Automated Average Bioequivalence Analysis with Additional Metrics and Statistics to Meet the FDA Guidance on Methylphenidate Hydrochloride Using Phoenix WinNonlin
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Tag: Phoenix
Answers to Your Burning Questions on Level C IVIVC
In vitro-in vivo correlation (IVIVC) technology allows formulation and manufacturing (CMC) professionals to understand how dissolution parameters affect in vivo drug performance. IVIVC can be performed at one of three levels—A, B, and C. Getting the most out of this tool requires knowing when and how to use which level of IVIVC. Here are some […]
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PK/PD Modeling & SimulationSOT Annual Meeting and ToxExpo
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ASCEPT Annual Scientific Meeting
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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.
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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.
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Level C IVIVC: What Is It, and When Do You Use It?
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. […]
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PK/PD Modeling & SimulationCertara Professional Certification Program
Certara Professional Certification is an online accreditation of user competency and proficiency in analysis of PK/PD data using Certara software.
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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.
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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.
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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.
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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.
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Reference-scaled Average Bioequivalence (RSABE) Approach for Drugs with a Narrow Therapeutic Index (NTID) Using Phoenix WinNonlin
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A Distributed Delay Approach for Modeling Delayed Outcomes in Pharmacokinetics and Pharmacodynamics Studies
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Implementation of Distributed Delays for Absorption Delays and Delayed Drug Response
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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.
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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.
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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.
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New FDA Commissioner Endorses Use of M&S to Advance Drug Development
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. […]
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Clinical Transparency & Disclosure, Model-based Meta-analysis, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical WritingUse of Distributed Delay in PML
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