Revolutionizing Drug Development— d3 Medicine Joins the Certara Family

Craig Rayner

Thinking Without BordersTM Developing Medicines that MatterTM These guiding principles fueled the creation of d3 Medicine. With a goal of revolutionizing the pharmaceutical paradigm to accelerate developing medicines that benefit society, combining d3 and Certara was a ‘no brainer.’ Delivering on our clients’ mission The d3 Medicine staff join Certara’s Strategic Consulting (CSC) division, which […]

Read More
Topics: Clinical Trial Design, Drug Safety, Model-based Drug Development, PBPK Modeling and Simulation, PK/PD Modeling and Simulation

The Ultimate Cheat Sheet on CDISC-SEND

Chris Lovejoy

On December 18, 2016, numerous regulatory agencies will require electronic submission of non-clinical data using CDISC’s standard format. What exactly are CDISC data standards and how will they impact drug developers? In this blog post, I will provide an overview of the CDISC SEND data standard, review some of the requirements for implementing SEND, and […]

Read More
Topics: Model-based Drug Development, PK/PD Modeling and Simulation

What’s New in Phoenix 7.0!

Maria Saluta

On September 14, Dr. Nathan Teuscher presented an informative webinar focused on new features and enhancements in Phoenix® 7.0, which was released on August 10. This blog post summarizes the topics discussed during the presentation. Nathan began his presentation with an overview of new features in Phoenix 7.0 including: A new graphics engine for high […]

Read More
Topics: PK/PD Modeling and Simulation

Quantitative Pharmacology Strategies for Pediatric Drug Development

Patrick Smith

Pediatric patients are not simply small adults. Children differ from adults in both disease pathophysiology and pharmacokinetics/pharmacodynamics (PK/PD). Yet historically, 80 percent of medicines used in children had little to no data guiding prescribers on proper use. In this blog post, I’ll discuss the challenges of developing drugs for children and explain how quantitative pharmacology […]

Read More
Topics: Clinical Trial Design, Drug Safety, Model-based Drug Development, PK/PD Modeling and Simulation

Arming Adherence-Based Drug Development with Pharmacometrics

Jonathan Knights

The time is right to explore how sensor-enabled digital adherence monitoring systems can benefit patients, sponsors, and payers. Non-adherence to prescribed medications is a key issue facing our healthcare industry, costing the US healthcare economy between $100-300 billion annually, representing between 3-10% of total healthcare costs [1, 2]. Further, non-adherence also decreases our ability to […]

Read More
Topics: Clinical Trial Design, Model-based Drug Development, PK/PD Modeling and Simulation

How to Expedite FDA Approvals of Orphan Drugs

Thomas Peyret

350 million patients worldwide suffer from 7,000 rare diseases, yet only 300 of these diseases have approved treatments. This gap, impacting 95% of rare disease patients, represents a huge unmet medical need. Developing drugs for rare diseases poses a range of clinical, regulatory and commercial challenges. The small number of patients are difficult to identify […]

Read More
Topics: Drug Safety, Model-based Drug Development, PBPK Modeling and Simulation, PK/PD Modeling and Simulation

Every Ending has a New Beginning

Nathan Teuscher

I created the Learn PK/PD site in May 2010 in response to a communication issue that I was facing in my daily work in the world of clinical pharmacology and pharmacokinetics. In my first post, I stated the reason for creating my blog and the website: My blog is dedicated to providing clear, concise, accurate, and […]

Read More
Topics: PK/PD Modeling and Simulation

Highlights of the Quebec “Drug Discovery to Development” Symposium

Mark Reimer

In today’s drug development climate, we’re encouraged to “think global, act local.” I have had the privilege of supporting the development of important new therapies for clients around the globe. But sometimes, it is helpful to take a step back and look at the exciting science going on in your own backyard. With that spirit […]

Read More
Topics: Model-based Drug Development, PK/PD Modeling and Simulation

Effective Communication for Pharmacometricians with Joga Gobburu

Suzanne Minton

The modeling and simulation revolution is transforming our approach to drug development. Quantitative pharmacology models can yield valuable insights that help sponsors make better decisions regarding their drug programs. For pharmacometricians to influence decision making, they must be able to effectively communicate. Dr. Joga Gobburu is a Professor at the University of Maryland Schools of […]

Read More
Topics: Model-based Drug Development, PK/PD Modeling and Simulation

The Special Opportunities for Modeling and Simulation in Oncology Drug Development

Rik de Greef and Ellen Leinfuss

In his most recent New York Times Magazine piece, “The Improvisational Oncologist,” Dr. Siddhartha Mukherjee, author of The Emperor of All Maladies: A Biography of Cancer, wrote, “In an era of rapidly proliferating, precisely targeted treatments, every cancer case has to be played by ear.”

