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Biosimulation is quantitative drug development, also known as modeling
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Overcome the challenges to demonstrating and delivering value effectively
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Improve discovery research data utilization and optimize
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The industry gold-standard for pharmacokinetic / pharmacodynamic (PK/PD)
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User-friendly and powerful nonlinear mixed effect modeling software
* Phoenix™ IVIVC Toolkit
Enhanced tools for in vitro-in vivo correlation studies to accelerate
your drug development
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Create complete pharmacokinetic (PK) regulatory submission-ready CDISC
domains in minutes
* Phoenix Hosted
Phoenix platform and Integral repository paired together for an
end-to-end PK/PD validated SaaS offering in the cloud
* Pinnacle 21 Enterprise CDISC Software
* Pinnacle 21
Validate clinical trial data for biosimulation and regulatory submission
* Simcyp™ Mechanistic Modeling
* Simcyp™ PBPK Simulator
Simcyp PBPK models describe the behavior of drugs in different body
tissues, with each tissue considered a physiological compartment
* Simcyp™ Discovery
Versatile tool for translational modeling and simulation
* Simcyp™ Secondary Intelligence
De-risk your program with evidence-based secondary pharmacology insights
* Simcyp™ Quantitative Systems Pharmacology Platform
Predict Clinical Outcomes for Novel Targets, Modalities & Combinations
* Simcyp Biopharm
Streamline the identification and refinement of promising formulations in
a cost-effective manner
* D360™ Scientific Informatics Software
* D360
Shorten the drug discovery design-make-test-analyze cycle with D360’s
self service data and analytics
* Certara.AI Platform
* Certara.AI Platform
Solve data silo problems while improving analytics capabilities that
drive productivity and accelerated data discovery across life science R&D
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Empower complex decisions to streamline your path to approval with
Certara’s leading quantitative analysis and predictive modeling
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Achieve maximum value with expert support to extract insights from your
biological data
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We work alongside your team to inform critical decisions and set you up
for regulatory and commercial success
* Regulatory Services and Medical Communications
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Deliver successful submission documents on time, every time
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Having the right regulatory strategy in place will save time and money,
and may result in the acceleration of your drug development program
* Regulatory Operations
Accelerate submission success with customized scalable solutions
* Scientific and Medical Communications and Publications
Increase exposure of your key findings with expert planning and writing
support
* Medical Technology
Advance regulatory approvals for your medical devices and diagnostics
* Transparency and Disclosure
Enhance patient engagement and maintain compliance with data
anonymization solutions
* Safety and Pharmacovigilance
Achieve compliance with an integrated team for your safety and PV
document needs
* Submission Leadership
Protect your submission with comprehensive support from a proven team of
experts
* Real World Evidence and Market Access Consulting
* Real World Data Solutions
Our real world data solutions allow for niche needs identification,
justifying access, differentiating value, quantifying an opportunity an
demonstrating benefit/risk of your product
* Decision Analytics and Modeling
Determine your products value with our best in class capabilities in
modeling, simulation, mathematics & Bayesian statistics paired with
advanced analytics frameworks & proprietary software
* Health Economics and Outcomes Research (HEOR)
Showcase the real-world value of your product
* Market Access and Pricing
Optimal drug pricing and reimbursment strategy
* US and EU Payer Engagement
Implement your payer engagment strategy early and often for optimal
reimbursment
* Value and Strategy
Optimize your product value, positioning and evidence synthesis across
all stages of the reimbursement journey
* Specialty Areas
* Cell and Gene Therapy
Derisk and accelerate the development of your cell and gene
therapies–from discovery to market access–through an integrated approach
and unmatched expertise
* Pediatrics
Tackle pediatric drug development challenges head on to ensure safe and
effective medicines to children with our team of multidisciplinary
experts
* Oncology
Trust the experts who advanced 500+ oncology projects in 2021
* Rare Disease and Orphan Drug
Overcome the unique challenges in rare disease and orphan drug
development through an integrated approach to modeling and simulation
* Complex Biologics
Maximize program efficiencies and increase the likelihood of regulatory
success with Certara’s unmatched experience and expertise in complex
biologics
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Certara is committed to understanding, monitoring, and managing our
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Many global regulatory agencies have adopted use of Certara’s Simcyp PBPK
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* Articles
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* Publications
Research authored by scientists at Certara
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interactive webinars
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science trends on your time
* Conferences
Connect with us during industry events at our booth or during our thought
leadership presentations
* Knowledge Base
See how our experts have answered questions throughout the years
* Podcast
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trends
* Success Stories
Explore our curated selections of thought-provoking blogs, white papers,
case studies, and webinars
* Scientific Awards
From award winning innovation to some of the top scientist in the world
we are proud to be accelerating medicines together.
