Physiologically based pharmacokinetic modelling

NMPA’s Center for Drug Evaluation Adds Licenses of GastroPlus®

Retrieved on:

Wednesday, August 4, 2021

Biotechnology, Health, Pharmaceutical, Technology, Software, Simulation software, Simulations Plus, Health sciences, Pharmacokinetics, NMPA, National Medical Products Administration, Simulation, Bioequivalence, Life sciences, Health

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced that it has received an order from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China to add licenses to GastroPlus.

Key Points:

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced that it has received an order from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China to add licenses to GastroPlus.
We have cultivated relationships with different affiliated institutions of NMPA to apply our technology to support the evaluation of drug product specifications and bioequivalence.
Now, researchers at the CDE will add GastroPlus to serve as a key platform for model-informed drug development (MIDD) to aid regulatory reviews.
Serving clients worldwide for 25 years, Simulations Plus, Inc., is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions.

Simulations Plus Releases ADMET Predictor® (X.2)

Retrieved on:

Tuesday, April 27, 2021

Biotechnology, Health, Pharmaceutical, Technology, Software, Health sciences, Pharmacokinetics, Pharmaceutical sciences, Simulation software, Simulations Plus, Natural sciences, Drug discovery, Computational chemistry, ADMET, ADME, Cheminformatics, Physiologically based pharmacokinetic modelling

b'Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced that it has released version 10.2 of its flagship machine learning modeling platform, ADMET Predictor\xc2\xae .

Key Points:

b'Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced that it has released version 10.2 of its flagship machine learning modeling platform, ADMET Predictor\xc2\xae .
The new release will be marketed as APX.2.\nKey enhancements in APX.2 include:\nDr.
David Miller , vice president of ADMET cheminformatics, said: \xe2\x80\x9cAPX.2 enhances the industry-leading discovery PBPK modeling capabilities within ADMET Predictor and cements the program as the premier environment for ADMET property prediction modeling.
Our technology is licensed and applied by major pharmaceutical, biotechnology, chemical, consumer goods companies and regulatory agencies worldwide.

Simulations Plus Releases GastroPlus® Version 9.8.1

Retrieved on:

Tuesday, February 9, 2021

Biotechnology, Health, Pharmaceutical, Technology, Software, Simulation software, Health sciences, Simulations Plus, Physiologically based pharmacokinetic modelling, Simulation, In silico, Life sciences

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced that it has released version 9.8.1 of its flagship physiologically based biopharmaceutics (PBBM) / pharmacokinetics (PBPK) modeling program, GastroPlus .

Key Points:

Simulations Plus, Inc. (Nasdaq: SLP), a leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemical, and consumer goods industries, today announced that it has released version 9.8.1 of its flagship physiologically based biopharmaceutics (PBBM) / pharmacokinetics (PBPK) modeling program, GastroPlus .
For over 20 years, Simulations Plus has been dedicated to improving state-of-the-art software tools, educating scientists worldwide with the best and most innovative science, and advancing in silico modeling and simulation.
Special thanks to the Simulations Plus DDI task force and our government and commercial collaborators for their efforts and counsel.
Simulations Plus, Inc., is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions.

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

Retrieved on:

Wednesday, January 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.

Simulations Plus Enters New Funded Collaboration to Improve Lung Exposure Models for Pulmonary Infection Treatments

Retrieved on:

Tuesday, January 12, 2021

Health, Technology, Infectious diseases, Software, Pharmaceutical, Biotechnology, Simulation software, Pharmaceutics, Pharmacokinetics, Physiologically based pharmacokinetic modelling, Toxicology, Simulations Plus, Modeling and simulation, Simulation, Applied sciences

Additionally, the innovative GastroPlus PBPK/PD models will be validated in specific populations (e.g., disease, geriatric) and published to increase regulatory understanding and acceptance.

Key Points:

Additionally, the innovative GastroPlus PBPK/PD models will be validated in specific populations (e.g., disease, geriatric) and published to increase regulatory understanding and acceptance.
This new collaboration highlights the uniqueness of working with Simulations Plus, added John DiBella , Lancaster division president for the company.
We can take our validated, best-in-class machine learning and PBPK modeling platforms and customize them to our clients specifications as their research priorities are defined.
Simulations Plus, Inc., is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions.

Catalent to Discuss Data-Driven Development and Patient-Focused Dose Design Strategies at AAPS PharmSci 360

Retrieved on:

Tuesday, October 20, 2020

Health sciences, Health, Pharmaceutical sciences, Pharmacy, Physiologically based pharmacokinetic modelling, Catalent, Pharmacokinetics, Pharmaceutics, Pharmaceutical industry, Drug development

ET, Lisa Caralli, Director of Science and Technology, will present "Data-Driven Strategies to Accelerate Your Molecule's Development Path".

Key Points:

ET, Lisa Caralli, Director of Science and Technology, will present "Data-Driven Strategies to Accelerate Your Molecule's Development Path".
Ms. Caralli will discuss evidence-based approaches that help avoid development pitfalls and de-risk the path to clinic, including physiologically-based pharmacokinetic (PBPK) modeling, parallel formulation screening, API sparing techniques and optimal early dosing strategies.
Traditional drug development is largely driven by API pharmaceutics, cost and timelines, and can overlook patients' needs, which may result in a lack of compliance.
Ms. Caralli has over 27 years of industry experience, and in her role at Catalent works with pharmaceutical companies to identify appropriate development pathways for early development drug candidates.

