PBPK 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, […]

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

Using PBPK Models to Optimize Anti-HIV Drug Dosing in Pregnant Women

Angela Colbers

Antiretroviral drugs are a critical tool in preventing mother-to-child transmission of HIV. Yet, antiviral treatment options for pregnant women lag behind the “non-pregnant” population. In this blog post, I’ll discuss the reasons for this lag and how physiologically-based pharmacokinetic (PBPK) models can simulate PK during pregnancy and thus help optimize dosing for this special population. […]

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Topics: PBPK Modeling & Simulation

A Targeted Approach to Medicine and Dosing—A Necessity for Sustainable Healthcare

Maria Saluta

President Obama, during his 2015 State of the Union Address, launched the Precision Medicine Initiative “to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care.” The message given to the American people reinforced the critical need to implement precision medicine into […]

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Topics: PBPK Modeling & Simulation

How to Harness Public Clinical Trial Data to Assess Drug Candidates

Maria Saluta

Publicly available clinical trial data represent an underutilized source of information. If properly extracted and analyzed, the data provide valuable input for facilitating go/no go decisions, performing comparative effectiveness and portfolio evaluations in support of in/out licensing, and optimizing overall drug development decisions, including dose and dosing regimens. Clinical Outcomes Database Explorer, CODEx, is an […]

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Topics: Model-based Meta-analysis

6 Signs You Need Help with Submission Planning

Steve Sibley

Setting and adhering to a timeline for planning, drafting, reviewing, and editing regulatory documents needed for the submission dossier is a major challenge for drug development teams. I think of this process as having three phases: “discovery, drive, and survive.” In a previous blog post, I discussed the planning that occurs in the discovery phase. […]

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Topics: Regulatory & Medical Writing

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

Modeling & Simulation Take a Prominent Role in FDA’s Newly Published DDI Guidances

Ellen Leinfuss

On October 25, 2017, the FDA published two new guidance documents on drug-drug interactions (DDI). These guidance documents replace the February 2012 guidance, “Drug Interaction Studies—Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations.” According to the FDA, these new guidances reflect the agency’s current thinking and greater learnings on DDI and provides a […]

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Topics: PBPK 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 […]

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Topics: PK/PD Modeling & Simulation

A Chat with Biopharmaceutics Expert, Professor Jennifer Dressman

Suzanne Minton

Professor Jennifer Dressman is fearless—both in her science and her career. Born and raised in Australia, she holds degrees in pharmacy and a doctorate in pharmaceutics. Having held positions at Burroughs Wellcome and the University of Michigan, College of Pharmacy in the United States, she was offered her dream job as a professor at the […]

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Topics: PBPK Modeling & Simulation

The European Regulatory Landscape for Pediatric Drug Development

Barry Mangum

In my 35 years of working to develop safer, more effective medications for children, I’ve often been asked about how to navigate the regulatory landscape in the US and Europe. In a previous blog post, I discussed the latest FDA trends regarding pediatric drug development. In this blog, I’ll focus on the path for achieving […]

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

Agreeing to Submission Document Timelines and Sticking to Them: Fairy Tale or Reality?

Steve Sibley

Does the thought of developing a submission for the marketing approval of a new drug fill you with dread? How do you avoid losing all of your holidays and weekends when developing a submission? Or burning out your team? In my career, I’ve helped teams develop robust submissions with minimal disruption to people’s lives and […]

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Topics: Regulatory & Medical Writing

FDA Reauthorization Act (FDARA) Affirms Commitment to Innovative MIDD Strategies

Ellen Leinfuss

Quietly, without any political rancor, the FDA Reauthorization Act of 2017 (FDARA) was passed by the US Congress and was signed into law by President Trump in late August. The FDARA reauthorizes the Prescription Drug User Act Fee Amendments (PDUFA) for the fifth time, the Medical Device User Act Fee Amendments (MDUFA) for the third […]

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Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology

7 Savvy Ways to Reduce Quantitative Systems Pharmacology Models

Tom Snowden

Modeling and simulation has become an indispensable part of drug development. Historically, the type of modeling employed changes as a drug moves through the stages of drug development—from discovery to pre-clinical testing to clinical trials. At the early stages of drug discovery, we may use systems biology models to identify drug targets and possible compounds, […]

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Topics: Systems Pharmacology

What the FDA Expects from Your Pediatric Drug Program

Barry Mangum

Historically, 80 percent of medicines used in children had little to no data guiding prescribers on proper use. To address this market failure, regulatory legislation for drug development in pediatric patients was passed worldwide over the past decade. The number of drugs tested in and labeled for children has increased dramatically as a result. In […]

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

First-in-human Trials and Going Too FAAH from the Sentry

Graham Scott

Many people in the UK and elsewhere are currently remembering where they were and what they were doing on the day that Diana Princess of Wales died: August 31st marks 20 years since that fateful day. For Clinical Pharmacologists, we may well remember where we were when we heard the news that six volunteers were […]

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Topics: Clinical Pharmacology Strategy

Taming Complex Quantitative Systems Pharmacology Models with Model Reduction

Tom Snowden

Quantitative systems pharmacology (QSP) combines computational modeling and experimental data to examine the relationships between a drug, the biological system, and the disease process. This emerging discipline integrates quantitative drug data with knowledge of its mechanism of action. QSP models predict how drugs modify cellular networks in space and time and how they impact and […]

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Topics: Systems Pharmacology

New FDA Commissioner Endorses Use of M&S to Advance Drug Development

Suzanne Minton

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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Topics: Clinical Transparency & Disclosure, Model-based Meta-analysis, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing

Quantitative Systems Toxicology—Taking the Cue from Aristotle

Maria Saluta

“The whole is greater than the sum of its parts” -Aristotle This quote from the great 4th century BCE Greek philosopher and scientist has become the mantra for many endeavors, sectors, organizations, and disciplines. From biology, chemistry, and physics to agriculture, engineering, and business, it is the foundation for synergy. What is the connection between […]

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Topics: Systems Pharmacology

Speaking into the Ether: Challenges of the Virtual Pharma Workplace

P Bonate, S Tannenbaum

In today’s global pharma working environment, virtual interactions are sometimes more common than live exchanges. Many people work virtually through teleconferences, video conferences, instant messaging, phone calls, and emails. Through flexible schedules and working remotely, some people spend the majority of their day without seeing or hearing their colleagues. Honing your skills Pharmacometricians are like […]

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Topics: PK/PD Modeling & Simulation

Using Model Reduction to Bridge the QSP-Pharmacometrics Divide

Tom Snowden

Quantitative systems pharmacology (QSP) models are generally too large to be validated or fit in a traditional sense and they can become intractable to standard methods of analysis or even to the modeler’s own intuition. Model reduction can alleviate these issues of complexity by eliminating portions of a system that have minimal effect upon the […]

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Topics: Systems Pharmacology
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