Simcyp

Certara introduces Simcyp™ Biopharmaceutics software to increase efficiency of novel and generic drug formulation & development  

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火曜日, 11月 21, 2023
Holocene, Drug development, PBPK, Absorption, FDA, CMC, VBE, Simcyp, BCS, Complex, Element, Pediatrics, Biopharmaceutical, Safety, Fine chemical

PRINCETON, N.J., Nov. 21, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the introduction of Simcyp™ Biopharmaceutics software.

Key Points: 
  • PRINCETON, N.J., Nov. 21, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the introduction of Simcyp™ Biopharmaceutics software.
  • It is designed for use by biopharmaceutic, formulation, and CMC scientists to aid in formulating complex novel and generic small molecule medicines quickly and cost effectively.
  • Simcyp Biopharmaceutics software is part of the Simcyp Simulator biosimulation platform, which has supported label claims for more than 100 approved novel therapies .
  • Simcyp Biopharmaceutics software includes a VBE module that automates elements of trial design significantly enhancing opportunities for attaining biowaivers.

Certara Simcyp™ Group Awarded Two New Grants from US FDA

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火曜日, 8月 29, 2023
VBE, Skin, PBPK, Drug development, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Absorption, Simcyp, Risk, Food, Automation, Pharmaceutical industry

These capabilities will help enable safer, faster and more cost-effective product development of both complex generics and novel drugs.

Key Points: 
  • These capabilities will help enable safer, faster and more cost-effective product development of both complex generics and novel drugs.
  • “We are proud to collaborate with the FDA in developing innovative model-informed approaches for accelerating drug development of complex generic and innovator drugs,” said Rob Aspbury, President of Certara, Scientific Software.
  • “The Simcyp Simulator has already proved its ability to replace clinical studies in both VBE and dermal absorption.
  • Topical products undergo changes immediately upon application due to formulation metamorphosis, which may alter the critical characteristics of the formulations.

Certara announces the release of Simcyp™ PBPK Simulator Version 22, expanding ability to simulate untested scenarios for new patient and therapeutic types

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火曜日, 3月 7, 2023
Growth, FDA, MBI, Simulation, SVP, Pharmacokinetics, Trial of the century, QSP, LAI, PBPK, Lactation, Doctor of Philosophy, Drug development, Pregnancy, Excipient, Metabolism, Patient, Quantitative systems pharmacology, PD, Generic drug, Pharmaceutical industry, Simcyp, Pharmacodynamics, Certara

The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically based pharmacokinetics (PBPK) platform and is being applied to small and large molecule drug candidates.

Key Points: 
  • The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically based pharmacokinetics (PBPK) platform and is being applied to small and large molecule drug candidates.
  • The Simcyp Simulator has proven use cases across drug development, including first-in-human dosing, extrapolation to special populations, bioequivalence testing, optimizing clinical study design and predicting drug-drug interactions (DDIs).
  • “We are excited to expand and improve upon the Simcyp Simulator capabilities to advance modern drug development with the launch of our latest version,” said Masoud Jamei, Ph.
  • For more information about the Simcyp PBPK Simulator and Simcyp Designer, please visit: https://www.certara.com/software/simcyp-pbpk/

Certara Introduces New Simcyp™ Discovery Simulator for Early-Stage and Translational Drug Development

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火曜日, 6月 28, 2022
FIH, European Medicines Agency, CEO, GLOBE, Pharmacokinetics, Risk, Food, Simcyp, PBPK, Technology, Patient safety, Software, Human, Medicines and Healthcare products Regulatory Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, DDI, Drug discovery, Doctor of Philosophy, Pharmaceutical industry, Certara

Derived from the industry-leading Simcyp Simulator, Simcyp Discovery increases confidence in early-stage development decisions using physiologically-based pharmacokinetic (PBPK) modeling and simulation.

Key Points: 
  • Derived from the industry-leading Simcyp Simulator, Simcyp Discovery increases confidence in early-stage development decisions using physiologically-based pharmacokinetic (PBPK) modeling and simulation.
  • We are pleased to offer our new Simcyp Discovery Simulator to help identify and move forward the most promising new drug candidates for further investigation, said William F. Feehery, Ph.D., CEO of Certara.
  • With Simcyp Discovery, scientists can apply PBPK earlier in the development process to better inform critical decisions and reduce risk of drug failure.
  • For more information about Simcyp Discovery, please visit: https://www.certara.com/simcyp-overview/simcyp-discovery/
    Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development.

Certara Announces FDA Renewal and Expansion of Certara’s Biosimulation Software for Reviewing Regulatory Submissions

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火曜日, 12月 21, 2021
IVIVC, PBPK, GLOBE, Review, Vitro, Drug discovery, FDA, Trial of the century, Simcyp, Â, Doctor of Philosophy, Technology, CEO, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Drug development, Nasdaq, Food, R, Medical device

In total, there are 12 divisions and offices of the FDA using Certaras software for internal research and to independently analyze, verify and review regulatory submissions.

Key Points: 
  • In total, there are 12 divisions and offices of the FDA using Certaras software for internal research and to independently analyze, verify and review regulatory submissions.
  • It is a privilege to continue providing software that global regulatory agencies can rely on to inform their reviews of regulatory submissions, said William F. Feehery, Ph.D., CEO of Certara.
  • We are pleased that more scientists at the FDA are using our biosimulation software to support the development of safe and effective medicines.
  • The FDA uses Certaras Phoenix software including WinNonlin, NLME and In Vitro-In Vivo Correlation (IVIVC) toolkit as well as the Companys Trial Simulator software.

