The Certara Blog: PBPK Modeling & Simulation

Benefits of Apocalyptic Clinical Pharmacology During Regulatory Review

When developing a drug, pharmaceutical companies need to answer many questions to successfully undergo regulatory review and bring the drug to market. Apocalyptic clinical pharmacology is a framework that drug developers can use to uncover essential relationships between the drug dose and response or outcome. In other recent blog posts, I have covered what the […]

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Managing Immunogenicity Using Quantitative Systems Pharmacology

The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Biologically-based therapeutic drugs comprise monoclonal antibodies (MAbs), vaccines, recombinant hormones and proteins, antibody-drug conjugates, RNAi, antisense, blood factors, and other large molecules. Although the success of biologics has been demonstrated, there are inherent operational and […]

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

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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Lessons Learned - Case Studies of Apocalyptic Clinical Pharmacology

Lessons Learned: Case Studies of Apocalyptic Clinical Pharmacology

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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Using Virtual Twin Technology to Predict Drug Exposure in Individual Patients

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

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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Using Virtual Twin Technology for Model-informed Precision Dosing

Using Virtual Twin™ Technology for Model-informed Precision Dosing

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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Clinical Pharmacology Gap Analysis - Your FAQs

Clinical Pharmacology Gap Analysis: Your FAQs

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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Clinical Pharmacology Gap Analysis - Lessons Learned

Clinical Pharmacology Gap Analysis: Lessons Learned

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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Beam Me Up, Scotty! Probing the Mechanisms of Transporter-mediated Drug Disposition

Beam Me Up, Scotty! Probing the Mechanisms of Transporter-mediated Drug Disposition

Over the last 15 years, the importance of drug transporters has become paramount for understanding drug absorption, distribution into tissues, and in particular, drug-drug interactions (DDIs). In vitro-in vivo extrapolation (IVIVE) is an approach to link in vitro systems to the human in vivo situation using algorithms and physiologically-based scaling factors. In this blog, I […]

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

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

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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Using M&S to Evaluate Oncology Drug Dosing

Using M&S to Evaluate Oncology Drug Dosing

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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How to Maximize the Benefits of Clinical Pharmacology Gap Analysis

How to Maximize the Benefits of Clinical Pharmacology Gap Analysis

Many companies have tried and true clinical pharmacology practices. But when the rubber hits the road for your drug program, will these practices support regulatory success? Has your historic approach to drug development been updated to include the latest modeling and simulation innovations? It’s hard to change how you’ve historically done things. But, do you […]

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Skin in the Game - Mechanistic Modeling of Dermal Drug Absorption

Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption

The ability to estimate systemic exposure from dermal absorption is essential in developing new dermatological medications or assessing the toxicological liability of commercially-used chemicals. Historically, animal models were used to evaluate dermal drug absorption prior to clinical testing. However, both differences in human and animal physiology as well as ethical concerns over animal testing have […]

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Using Virtual Cancer Patients to Probe the Mechanisms of Oncology Drug Disposition

Using Virtual Cancer Patients to Probe the Mechanisms of Oncology Drug Disposition

Oncology drug developers face a distinct set of challenges. Oncology drugs are often very toxic which precludes conducting clinical trials in healthy volunteers. In addition, cancer patients differ from healthy people in terms of their demographics and physiology. These changes mean that the pharmacokinetics of drugs may be altered in this population compared to healthy […]

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Using PBPK Models to Assess Fetal Drug Exposure

Using PBPK Models to Assess Fetal Drug Exposure

The tragedy of thalidomide provides a cautionary tale about the potential for birth defects resulting from fetal exposure to drugs. Thalidomide was used to treat morning sickness in pregnant women. By the time it was banned in 1962, more than 10,000 children had been born with thalidomide-induced birth defects. “Phocomelia,” wherein babies were born with […]

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