Month: January 2016
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
Rules for Submitting Electronic DMFs to FDA, Health Canada
Rumors of rules governing Drug Master File (DMF) submissions are swirling. I’ve heard a pair of questions lately. “Do I need to resubmit my DMF files in eCTD format?” “Should I resubmit my files electronically?” The answer depends on the agency. The U.S. FDA and Health Canada have each updated their submission requirements for … 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
Short Communication Tenofovir/Emtricitabine Metabolites and Endogenous Nucleotide Exposures are Associated with p16 INK4a Expression in Subjects on Combination Therapy
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