PRINCETON, NJ – May 31, 2017 – Certara today announced that it is partnering with Phase I Unit, Peking Union Medical College (PUMC) Hospital’s Clinical Pharmacology Research Center (PUMCH-CPRC) in Beijing to help Chinese pharmaceutical companies enhance their drug development processes.
Month: May 2017
Physiologically-based Pharmacokinetic (PBPK) models describe and predict the handling of drugs by the body in a realistic way based on demography, physiology, biochemistry, and genetics. We integrate this information with in vitro drug absorption, metabolism, and transport data to simulate and predict in vivo pharmacokinetics in virtual patient populations.
Do you get anxious about taking tests? Many people do because they want to show their best efforts. Submitting your New Drug Application (NDA) to the FDA can be thought of as the ultimate test of a drug program. Are you confident that you’ll have robust answers to the 40 different questions that the agency … Continued
In this webinar, Tatyana Wanderer and Behtash Bahador provided insights and recommendations gained from working with leading sponsors on portfolio-wide implementation and pilot programs to create plain language summaries of clinical trial results.
The problem of supersaturating drug products might loosely be summed up as: “If you’re not part of the solution, you’re part of the precipitate!” Indeed, more than 60% of new drug candidates are poorly soluble1 which can severely limit their bioavailability. To ameliorate this issue, a common approach is formulating to create supersaturated solutions of … Continued
PRINCETON, NJ – May 15, 2017 – Certara today announced that it has appointed Sandy Allerheiligen, PhD, to the newly-created role of Senior Vice President of Health Economics and Education.
As a veterinarian, I’m responsible for the health and welfare of my animal patients. Sometimes, drugs are used to treat animals that are being raised for food (e.g., meat and milk). Therefore, tissue residues are a unique concern in veterinary medicine because indirect exposure to drugs and their metabolites through eating meat or milk could … Continued
Certara’s Compute Grid allows you to access up to 1,800 cores in the cloud with just one click, significantly accelerating model runs. Projects that took days can now be completed in hours or even minutes, affordably and without IT support.
Data heterogeneity is a regulatory reviewer’s nightmare. Some sponsors talk about patient “gender” whereas others list the patient’s “sex.” What about date formats? Do you use the American-style month-day-year format or the European-style day-month-year? Inconsistent data presentation makes both collaborating on drug development projects and reviewing regulatory submissions more difficult. To address this challenge, the … Continued