Clinical Pharmacology Strategy

Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions

Maria Saluta

Analogous to how a geologist surveys the “lay of the land” to determine if oil lies underneath, or an investment advisor strives to understand the “lay of the land” to decide how to invest in a turbulent market, sponsors and regulators also need to determine how to best utilize and report modeling and simulation results […]

Read More
Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing, Regulatory Submissions Management

Ready, Set, Model! Take PK/PD Analysis to New Heights with Phoenix 8.0

Maria Saluta

Dr. Scott Gottlieb, the Commissioner of Food and Drugs, has outlined the steps the US FDA will take to implement the 21st Century Cures Act. In outlining the plan, the Commissioner endorses modeling and simulation approaches to increase the efficiency of drug development. Certara has launched Phoenix® 8.0, the latest version of the innovative PK/PD […]

Read More
Topics: PK/PD Modeling & Simulation

How Clinical Pharmacology Gap Analysis Can Create Value

Julie Bullock

During my years reviewing applications for the US FDA, I encountered a lot of poor planning concerning a drug’s clinical pharmacology program. This poor planning left the company either lacking data to make informed decisions or scrambling at the end of development to address unanswered issues. Early planning is key to regulatory success, not only […]

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

Using Model-based Meta-analysis to Inform Drug Development for Autoimmune Diseases

MBMA helps sponsors design less costly and more precise trials with an eye toward achieving commercial success for both the drug and portfolio. Watch this webinar with Dr. Mark Lovern, Vice President at Certara Strategic Consulting, to learn how leveraging public data can provide value by abbreviating the “cash spiral” inherent to proprietary data.

Read More
Topics:

Using Model-informed Drug Development Approaches to Accelerate Orphan Drug Development

Maria Saluta

Orphan drugs are used to treat rare diseases and disorders. This year marks the 35th anniversary of both the landmark Orphan Drug Act, a law passed by the US FDA that created legal and financial incentives for pharma and biotech to pursue rare disease R&D, and the formation of the National Organization for Rare Disorders […]

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

The Biggest Drug Development News Stories in 2017

Suzanne Minton

When I reflect on the state of drug development in 2017, the opening lines of Charles Dickens’ A Tale of Two Cities comes to mind. It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, […]

Read More
Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation

How to Perform Level C IVIVC in Phoenix

In this webinar, Professor Jean-Michel Cardot explained how to perform Level C IVIVC using Phoenix. Learn how to calculate pharmacokinetic parameters via the non-compartmental analysis module; how to calculate dissolution parameters via the dissolution module; how to link the in vivo pharmacokinetic parameters and in vitro dissolution parameters via the linear relationship module; and how to calculate dissolution limits.

Read More
Topics:

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 […]

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

Phoenix Modeling Language School: The Semester in Review

Maria Saluta

Phoenix® WinNonlin® uses Phoenix Modeling Language (PML) to encode pharmacokinetic (PK) and pharmacodynamic (PD) models. Although most models can be built using the Phoenix graphical user interface (GUI), some models require custom coding with PML. During the latter part of 2016, Certara’s support team, led by Dr. Bernd Wendt, Director of Training and Support, introduced […]

Read More
Topics: PK/PD Modeling & Simulation
Learn More LinkedIn Twitter Facebook Email