Clinical Pharmacology Strategy

How to Plan and Implement a Pharmacology to Payer Framework

C. Kirkpatrick, C. Rayner

Pharmacology to the payer (P2P) is an innovative approach to create a framework for dialogue between drug sponsors, regulators, and payers. The core structure is the sequential linking of quantitative mathematical models—pharmacology, pharmacokinetics/pharmacodynamics (PK/PD), disease progression, epidemiology, health utilization, and health economics. In this blog post, we discuss how working with an amazing team of […]

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Topics: Clinical Pharmacology Strategy

Pharmacology to Payer: One Quantitative Drug Development Framework to Rule Them All

Craig Rayner

In JRR Tolkien’s Lord of the Rings, the power of the one ring forged by the evil sorcerer, Sauron, is used to control all of the disaggregated, independent kingdoms of Middle Earth. Similarly, but without the malice, the “pharmacology to the payer” (P2P) quantitative framework can be viewed as a way to unite and connect […]

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Topics: Clinical Pharmacology Strategy

Using PBPK Models to Optimize Anti-HIV Drug Dosing for Pregnant Women

In this webinar, we will discussed how we combined clinical and pre-clinical approaches to develop a PBPK model to predict the exposure of darunavir, a protease inhibitor commonly used to treat pregnant HIV+ patients. Moreover, we elaborated on the study design, data collection, and analyses that were used to investigate the clinical pharmacokinetics of antiretroviral agents during pregnancy.

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Expanding the Use of Pharmacometrics in Japan with Yusuke Tanigawara

Suzanne Minton

Science is a global endeavor. Indeed, one of the most exciting things about drug development is working with scientists doing important research all over the globe. The use of modeling and simulation (M&S) to support drug development has been embraced by pharmaceutical researchers in some parts of the world and is still gaining traction in […]

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Topics: PK/PD Modeling & Simulation

Quantify HBV Clinical Outcomes Database

The Quantify HBV Database is developed to document clinical safety and efficacy information on different nucleosides (eg, entecavir, lamivudine, tenofovir disoproxil fumarate, telbivudine, adefovir and combination) focusing on 3 different endpoints: HBV DNA time course, HBsAG time course, and HBeAG seroconversion that are available in the public domain.

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New Tools Support Developing Better TB Drugs

I. Gardner & O. Hatley

Tuberculosis (TB)—caused by infection with the mycobacterium Mycobacterium tuberculosis—is one of the top 10 leading causes of death worldwide with a total of 1.8 million people dying from the disease in 2015. TB is also the leading cause of death in HIV-infected individuals. TB usually attacks the lungs but can infect any part of the […]

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Topics: PBPK Modeling & Simulation

Certara’s Best of Blogs 2016

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

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