PBPK Modeling & Simulation

Precision Dosing Using PBPK Modeling

Devendra Pade

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 […]

Read More
Topics: PBPK Modeling & Simulation

How to Navigate “EMA Policy 70: Publication of Clinical Data” and Ensure Compliance

Nirpal Virdee

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. […]

Read More
Topics: Clinical Transparency & Disclosure

Get Ready for CDISC-SEND!

Maria Saluta

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 […]

Read More
Topics: PK/PD Modeling & Simulation

Reference-scaled Average Bioequivalence

Ana Henry

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 […]

Read More
Topics: PK/PD Modeling & Simulation

Automated Prediction of First-in-man Dosing Using Pre-clinical PK Data

Serge Guzy

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 […]

Read More
Topics: PK/PD Modeling & Simulation

How Biosimulation Can Provide Insight into Herbal Supplement Safety

Ellen Leinfuss

According to the Council for Responsible Nutrition, a trade group for the $32 billion nutritional supplement industry, 68% of adults take dietary supplements. Further analysis shows that supplement use is more prevalent among women, the children of women that take supplements, and the elderly. Like drugs, supplements do not work the same in all patients […]

Read More
Topics: PBPK Modeling & Simulation

Educating the World in Biosimulation: Creating Certara University

Frank Garafalo

“Fundamentally, Certara is a collection of academic discoveries and scientific minds who are charged with transforming patient care and improving the most crucial research and development and regulatory decisions. Our training organization and methodology must be equally accountable for this mission.” – Edmundo Muniz I heard these inspiring words from our CEO during my first […]

Read More
Topics: PK/PD Modeling & Simulation
Learn More LinkedIn Twitter Facebook Email