* Support
* Training
* Certara University
Explore on demand, live, and in-person PK/PD courses taught using Certara
software Phoenix WinNonlin
* Professional Certification
Demonstrate your PK/PD expertise by obtaining a Certara Professional
Certification
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Get a solid grounding in mechanistic modeling and simulation
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* Software
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View All
* By Category
* Biosimulation
Biosimulation is quantitative drug development, also known as modeling
and simulation.
* Data Science
Visualize clinical and non clinical data to improve drug development
decisions
* Regulatory
Increase efficiency for your regulatory preparation and submission
process
* Market Access
Overcome the challenges to demonstrating and delivering value effectively
* Discovery Informatics
Improve discovery research data utilization and optimize
design-make-test-analyze cycles
* Data Innovation
Advanced Deep Learning Analytics and AI
* Phoenix™ PK/PD Platform
* Phoenix WinNonlin™
The industry gold-standard for pharmacokinetic / pharmacodynamic (PK/PD)
analysis
* Phoenix NLME™
User-friendly and powerful nonlinear mixed effect modeling software
* Phoenix™ IVIVC Toolkit
Enhanced tools for in vitro-in vivo correlation studies to accelerate
your drug development
* PK Submit™
Create complete pharmacokinetic (PK) regulatory submission-ready CDISC
domains in minutes
* Phoenix Hosted
Phoenix platform and Integral repository paired together for an
end-to-end PK/PD validated SaaS offering in the cloud
* Pinnacle 21 Enterprise CDISC Software
* Pinnacle 21
Validate clinical trial data for biosimulation and regulatory submission
* Simcyp™ Mechanistic Modeling
* Simcyp™ PBPK Simulator
Simcyp PBPK models describe the behavior of drugs in different body
tissues, with each tissue considered a physiological compartment
* Simcyp™ Discovery
Versatile tool for translational modeling and simulation
* Simcyp™ Secondary Intelligence
De-risk your program with evidence-based secondary pharmacology insights
* Simcyp™ Quantitative Systems Pharmacology Platform
Predict Clinical Outcomes for Novel Targets, Modalities & Combinations
* Simcyp Biopharm
Streamline the identification and refinement of promising formulations in
a cost-effective manner
* D360™ Scientific Informatics Software
* D360
Shorten the drug discovery design-make-test-analyze cycle with D360’s
self service data and analytics
* Certara.AI Platform
* Certara.AI Platform
Solve data silo problems while improving analytics capabilities that
drive productivity and accelerated data discovery across life science R&D
* View All
* Software
Software to inform key safety, efficacy and efficiency decisions
throughout the entire development process
* Services
* Services
View All
* Model-informed Drug Development
* Modeling and Simulation Services
Empower complex decisions to streamline your path to approval with
Certara’s leading quantitative analysis and predictive modeling
* Biometrics and Data Sciences
Achieve maximum value with expert support to extract insights from your
biological data
* Drug Development Services
We work alongside your team to inform critical decisions and set you up
for regulatory and commercial success
* Regulatory Services and Medical Communications
* Medical Writing
Deliver successful submission documents on time, every time
* Regulatory Consulting and Regulatory Affairs
Having the right regulatory strategy in place will save time and money,
and may result in the acceleration of your drug development program
* Regulatory Operations
Accelerate submission success with customized scalable solutions
* Scientific and Medical Communications and Publications
Increase exposure of your key findings with expert planning and writing
support
* Medical Technology
Advance regulatory approvals for your medical devices and diagnostics
* Transparency and Disclosure
Enhance patient engagement and maintain compliance with data
anonymization solutions
* Safety and Pharmacovigilance
Achieve compliance with an integrated team for your safety and PV
document needs
* Submission Leadership
Protect your submission with comprehensive support from a proven team of
experts
* Real World Evidence and Market Access Consulting
* Real World Data Solutions
Our real world data solutions allow for niche needs identification,
justifying access, differentiating value, quantifying an opportunity an
demonstrating benefit/risk of your product
* Decision Analytics and Modeling
