PBPK Modeling & Simulation

Modelling Toxicodynamic Feedback is Critical in Recovering Toxicokinetics in Acetaminophen Overdose

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Mechanisms of Physiological Changes in Drug Exposure in Cancer Patients

This webinar discussed how to use a PBPK cancer population to investigate tumor disposition and therefore, impact on treatment regimens.

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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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Investigating Impacts of Model Parameters Correlations in Global Sensitivity Analysis: Determining the Most Influential Parameters of a Minimal PBPK Model of Midazolam

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Development and Performance Evaluation of a semi-mechanistic PBPK Model for Topical Ocular Delivery of Pilocarpine and Timolol to Rabbit Eye

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Transporter inhibition: modelling in-vitro Transwell Assays

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Development of Paclitaxel PBPK Model to Predict Tumour Concentration in Cancer Patients

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Optimize Immuno-oncology Drug Discovery and Development Using Quantitative Systems Pharmacology

A Quantitative Systems Pharmacology (QSP) approach for developing combination immune-oncology therapies can be used to better predict effective drug combinations, especially to more accurately correlate the physiological differences between preclinical models and human patients.

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Certara’s Simcyp PBPK M&S Technology Achieves First FDA Virtual Bioequivalence Approval for ‘Complex’ Generic Drug

PRINCETON, NJ – June 12, 2019 – Certara’s Simcyp®️ physiologically-based pharmacokinetic (PBPK) modeling and simulation technology was used to demonstrate bioequivalence (BE) for the US Food and Drug Administration (FDA) approval of a complex generic drug on the agency’s abbreviated new drug application (ANDA) pathway.

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The Fantastic 4: Simcyp Rat, Mouse, Dog, and Monkey Simulators

June 27, 2019 –This webinar discussed the Simcyp Animal Simulators, and the role they play in developing safer and more effective medications in the human and veterinary drug development arena.

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Changing the Game in Oncology Drug Development and Patient Access

Maximize your understanding of your anti-cancer drug’s safety and efficacy profile to achieve regulatory and commercial success with Certara’s strategic and technology-enabled services across the entire drug development continuum – from pre-clinical first-in-human studies to regulatory submissions, health economics/outcomes research and market access value communication.

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PBPK for the Pill: An Approach to Assess the Risk-Benefit of Drugs

This webinar discussed how Certara’s PBPK platform, the Simcyp®️ Simulator, was used to assess the risk-benefit profile for ethinylestradiol, the estrogen component of most combined oral contraceptives.

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Development of a Physiologically-Based Pharmacokinetic Model for Topical Lidocaine in Order to Predict Systemic Absorption in Healthy Volunteers, Geriatrics, and Pediatrics

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Evaluation of Maternal Drug Exposure Following Administration of Dexamethasone and Betamethasone During Pregnancy Using Physiologically-Based Pharmacokinetic Modeling

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Certara Adds 4 Global Leaders to its Simcyp PBPK, QSP and QSTS M&S Division

New executives’ scientific, operational and consulting expertise will support Simcyp’s footprint in drug development and regulatory decision-making.

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Global Regulatory Agencies Increase Adoption of Phoenix PK/PD M&S Software for Drug Reviews

PRINCETON, NJ – Apr. 4, 2019- ANVISA, MHRA and PMDA join EMA, FDA, NMPA and TGA in expanding their Phoenix software licenses to evaluate drug regulatory submissions

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Computational Comparative Pharmacology: Designing Better Drugs for Animals (and Humans)

Modeling and simulation can help veterinarians provide better care for animals and guide research study design thereby maximizing the knowledge gained from research studies whilst minimizing the number of animals used. In this webinar, we looked at how PBPK modeling can be used to predict the absorption, distribution, metabolism, and excretion of drugs in humans and other animal species.

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Managing Immunogenicity Using Quantitative Systems Pharmacology

Posted by Piet van der Graaf

on Feb 22, 2019 1:46:07 PM

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

PBPK’s Pivotal Role in Modern Drug Development: Busting Common Myths and Misconceptions

This white paper addresses common PBPK myths and misconceptions and demonstrates how this approach is an industrial and regulatory necessity in modern drug development.

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Certara Launches Version 18 of Its Physiologically-based Pharmacokinetic (PBPK) Simcyp Simulator

January 29, 2019 – New features designed to support the delivery of safer, more effective medications include advanced food staggering and tumor models for optimizing trial design and dose selection.

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