Month: May 2016
Certara and The University of Manchester Co-host Inaugural Model-based Personalized Drug Dosing in Healthcare Conference
PRINCETON, NJ – May 25, 2016 – Clinical healthcare researchers, academic, and industry experts from eight countries collaborate to advance the goal of identifying the right drug dose for each patient.
Precision Dosing Using PBPK Modeling
With the discovery of newer drugs, the “one-size-fits-all” approach towards therapy is becoming a thing of the past. The new paradigm of precision medicine aims at delivering the right treatment at the right time to the right patients. An integral part of precision medicine is administration of a precise dose, which is a critical step … Continued
How to Navigate “EMA Policy 70: Publication of Clinical Data” and Ensure Compliance
The issue of transparency and disclosure of clinical trial data has been growing over the past few years. Clinical trials are essential in offering new therapies to patients. However, individuals participating in these trials put themselves at risk, and therefore, the medical community is obligated to derive as much benefit from that risk as possible. … Continued
Getting at the HAART of Precision Dosing: Using PBPK Models to Optimize Dosing of an Antiviral
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used as part of highly active antiretroviral therapy (HAART) for the treatment of a human immunodeficiency virus (HIV) type 1. It is primarily metabolized by CY2B6. A standard dose of efavirenz has been associated with serious adverse reactions in poor metabolizers (PMs) of CYP2B6, necessitating a reduction … Continued
The Evolving Landscape of Drug Development in China
Pharma innovation will continue to increase in China as product differentiation grows in importance. As a result, the percent of generics on the Chinese market will continue to decrease and the number of novel new drug applications will increase.
Get Ready for CDISC-SEND!
Towards the end of 2016, the US Food and Drug Administration (FDA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA), will require electronic submissions of certain nonclinical data using the CDISC SEND standard format. Other regulatory agencies, including the European Medical Agency (EMA), Korean Ministry of Food and Drug Safety, and China Food and … Continued
Reference-scaled Average Bioequivalence
The standard approach for approval of generic drugs is to run a bioequivalence study to demonstrate that a generic product is comparable to an approved (ie, reference) drug in their rate and extent of absorption. The rate and extent of drug absorption are determined from the pharmacokinetic parameters: peak concentration (Cmax) and the area under … Continued
Dr. Adam Darwich is Appointed Certara Lecturer in Precision Dosing at The University of Manchester, England
PRINCETON, NJ – May 12, 2016 – This new role for Adam Darwich, PhD, furthers Certara’s mission to bring individual patient dosing into mainstream clinical care.
Automated Prediction of First-in-man Dosing Using Pre-clinical PK Data
If ever there was a cautionary tale illustrating the importance of getting allometric scaling of drugs right, it’s the story of Tusko the elephant. In 1962, Tusko was living at the Lincoln Park Zoo in Oklahoma City where he received a dose of the psychomimetic drug, lysergic acid diethylamide, better known as LSD. The dose … Continued