnancy Using PBPK Models
Moms want the best for their kids even before they’re born. When I was pregnant with my son and daughter, I watched my diet and tried to stay active. During both of my pregnancies, I had to take medications several times. And I was always concerned about whether the medications could impact my unborn children. … Continued
Clinical Study Protocols: How to Write to Solve Problems Now and Avoid Big Ones in the Future
The identification of different responsibilities, under the clear leadership of the medical writer, is necessary to improve the quality of clinical study protocols – to prevent problems and mistakes that can result later, during conduct of the clinical trial, or afterwards, when reporting on trial results.
Modeling & Simulation for Drug Development & Formulation
A look at how to leverage modeling and simulation technology to enhance all phases of the drug development process.
Mechanistic Modeling of Genome Scale Molecular Interaction Networks
The scope of PBPK modeling can be expanded by assimilating mechanistic models of intracellular processes from the Systems Biology field. Genome scale metabolic networks (GSMNs) represent whole sets of metabolic enzymes expressed in human tissues. Dynamic models of the gene regulation of key drug metabolism enzymes are also available. Here, we introduce GSMNs and review ongoing work on integrating PBPK, GSMNs and metabolic gene regulation. We demonstrate example models.
How AI Tech Is Changing Regulatory Writing
Did you know that you’re likely using artificial intelligence (AI) in your everyday life? For example, the digital music service, Spotify, creates “mood-based” playlists that are curated to users’ musical preferences. Spotify generates these customized play lists using a machine learning algorithm that has learned your unique musical preferences based on your previous interactions with … Continued
Certara Introduces Comprehensive Solution to Prepare, Analyze and Submit Pharmacokinetic (PK) Data
PRINCETON, NJ – Apr. 19, 2017 – Certara today announced the launch of a new solution for preparing, analyzing and submitting PK data in Clinical Data Exchange Standards Consortium (CDISC) format. CDISC supports the acquisition, exchange, submission and archiving of non-clinical and clinical data.
Speaking into the Ether: Challenges of the Virtual Pharma Workplace
In this webinar, Drs. Peter Bonate and Stacey Tannenbaum discussed what kind of technology tools can facilitate a connection with your audience and address the difficulties of speaking into the ether. They offered practical solutions that you can use to strengthen your collaboration in the virtual workplace.
New Tools Support Developing Better TB Drugs
Tuberculosis (TB)—caused by infection with the mycobacterium Mycobacterium tuberculosis—is one of the top 10 leading causes of death worldwide with a total of 1.8 million people dying from the disease in 2015. TB is also the leading cause of death in HIV-infected individuals. TB usually attacks the lungs but can infect any part of the … Continued
Certara’s d3 Medicine Partners with the Australian Department of Defence
PRINCETON, NJ – Apr. 5. 2017 – Certara today announced that its d3 Medicine company has been selected to conduct a national audit of Australia’s medical countermeasures (MCM) product research and development (R&D) capabilities and capacity.