Read More
Topics: Clinical Trial Design, Model-based Drug Development, PBPK Modeling and Simulation, PK/PD Modeling and Simulation

On the Road Again: Leveraging the Power of Phoenix

Maria Saluta

Last year during our inaugural Phoenix Roadshow workshop program across the US, Europe and Asia, we gained valuable feedback and ideas from our customers on “All Things Phoenix.” Based on the success of that program, and with new updates and case studies to share with our users, we commenced our 2nd Annual Phoenix Roadshow in […]

Read More
Topics: Model-based Drug Development, PK/PD Modeling and Simulation

The Rise of Model-Informed Drug Development in China

Christine Yuying Gao

China’s pharmaceutical market is poised for growth. By 2020, it is expected to grow to approximately $120 billion. Today, China’s 1.36 billion people represent 20 percent of the world’s population. Yet, they comprise only 1.5 percent of the global drug market. From a demographic perspective, nine percent of the Chinese population today is over 65 […]

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

Diving into Best Practices for Pooling Clinical Trial Data

Steve Sibley

If you’ve worked with a client drug development team approaching submission for approval, it’s likely you’ve heard discussions like this: Team member 1: “But, you can’t integrate the data from those studies because the treatment durations are different.” Team member 2: “That doesn’t matter, we still have to pool the results into a single integrated […]

Read More
Topics: PK/PD Modeling and Simulation, Regulatory Writing

Get Ready for CDISC-SEND!

Maria Saluta

Towards the end of 2016, the US Food and Drug Administration (FDA) and the Japan Pharmaceuticals and Medical Devices Agency (PMDA), will require electronic submissions of certain nonclinical data using the CDISC SEND standard format. Other regulatory agencies, including the European Medical Agency (EMA), Korean Ministry of Food and Drug Safety, and China Food and […]

Read More
Topics: Model-based Drug Development, PK/PD Modeling and Simulation

Reference-Scaled Average Bioequivalence

Ana Henry

The standard approach for approval of generic drugs is to run a bioequivalence study to demonstrate that a generic product is comparable to an  approved (i.e. reference) drug in their rate and extent of absorption.    The rate and extent of drug absorption are determined from the pharmacokinetic parameters: peak concentration (Cmax) and the area under […]

Read More
Topics: Model-based Drug Development, PK/PD Modeling and Simulation

Automated Prediction of First-In-Man Dosing Using Pre-Clinical PK Data

Serge Guzy

If ever there was a cautionary tale illustrating the importance of getting allometric scaling of drugs right, it’s the story of Tusko the elephant. In 1962, Tusko was living at the Lincoln Park Zoo in Oklahoma City where he received a dose of the psychomimetic drug, lysergic acid diethylamide, better known as LSD. The dose […]

Read More
Topics: PK/PD Modeling and Simulation

Educating the World in Biosimulation: Creating Certara University

Frank Garafalo

“Fundamentally Certara is a collection of academic discoveries and scientific minds who are charged with transforming patient care and improving the most crucial research and development and regulatory decisions.  Our training organization and methodology must be equally accountable for this mission.” – Edmundo Muniz I heard these inspiring words from our CEO during my first […]

Read More
Topics: Model-based Drug Development, PK/PD Modeling and Simulation, Training

How Biosimulation Technology Impacted the “Class of ’15”

Ellen Leinfuss

It’s been almost 20 years since the FDA approved a group of New Drug Applications (NDA) and Biologic License Applications (BLA) as large as the class of ’15. The 45 approved drugs represent a 10% increase over the prior year and an increase of 114% from the beginning of the decade. What accounts for this increase and how biosimulation has impacted the rise in approvals is the subject of this article.

Read More
Topics: Model-based Drug Development, PBPK Modeling and Simulation, PK/PD Modeling and Simulation

Tips for custom IVIVC models in Phoenix

Simon Davis

The IVIVC tool within Phoenix is a convenient and powerful tool to build an in vivo-in vitro correlation model using dissolution experiments and real in vivo profiles.  This module can support your organization in formulation development and even in applying for biowaivers. The tool has a flexible library of built-in models that can be modified […]

Read More
Topics: Model-based Drug Development, PK/PD Modeling and Simulation, Training

How Biosimulation Can Bring New Immuno-Oncology Treatments to Patients

Rik de Greef

Immuno-oncology, which harnesses the patient’s own immune system to fight cancer, is one of the hottest areas in drug development today. In recent years, the FDA has granted breakthrough therapy designations to multiple immuno-oncology drugs for a variety of oncology indications including advanced non-small cell lung cancer and melanoma. Over the last two decades, PK/PD modeling and simulation (M&S) has played a growing role in oncology drug development. In this blog post, I’ll discuss how M&S (also known as biosimulation) can help support some of the unique challenges that immuno-oncology programs face.

Read More
Topics: PK/PD Modeling and Simulation
Learn More
LinkedIn