• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Mitsubishi Tanabe joins Certara’s Simcyp Consortium

Mitsubishi Tanabe joins Certara’s Simcyp Consortium

July 20, 2016
CenterWatch Staff

Certara, a provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, has announced that Mitsubishi Tanabe joined its Simcyp Consortium and licensed its proprietary Simcyp Population-based Simulator.

Mitsubishi Tanabe is the 34th biopharmaceutical company and the 10th Japanese pharmaceutical company to join the Consortium. In addition to its biopharmaceutical industry members, academic institutions from around the globe, and key regulatory bodies, including the FDA, the EMA, and Japanese Pharmaceuticals and Medical Devices Agency are affiliates of the Simcyp Consortium.

“We are thrilled to have Mitsubishi Tanabe as a member of the Simcyp Consortium,” said Stephen Toon, BPharm, Ph.D., president and managing director of Certara’s Simcyp division. “Membership provides numerous benefits, including the opportunity to share knowledge and collaborate in the development of best practices and cutting-edge science for studying drug activity in virtual patients. In addition to creating annual updates to the Simcyp Simulator, Simcyp has also produced models for pediatric, pregnant, obese, hepatic- and renally-impaired populations. These advances have enabled member companies to evaluate new therapies in patient groups and clinical scenarios that might have historically been considered ‘untestable.’”

The Simcyp Consortium was formed in 2001 to serve as a collaborative research center for physiologically-based pharmacokinetics (PBPK) and mechanistic modeling. Since that time, Simcyp has established itself as the vanguard of PBPK and mechanistic modeling and simulation sciences and the Simcyp Simulator has evolved to become the most sophisticated platform for the prediction of pharmacokinetic outcomes in virtual patient populations. The Simulator provides valuable information, which informs key management decisions relating to clinical trial design, the need for specific clinical trials, formulation design, dosing in special populations, and drug-drug interactions (DDIs). The Simulator is also used to identify key preclinical data requirements, which can prove extremely valuable for redefining and optimizing early drug development processes and procedures.

Over the past few years, use of the Simcyp Simulator has been leveraged to inform more than 100 label claims for new drug and biologic approvals from FDA. These label additions include potential DDIs, formulation recommendations, dosing regimens, and data about new populations.

Upcoming Events

  • 12Apr

    The Patient Playbook Webinar Series, Part 3 — Rethinking the Development of Participant-Centric Clinical Trial Technology

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Five Ws

    Consider the Five ‘W’s to Understand Potential Participants

  • QandA-360x240.png

    Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

  • White House

    Trial Stakeholders Advise White House on Emergency Research Infrastructure

  • SurveywBlueBackground-360x240.png

    Stress Levels Continue to Climb in Healthcare Workforce, Survey Finds

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing