Clinical Pharmacology Strategy

A Practical Approach to the Challenges of Pediatric Drug Development

Barry Mangum

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 8.0

Phoenix PK/PD Modeling and Simulation Software Phoenix extends the winning formula of WinNonlin by combining its trusted algorithms with an easy-to-use graphical user interface and the additional tools needed to support more advanced analysis, such as population PK/PD modeling with Phoenix NLME and in vitro-in vivo correlation with the IVIVC Toolkit. The Phoenix Workbench leverages […]

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Certara Due Diligence/Asset Evaluation

Integrated Asset Evaluation for Go/No Go Drug Investment Decisions Partnering and acquisition of drug product candidates is an essential part of the pharmaceutical business ecosystem. While emerging companies are focused on drug discovery and early development, they often do not have the funding or experience to manage the complex, expensive, and time consuming path to […]

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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 Advanced, Intuitive, 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. Regulatory agencies, including 11 divisions of the US […]

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