Clinical Pharmacology Strategy

Supporting the Approval of a Treatment for a Neglected Tropical Disease

Medicines Development for Global Health (MDGH), a not-for-profit biopharmaceutical company, needed integrated, model-informed drug development expertise to support developing a treatment for river blindness. Learn how Certara’s clinical pharmacology, pharmacometrics, and regulatory strategy expertise yielded a significant financial, scientific, and regulatory ROI to MDGH.

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Certara Announces the Formation of a New Practice Area Focused on Global Health

PRINCETON, NJ – July 9, 2019 – Certara has formed a new practice area called Certara Global Health (CGH) to focus its technological expertise on helping to achieve equity in health for all people worldwide.

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Found in Translation: Building an Early Development Strategy for Complex Biologics

This webinar described some important strategic considerations for successful development of complex biologics including appropriate data collection and timings, analyses requiring cross-functional data integration, and key pharmacology-related critical questions.

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Using Simcyp-guided ADME Biomarker Discovery to Prospectively Identify Patients at High Risk of Drug Toxicity

Posted by Thomas Polasek

on Jan 25, 2019 8:00:25 AM

As novel molecular targets are being continuously discovered and new treatments developed, oncology is one of the biggest therapeutic areas in precision medicine. In particular, new targeted anti-cancer medications that are taken orally, such as the protein kinase inhibitors (KIs), are ideal candidates for model-informed precision dosing (MIPD) technologies.1 One of these technologies is called physiologically-based […]

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

Lessons Learned: Case Studies of Apocalyptic Clinical Pharmacology

Posted by Graham Scott

on Dec 14, 2018 8:00:40 AM

Apocalyptic clinical pharmacology helps drug developers save resources and time through providing a framework for understanding the interaction of the drug under development with the biological system. This framework also helps answer questions from regulatory authorities who are evaluating the safety and efficacy of the drug. Making informed decisions throughout the drug development process requires […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation

Using Virtual Twin™ Technology to Predict Drug Exposure in Individual Patients

Posted by Thomas Polasek

on Nov 16, 2018 8:00:45 AM

Physiologically-based pharmacokinetics (PBPK) is a valuable resource to support decisions throughout drug development for sponsors and regulators. PBPK is used extensively to predict drug-drug interactions (DDIs), to inform dosing and clinical study design, to predict drug exposure, to predict variation in drug clearance, and to understand mechanisms of drug disposition. Virtual Twin technology, based on […]

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

Introduction to Apocalyptic Clinical Pharmacology in Drug Development

Posted by Graham Scott

on Nov 2, 2018 8:00:45 AM

In this blog, I will introduce “apocalyptic clinical pharmacology” and provide a framework for using this approach in drug development, which can save resources and time. Apocalyptic clinical pharmacology in drug development provides value offering a framework for thinking about the relationship between the drug dose and the biological system. What is apocalyptic clinical pharmacology? […]

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

Using Virtual Twin™ Technology for Model-informed Precision Dosing

Posted by Thomas Polasek

on Oct 5, 2018 8:00:04 AM

In a recent Expert Review of Clinical Pharmacology article, I assessed the status and future direction of precision dosing in clinical medicine.1 Model-informed precision dosing (MIPD) is a modeling and simulation (M&S) approach in healthcare that is used to predict the most effective and/or least toxic drug dose for a patient. MIPD could revolutionize healthcare […]

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

Clinical Pharmacology Gap Analysis: Your FAQs

Posted by Julie Bullock

on Sep 21, 2018 8:00:23 AM

As drug development has become more complex, with a higher risk of failure, greater uncertainty, and increased expense, the need for a quantitative and regulatory science-based strategy becomes clear. The first step in that performing that strategic assessment is a gap analysis and roadmap. Over the last couple of months, I’ve written a series of blog […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation

Clinical Pharmacology Gap Analysis: Lessons Learned

Posted by Julie Bullock

on Aug 10, 2018 8:00:45 AM

Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these needs, and providing a framework for how to satisfy them. This tool can create value for drug development programs. While gap analysis can be performed at any point in the drug development continuum, early engagement is best for maximizing its benefits. […]

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

Application of Tracer Kinetics in Drug Development: A Valuable but Underused Tool in Clinical Pharmacology

In this webinar, Pau Aceves, Associate Director of Consulting Services at Certara, presented case studies on how tracer kinetics were used to inform development of new drugs for lung, CNS, and liver diseases. By watching this webinar, you will learn how tracer kinetics can leveraged for PK, PD, and in silico modeling applications.

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Validate Your Expertise in PK/PD NCA Analysis Through Certara Professional Certification

Posted by Maria Saluta

on Jul 13, 2018 8:00:03 AM

In the ongoing commitment to education and coinciding with the launch of Phoenix 8.1, Certara has introduced a new certification program available through Certara University. The new online accreditation program validates the scientists’ PK/PD data analysis skills using Certara software such as Phoenix WinNonlin and expands their professional reach. I caught up with Ana Henry, […]

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

Overcoming Pitfalls and Challenges with Software Validation

Posted by Noreen Muscat

on Jun 29, 2018 8:00:56 AM

As a quality consultant and quality system subject matter expert in the Life Sciences Industry for over 25 years, I have worked for many pharmaceutical companies both large and small and as a consultant with many clients in the pharmaceutical, biotech, and medical device industries. These clients possess a range of experience in software validation—from […]

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Topics: PK/PD Modeling & Simulation

Accomplish More with Phoenix

Posted by Venkateswari Muthukrishnan

on Jun 8, 2018 8:00:31 AM

Phoenix 8.1, the newest version of Certara’s innovative PK/PD modeling and simulation software used globally by researchers and drug developers in pharma, academia, and regulatory agencies, will be available on June 15, 2018. Major enhancements were introduced in the Phoenix workbench last year. And as an ongoing commitment to support compliance and efficiency, many features […]

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Topics: PK/PD Modeling & Simulation

A House Divided—The Interplay of Bioanalysis and Pharmacokinetics

This webinar introduced the importance of bioanalysis and its downstream effects on clinical development and clinical pharmacology.

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Metformin Treatment of Type 2 Diabetes Mellitus in Pregnancy: Update on Safety and Efficacy

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Using M&S to Evaluate Oncology Drug Dosing

Posted by Maria Saluta

on Apr 13, 2018 8:00:06 AM

There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be altered in cancer patients due to demographic and physiological differences as compared to healthy volunteers, and (3) cancer patients face elevated drug-drug interaction (DDI) risk […]

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

Certara’s Best of the Blog 2017

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

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Using a Pharmacology to Payer Framework to Support Product Development

Posted by C. Kirkpatrick, C. Rayner

on Mar 16, 2018 1:20:13 PM

Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains with a variety of domain-specific approaches and applications. The pharmacology to payer (P2P) concept is a way to connect independent domains to address drug development market failures. As an initial proof of concept, we collaborated with a team of clinical pharmacologists, […]

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Topics: Clinical Pharmacology Strategy

Certara and Faculty from UNC Eshelman School of Pharmacy to Launch New Pharmacometrics Skills Competition at ASCPT 2018 Annual Meeting

PRINCETON, NJ – Mar. 12, 2018 – Certara today announced that it is partnering with faculty at the UNC Eshelman School of Pharmacy to launch the Model-informed Drug Development (MIDD) Gran Prix at the 2018 American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting.

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