Insights on Quantitative Systems Pharmacology with Piet van der Graaf

Quantitative systems pharmacology (QSP) is an emerging biosimulation technology that is going to increase pharmaceutical R&D productivity. This week at the Roundtable, we’re talking with Dr. Piet van der Graaf, PharmD, PhD about QSP and his vision for how it supports meeting the goal of precision medicine. Dr. van der Graaf is a professor of … Continued

Japan Workshop August 2016

This event runs from 1st – 5th August 2016 in Tokyo, Japan By participating in this workshop, you can learn how to predict the following items. Drug metabolic clearance (CL) Drug interactions was through the metabolism · (DDIs) The first pass in the gastrointestinal tract And absorption after oral administration (including the effects of diet … Continued

Immunotherapy in Oncology

One of the biggest recent advances in cancer therapy has been the arrival of novel immunotherapies, such as anti-PD1 antibodies, which have demonstrated remarkable efficacy in multiple tumor types. In many instances supported by the ‘Breakthrough’ status granted by the FDA, many pharmaceutical companies are making huge efforts to bring these promising treatments to cancer … Continued

Pharma Leaders in China Embrace Simcyp Science

Will the 21st century go down in history as the “Chinese Century”? If the status of its pharmaceutical industry is a barometer for China’s global position, then the answer may be “yes.” The size of the Chinese pharmaceutical market is second only to the US. In 2014, it was worth $105 billion. By 2020, the … Continued

7 Horrible Mistakes You’re Making with Your Drug Development Strategy

In thinking about the complex nature of drug development, I’m often reminded of a Dwight Eisenhower quote: “In preparing for battle, I’ve always found that plans are useless, but planning is essential,” Drug development is a risky business. According to a 2014 study from the Tufts Center for the Study of Drug Development, “the estimated … Continued

The Year in Review for Modeling and Simulation and Regulatory Writing

Happy New Year! 2015 was a year of huge growth—both personally and professionally—for our Certara® family. We’re so grateful for our clients who give us the privilege of supporting them in their work to bring safer and more effective treatments to patients. In this blog post, I’ll be looking back at the top 10 most popular … Continued

Hot Topic: Early Postpartum Treatment of Commercial Dairy Cows with Nonsteroidal Antiinflammatory Drugs Increases Whole-lactation Milk Yield

Previous research has shown that postpartum administration of the nonsteroidal antiinflammatory drug (NSAID) sodium salicylate can increase 305-d milk yield in older dairy cattle (parity 3 and greater). However, in this prior work, sodium salicylate was delivered to cows via the drinking water, a method that does not align well with current grouping strategies on … Continued

Altered Plasma Pharmacokinetics of Ceftiofur Hydrochloride in Cows Affected with Severe Clinical Mastitis

Mastitis is a frequent problem among dairy cows, reducing milk yield and increasing cull rates. Systemic therapy with the cephalosporin antimicrobial ceftiofur hydrochloride (CEF) may improve therapeutic outcomes, but the incidence of CEF violative residues has increased annually since 2011. One potential explanation is that disease status may alter the pharmacokinetics (PK) of CEF. To … Continued