Determine your products value with our best in class capabilities in
modeling, simulation, mathematics & Bayesian statistics paired with
advanced analytics frameworks & proprietary software
* Health Economics and Outcomes Research (HEOR)
Showcase the real-world value of your product
* Market Access and Pricing
Optimal drug pricing and reimbursment strategy
* US and EU Payer Engagement
Implement your payer engagment strategy early and often for optimal
reimbursment
* Value and Strategy
Optimize your product value, positioning and evidence synthesis across
all stages of the reimbursement journey
* Specialty Areas
* Cell and Gene Therapy
Derisk and accelerate the development of your cell and gene
therapies–from discovery to market access–through an integrated approach
and unmatched expertise
* Pediatrics
Tackle pediatric drug development challenges head on to ensure safe and
effective medicines to children with our team of multidisciplinary
experts
* Oncology
Trust the experts who advanced 500+ oncology projects in 2021
* Rare Disease and Orphan Drug
Overcome the unique challenges in rare disease and orphan drug
development through an integrated approach to modeling and simulation
* Complex Biologics
Maximize program efficiencies and increase the likelihood of regulatory
success with Certara’s unmatched experience and expertise in complex
biologics
* About Us
* About Us
Our Story
* Why Certara
* Responsibility
Certara is committed to understanding, monitoring, and managing our
social and environmental responsibilities.
* Regulatory Adoption
Many global regulatory agencies have adopted use of Certara’s Simcyp PBPK
and Phoenix PK/PD platforms
* Locations
Discover our global office locations
* Leadership
Meet our Executive Team and Board of Directors
* Partnerships
Our Centers of Excellence, Technology Partners, & Software Global
Distribution Partners
* Careers
* Careers at Certara
Explore what sets us apart
* Browse Jobs
Search Certara openings by global region
* Locations
Discover our global office locations
* Investors
* News
* Privacy and Legal
* Terms of Use
As a visitor to Certara.com users can view the terms and conditions of
this site.
* Privacy Center
Our Privacy Center makes it easy to see how we collect and use your
information
* Code of Conduct
Our Certara Code of Conduct ensures that we hold ourselves and our
business practices to a high standard, allowing us to fulfill our
obligations to the many stakeholders we serve.
* Resources
* Resources
View All
* Scientific Content
* Case Studies
Learn how we helped solve our client’s drug development challenges
* White Papers
Read our experts’ thoughts on the latest industry & regulatory trends
* Blogs
Our blogs examine key issues in biosimulation and regulatory science
* Articles
Bylines and contributions from Certara’s thought leaders
* Publications
Research authored by scientists at Certara
* Webinars
Catch up on the latest trends & best practices during our educational,
interactive webinars
* On Demand Webinars
Stay on the cutting edge of model-informed drug development & regulatory
science trends on your time
* Conferences
Connect with us during industry events at our booth or during our thought
leadership presentations
* Knowledge Base
See how our experts have answered questions throughout the years
* Podcast
Listen to our experts discuss drug discovery and development topics and
trends
* Success Stories
Explore our curated selections of thought-provoking blogs, white papers,
case studies, and webinars
* Scientific Awards
From award winning innovation to some of the top scientist in the world
we are proud to be accelerating medicines together.
* Support
* Training
* Certara University
Explore on demand, live, and in-person PK/PD courses taught using Certara
software Phoenix WinNonlin
* Professional Certification
Demonstrate your PK/PD expertise by obtaining a Certara Professional
Certification
* Simcyp Workshops
Get a solid grounding in mechanistic modeling and simulation
* View All
* Careers
* Careers at Certara
Explore what sets us apart
* Browse Careers
Search Certara openings by global region
* Locations
Discover our global office locations
* PLACEHOLDER
* PLACEHOLDER
* Careers
* Careers
* Careers at Certara
* Careers at Certara
Explore what sets us apart
* Browse Jobs
Search Certara openings by global region
* Employment Awards
Certara is honored to be recognized by employees and organizations as a
top place to work
* Scientific Awards
From award winning innovation to some of the top scientist in the world
we are proud to be accelerating medicines together.