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) Renews Licenses of Certara’s Biosimulation Software for Evaluating Regulatory Submissions

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木曜日, 6月 24, 2021
Life sciences, Health sciences, Articles, Systems biology, Biosimulation, Pharmaceuticals policy, Simcyp, PMDA, Biopharmaceutical, Pharmaceutical industry in China

PRINCETON, N.J., June 23, 2021 (GLOBE NEWSWIRE) -- Certara, a global leader in biosimulation, today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has renewed its licenses of Certaras Simcyp and Phoenix biosimulation software.

Key Points: 
  • PRINCETON, N.J., June 23, 2021 (GLOBE NEWSWIRE) -- Certara, a global leader in biosimulation, today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has renewed its licenses of Certaras Simcyp and Phoenix biosimulation software.
  • The PMDA has been using Certaras biosimulation software since 2014.
  • Certara accelerates medicines to patients using biosimulation software and technology to transform traditional drug discovery and development.
  • Its clients include 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.

Certara Releases Simcyp™ PBPK Simulator Version 20, Including Newly Expanded Biologics Software

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水曜日, 1月 27, 2021
Health, Clinical trials, Research, Pharmaceutical, Science, Biotechnology, Life sciences, Health sciences, Pharmaceutical sciences, Pharmacokinetics, Pharmacy, Simcyp, Physiologically based pharmacokinetic modelling, Biotechnology, Biosimulation, Bioequivalence, Biopharmaceutical, Simulation

Certara, Inc., the global leader in biosimulation, today announced the release of version 20 of its Simcyp Physiologically-based Pharmacokinetic (PBPK) Simulator platform.

Key Points: 
  • Certara, Inc., the global leader in biosimulation, today announced the release of version 20 of its Simcyp Physiologically-based Pharmacokinetic (PBPK) Simulator platform.
  • Simcyp PBPK Simulator version 20 provides new models for maternal health, virtual bioequivalence to attain biowaivers, and analysis of long-acting injectable drugs.
  • It also delivers a newly expanded biologics module, Simcyp Biologics Simulator, that enables scientists to model a wider range of biologic modalities to accelerate drug development.
  • Simcyp PBPK Simulator version 20 offers new and enhanced models for maternal health, such as assessing drug performance during pregnancy and lactation.

Food and Drug Administration Renews and Expands Use of Certara’s Biosimulation Software for Reviewing Regulatory Submissions

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木曜日, 10月 1, 2020
Technology, FDA, Software, Practice Management, Biotechnology, Networks, Health, Pharmaceutical, Data management, Simcyp, Food and Drug Administration

Eleven divisions and offices of the FDA use Certaras software for internal research and to independently analyze, verify, and review regulatory submissions.

Key Points: 
  • Eleven divisions and offices of the FDA use Certaras software for internal research and to independently analyze, verify, and review regulatory submissions.
  • Furthermore, the FDAs Office of Pharmaceutical Quality recently ordered Simcyp user licenses, expanding the FDAs use of the platform.
  • The agency uses Simcyp software to independently analyze, verify, and review sponsor IND, BLA, NDA, ANDA, and other submissions.
  • "Regulators around the world rely on our sophisticated software to inform their reviews of regulatory submissions, said Rob Aspbury, Ph.D., president of the Simcyp division at Certara.

Certara Launches New Version of Simcyp® Simulator for Population-Based Pharmacokinetic Modeling and Simulation

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水曜日, 4月 29, 2020
Health, Technology, Software, Clinical trials, Pharmaceutical, Biotechnology, Simcyp, Pharmacy, Life sciences, Articles, Pharmacokinetics, Natural sciences

Certara, the global leader in model-informed drug development announced today the launch of version 19 of its Simcyp Population-based Simulator.

Key Points: 
  • Certara, the global leader in model-informed drug development announced today the launch of version 19 of its Simcyp Population-based Simulator.
  • The Simcyp Simulator streamlines drug development through the modeling and simulation of pharmacokinetics (PK) and pharmacodynamics (PD) in virtual patient populations.
  • The Simcyp Consortium of leading pharmaceutical and biotechnology companies meet to discuss the latest scientific developments in the area of modeling and simulation and guide the future development of the Simcyp Simulator.
  • The Simcyp Simulator continues to advance modern drug development, said Rob Aspbury, PhD, Simcyps president and managing director.

Certara’s Simcyp Division Acquires Modeling and Simulation Platform for Neurodegenerative Diseases from In Silico Biosciences, Inc.

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火曜日, 2月 25, 2020
Science, Software, Biotechnology, Research, Pharmaceutical, Health, Data management, Technology, Simcyp, Simulation

It is the right technology at the right time for neurodegenerative disease drug development.

Key Points: 
  • It is the right technology at the right time for neurodegenerative disease drug development.
  • Certaras Simcyp division is the undisputed leader in mechanistic modeling for QSP.
  • Simulation of the neuronal circuits produces firing patterns, and the transformed outputs are calibrated with drug effects on clinically meaningful biomarkers.
  • Dr. Geerts will lead a new Certara QSP consortium that is being formed in 2020, focused on neurodegenerative diseases.