Simulations Plus Partners with Large Pharmaceutical Company to Enhance High-Throughput PBPK Capabilities in ADMET Predictor®

Retrieved on:

Tuesday, April 7, 2020

With the drugmakers input, Simulations Plus will develop enhanced capabilities in its existing HTPK Simulation Module which will incorporate physiologically based pharmacokinetic (PBPK) modeling into the partners discovery platform to support compound screening activities.

Key Points:

With the drugmakers input, Simulations Plus will develop enhanced capabilities in its existing HTPK Simulation Module which will incorporate physiologically based pharmacokinetic (PBPK) modeling into the partners discovery platform to support compound screening activities.
We are pleased to announce this new collaboration which builds on a long-standing relationship with this partner.
This effort will result in extended capabilities in high-throughput PBPK calculations at the discovery/development interface, said David Miller , director of ADMET Cheminformatics at Simulations Plus.
Our software is used to conduct drug research by major pharmaceutical, biotechnology, chemical, consumer goods companies and regulatory agencies worldwide.

Simulations Plus Partners with Large Pharmaceutical Company to Enhance the Mechanistic Oral Absorption (ACAT) Model in GastroPlus

Retrieved on:

Thursday, November 14, 2019

Science, Software, Biotechnology, Research, Pharmaceutical, Health, Technology, Clinical trials, Health sciences, Pharmaceutical sciences, Health, Pharmacokinetics, Pharmacy, Simulation software, Simulations Plus, Physiologically based pharmacokinetic modelling, Biotechnology, Drug, Pharmaceutical industry

Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that it has entered into a new funded collaboration with a large pharmaceutical company to modify the mechanistic oral absorption (ACAT) model in GastroPlus to support gastrointestinal disease research.

Key Points:

Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that it has entered into a new funded collaboration with a large pharmaceutical company to modify the mechanistic oral absorption (ACAT) model in GastroPlus to support gastrointestinal disease research.
Working closely with our partners cross-functional team of DMPK, biopharmaceutics, and clinical pharmacology scientists, we intend to incorporate ground-breaking scientific approaches and validate the new methods using one-of-a-kind data collected by our partner.
John DiBella , Lancaster division president for Simulations Plus, added: Pharmaceutical companies have independently confirmed the GastroPlus physiologically based biopharmaceutics (PBBM) / physiologically based pharmacokinetic (PBPK) platform as the most accurate commercial tool available for predicting drug absorption following oral administration in animals and humans.
Our software is used to conduct drug research by major pharmaceutical, biotechnology, chemical, consumer goods companies and regulatory agencies worldwide.

Simulations Plus Partners with Large Pharmaceutical Company to Develop the Virtual Bioequivalence Trial Simulator™ Module

Retrieved on:

Thursday, October 17, 2019

Biotechnology, Health, Pharmaceutical, Technology, Software, Pharmacokinetics, Health sciences, Life sciences, Health, Simulations Plus, Physiologically based pharmacokinetic modelling, Bioequivalence, Biotechnology, Simulation, Modeling and simulation

Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that it has entered into a new funded collaboration with a large pharmaceutical company to develop the Virtual Bioequivalence (BE) Trial Simulator in GastroPlus.

Key Points:

Simulations Plus, Inc. (Nasdaq: SLP), the leading provider of modeling and simulation solutions for the pharmaceutical, biotechnology, chemicals, and consumer goods industries, today announced that it has entered into a new funded collaboration with a large pharmaceutical company to develop the Virtual Bioequivalence (BE) Trial Simulator in GastroPlus.
Working closely with our partners team of biopharmaceutics scientists, we intend to improve virtual BE trial simulation methodologies and efficiently address regulatory concerns as model results are reviewed.
It was evident that the use of PBBM / PBPK technology will significantly impact development and simplify regulatory decisions in a variety of ways.
Our software is used to conduct drug research by major pharmaceutical, biotechnology, chemical, consumer goods companies and regulatory agencies worldwide.

Simulations Plus Partners with Clinical-Stage Biotech Company to Develop Novel Dosing Models

Retrieved on:

Wednesday, September 4, 2019

Research, Technology, Software, Biotechnology, Pharmaceutical, Health, Science, Health sciences, Health, Simulation software, Life sciences, Simulations Plus, Physiologically based pharmacokinetic modelling, Pharmacokinetics, Simulation

We are very pleased to announce this collaboration, which will enhance the GastroPlus physiologically based biopharmaceutics (PBBM)/physiologically based pharmacokinetic (PBPK) model for drug dosing into joints through IA injection products, said Viera Lukacova , director of Simulation Sciences for Simulations Plus.

Key Points:

We are very pleased to announce this collaboration, which will enhance the GastroPlus physiologically based biopharmaceutics (PBBM)/physiologically based pharmacokinetic (PBPK) model for drug dosing into joints through IA injection products, said Viera Lukacova , director of Simulation Sciences for Simulations Plus.
John DiBella , Lancaster division president for Simulations Plus, added: These agreements help to extend the industry leading capabilities of our software tools, while at the same time increasing the investment that Simulations Plus contributes toward new research initiatives.
Also, similar to other collaborations which funded development of the numerous dosing models in the GastroPlus Additional Dosage Routes Module, Simulations Plus maintains the right to license the new functionality to all clients, creating additional revenue streams.
We look forward to continued interactions with our partners to drive advances to the GastroPlus platform and share the outcomes with the global scientific community.