This white paper addresses common PBPK myths and misconceptions and demonstrates how this approach is an industrial and regulatory necessity in modern drug development.
Read MoreSolution: PBPK Modeling & Simulation
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.
Read MoreUsing 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 […]
Read MoreLessons 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 […]
Read MoreWhat’s New in the Simcyp Simulator v18?
Watch this webinar with Nikunjkumar Patel, Shriram Pathak, and Rachel Rose to learn how the latest updates in the Simcyp Simulator v18 will help support developing safer, more effective medications.
Read MoreUsing 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 […]
Read MoreUS FDA Awards Certara’s Simcyp Division Two New Dermal Virtual Bioequivalence Grants
PRINCETON, NJ – Nov. 14, 2018 – Certara today announced that it has been awarded two new dermal virtual bioequivalence grants by the US Food and Drug Administration (FDA).
Read MoreMulti-phase Multi-layer Mechanistic Physiologically-based Pharmacokinetic Dermal Absorption Model Verification Including Inter- and Intra-individual Variability Assessment Using Nicotine as a Model Drug
A Comprehensive and Systematic Review of Gastric pH and Factors Affecting Gastric Fluid Volume Dynamics Under Fasted and Fed Conditions in Humans
Phase Behavior and Transformation Kinetics of a Poorly Water Soluble Weakly Basic Drug Upon Transit from Low to High pH Conditions
Predicting Depth Resolved Concentrations in the Dermis Using PBPK Modeling: Design, Development and Verification of the Model with Five Drugs
SOT Annual Meeting and ToxExpo
ASCEPT Annual Scientific Meeting
Application of In Silico PBPK Absorption Modeling to Justify Drug Product Dissolution Specifications—Analysis of Regulatory Submission Case Studies and Its Impact on Concept of Virtual BE
FDA Renews and Expands Its Use of Certara Software to Facilitate New Drug and Biologics Regulatory Review
PRINCETON, NJ – Oct. 9, 2018 – Certara today announced that the US Food and Drug Administration (FDA) has renewed, and in many cases increased, its number of Certara software licenses for reviewing new drug and biologics applications.
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