Phoenix – Certara

SOT Annual Meeting and ToxExpo

0 comments. Click here to read/write comments.

Topics:

ASCEPT Annual Scientific Meeting

0 comments. Click here to read/write comments.

Topics:

FDA Renews and Expands Its Use of Certara Software to Facilitate New Drug and Biologics Regulatory Review

PRINCETON, NJ – Oct. 9, 2018 – Certara today announced that the US Food and Drug Administration (FDA) has renewed, and in many cases increased, its number of Certara software licenses for reviewing new drug and biologics applications.

0 comments. Click here to read/write comments.

Topics:

Certara Trial Simulator v2.3: Powerful, Flexible, and Intuitive

Anticipate risks and preview the range of expected results before millions in R&D dollars are spent and human subjects are exposed to experimental therapies.

0 comments. Click here to read/write comments.

Topics:

Level C IVIVC: What Is It, and When Do You Use It?

Posted by Jean-Michel Cardot

on Aug 24, 2018 8:00:34 AM

In vitro in vivo correlation (IVIVC) links in vitro drug data to in vivo performance. Regarding in vivo performance, IVIVC can predict either the in vivo plasma time-concentration curve or in vivo pharmacokinetic (PK) parameters like Cmax and AUC. In this blog, I will discuss Level C IVIVC, and when you should use this approach. […]

2 responses. Click here to read/write comments.

Topics: PK/PD Modeling & Simulation

Certara Professional Certification Program

Certara Professional Certification is an online accreditation of user competency and proficiency in analysis of PK/PD data using Certara software.

0 comments. Click here to read/write comments.

Topics:

Certara Launches Version 8.1 of its Industry-leading Phoenix PK/PD Modeling and Simulation Software; Introduces Professional Certification Program

PRINCETON, NJ – June 5, 2018 – Certara today announced the launch of Phoenix 8.1.

0 comments. Click here to read/write comments.

Topics:

Accomplish More with Phoenix 8.1

The release of Phoenix 8.1 is arriving soon with new features that can simplify processes and can be automated to save you time.

0 comments. Click here to read/write comments.

Topics:

Making Sense of 6MWT Variability: Developing a Disease Progression Model for Duchenne Muscular Dystrophy

Watch this webinar with Drs. Lora Hamuro and Joga Gobburu to learn how they developed a natural history progression model for DMD using the 6MWT.

0 comments. Click here to read/write comments.

Topics:

Estimating the Number of Transit Compartments Using a Distributed Delay Model

Watch this webinar to learn how the delay operator implemented in Phoenix 8 can eliminate the need to add complex lines of code for each delay differential equation, simplify modeling delayed outcomes, and avoid inefficient workarounds and approximations.

0 comments. Click here to read/write comments.

Topics:

Reference-scaled Average Bioequivalence (RSABE) Approach for Drugs with a Narrow Therapeutic Index (NTID) Using Phoenix WinNonlin

0 comments. Click here to read/write comments.

Topics:

A Distributed Delay Approach for Modeling Delayed Outcomes in Pharmacokinetics and Pharmacodynamics Studies

0 comments. Click here to read/write comments.

Topics:

Implementation of Distributed Delays for Absorption Delays and Delayed Drug Response

0 comments. Click here to read/write comments.

Topics:

Certara Launches Version 8.0 of Industry-leading Phoenix PK/PD Modeling and Simulation Software

PRINCETON, NJ – October 3, 2017 – Certara today announced the launch of Phoenix 8.0. Phoenix is the most advanced, intuitive, and widely-used software for pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) modeling and simulation.

0 comments. Click here to read/write comments.

Topics:

Phoenix 8.0: Innovating in PK/PD Software—Streamlined. Robust. Trusted.

Phoenix 8.0 continues to set the gold standard in PK/PD software by delivering innovative features that streamline PK/PD analysis and outcomes, saving time, reducing errors, and providing regulatory agencies with more transparency into the analytical process.

0 comments. Click here to read/write comments.

Topics:

Phoenix 8.0 System Specification Sheet

The minimum and optimal recommended hardware requirements are shown in this document. Optimal hardware requirements are recommended for ideal application performance with
large datasets and projects.

0 comments. Click here to read/write comments.

Topics:

New FDA Commissioner Endorses Use of M&S to Advance Drug Development

Posted by Suzanne Minton

on Sep 1, 2017 8:42:54 AM

With the swearing in of Dr. Scott Gottlieb as Commissioner of Food and Drugs in May, many have wondered as to the climate he will set for the US FDA. Certara’s mission and business thesis aligns with the FDA’s July 7 announcement regarding the steps it is taking to implement the 21st Century Cures Act. […]

0 comments. Click here to read/write comments.

Topics: Clinical Transparency & Disclosure, Model-based Meta-analysis, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing

Use of Distributed Delay in PML

0 comments. Click here to read/write comments.

Topics:

Population Pharmacokinetic of L-DOPA and Its Main Metabolites: Use of the Phoenix-based QRPEM Algorithm

0 comments. Click here to read/write comments.

Topics:

Burstable Compute Grid

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.

0 comments. Click here to read/write comments.

Topics: