Drug Formulation

Phoenix

Phoenix PK/PD Modeling and Simulation Software Certara’s Phoenix® platform is the leading PK/PD modeling and simulation software used worldwide by more than 6,000 researchers at biopharmaceutical companies, academic institutions, and global regulatory agencies, including eleven divisions of the US FDA. Phoenix includes WinNonlin™, the industry standard for non-compartmental analysis (NCA), pharmacokinetic/pharmacodynamic (PK/PD), and toxicokinetic […]

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Phoenix 8.1 DEV

Phoenix PK/PD Modeling and Simulation Software Certara’s Phoenix platform is the leading PK/PD modeling and simulation software used worldwide by 6,000 researchers at biopharmaceutical companies, academic institutions, and global regulatory agencies, including eleven divisions of the US FDA. Phoenix extends the winning formula of WinNonlin by combining its trusted algorithms with built-in, easy-to-use graphical user […]

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A Practical Approach to the Challenges of Pediatric Drug Development

Posted by Barry Mangum

on Nov 17, 2017 8:00:05 AM

Drug developers can’t take an adult clinical trial protocol and simply retool it for pediatrics. Yet, in my work at a pediatric clinical research organization (CRO), I frequently see sponsors attempt to do just that. Successfully implementing a pediatric drug development plan poses challenges regarding trial planning, design, and conduct. In this blog post, I’ll […]

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Topics: Clinical Pharmacology Strategy, PK/PD Modeling & Simulation

Phoenix 8.1

Phoenix PK/PD Modeling and Simulation Software Certara’s Phoenix platform is the leading PK/PD modeling and simulation software used worldwide by 6,000 researchers at biopharmaceutical companies, academic institutions, and global regulatory agencies, including eleven divisions of the US FDA. Phoenix extends the winning formula of WinNonlin by combining its trusted algorithms with built-in, easy-to-use graphical user […]

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Due Diligence/Asset Evaluation

Inform Go/No Go Drug Investment Decisions with Scientific Due Diligence/Asset Evaluation Partnering with emerging biopharma companies and acquiring drug product candidates is an essential part of the pharmaceutical business ecosystem. Emerging companies are focused on drug discovery and early development. They often lack the funding or experience to manage the complex, expensive, and time-consuming path […]

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Modeling & Simulation for Drug Development & Formulation

A look at how to leverage modeling and simulation technology to enhance all phases of the drug development process.

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IVIVC Toolkit

Phoenix IVIVC Toolkit The Gold Standard for Predicting Pharmacokinetic (PK) Parameters from In Vitro Dissolution Data in Drug Development and Formulations. The Phoenix® IVIVC Toolkit™ creates and substantiates the Level A correlation as outlined in the FDA Guidance for Industry1 to correlate the in vitro dissolution profile of a dosage form with the in vivo pharmacokinetic (PK) […]

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PK/PD Modeling and Simulation

Phoenix: The Most Comprehensive and Widely-used Software for Pharmacokinetic (PK), Pharmacodynamic (PD), and Toxicokinetic (TK) Modeling and Simulation Phoenix®, the industry’s premier PK/PD modeling and simulation software workbench, is used by over 6,000 scientists in 60 countries at nearly 2,000 institutions, including the top 50 global pharmaceutical companies, academic institutes, and research foundations. Regulatory agencies, including 11 divisions […]

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