* Locations
Discover our global office locations
* PLACEHOLDER
* PLACEHOLDER
Contact Us
LIVE WEBINAR
AAPS ECHALK TALK: FDA MODERNIZATION ACT – WHAT DOES IT MEAN FOR PHARMACEUTICAL
SCIENTISTS?
Register Today!
Wednesday, September 13 2023 11:15am (ET)
REALIZING
WHAT’S POSSIBLE.
A brighter, healthier future for all is possible through modern medicine. But
success in drug discovery and development is never guaranteed. At Certara, our
human and technological expertise allows us to anticipate risks and guide
decision making to push new ideas forward and revolutionize patient care.
What’s possible for your program with Certara?
Learn HOW CERTARA CAN HELP YOU
90% of new drug approvals by the FDA were received by our customers in the last
9 years
300+ global regulatory and health authority submissions were prepared and
delivered in the past 5 years
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TECH-ENABLED SERVICES
UNMATCHED EXPERIENCE AND EXPERTISE
Our drug-development consultation services reflect decades of experience from
more than 650 healthcare and pharmaceutical professionals, as well as
leading-edge technological solutions. This combination delivers the insights and
knowledge to accelerate regulatory and commercial success while saving time and
money. Over the last decade, we have worked on more than 7,000 customer
projects, across practice areas and drug development phases, leading to the
extensive experience our customers highly value.
EXPLORE SERVICES
PROPRIETARY SOFTWARE
LEADING THE INDUSTRY IN DRUG DISCOVERY AND DEVELOPMENT
Our quantitative approach to model-informed drug development offers a
comprehensive view of the clinical and regulatory possibilities and challenges
facing new therapies. We derive significant insights that inform the
development of our biosimulation software. These insights help us to anticipate
and align our technology roadmap with our customers’ needs and priorities. By
providing the clearest picture of both opportunities and risks in the
development lifecycle, we remove doubt and inspire confidence at key milestones
during the process.
BROWSE SOFTWARE
PINNACLE 21 REGULATORY CDISC COMPLIANCE SOFTWARE
The data management and compliance solution for data needs: speccing, mapping,
cleaning, checking, comparing, transforming, converting.
Learn More
PHOENIX PHARMACOKINETIC / PHARMACODYNAMIC PLATFORM
The global leader in software for preparing clinical trial data for regulatory
submission.
Learn More
SIMCYP PHYSIOLOGICALLY BASED PHARMACOKINETIC (PBPK)
Simcyp PBPK models describe the behavior of drugs in different body tissues,
with each tissue considered a physiological compartment.
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SCIENTIFIC CONTENT
TRANSFORMING THE FUTURE OF DRUG DEVELOPMENT
Our goal is to not only push the boundaries of what’s possible through medical
therapies and devices, but also to challenge the thinking that drives regulatory
science. We are committed to sharing our thought leaders’ insights and findings
to question current approaches and envision what the future holds for
biosimulation and public health.
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01
AAPS ECHALK TALK: FDA MODERNIZATION ACT – WHAT DOES IT MEAN FOR PHARMACEUTICAL
SCIENTISTS?
September 13, 2023
Historically, the FDA has required drug discovery and development programs
to include animal testing. With the 2022 passage of the FDA Modernization
Act 2.0, the definition of “nonclinical tests” conducted to support
pharmaceutical development has been broadened to include adjunct
and complementary testing methods. In this webinar with Certara’s Dr. Jim
Herman, he will discuss how scientists can use innovative, … <a
href="https://www.certara.com/webinar/aaps-echalk-talk-fda-modernization-act-what-does-it-mean-for-pharmaceutical-scientists/">Continued</a>
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02
RAPS SPONSORED WEBCAST: HOW TO PLAN FOR A SUCCESSFUL EMA POLICY 0070 SUBMISSION
September 14, 2023
In September 2023, the European Medicines Agency (EMA) will reinstate their
Policy 0070 requirement to publish all clinical studies submitted to the EMA for
regulatory approval. After almost five years of being offline (other than for
COVID-19 submissions), the process and new standards that go along with Policy
0070 will likely be new to many … <a
href="https://www.certara.com/webinar/raps-sponsored-webcast-how-to-plan-for-a-successful-ema-policy-0070-submission/">Continued</a>
Read More
03
IRA IMPACTS: FIRST 10 DRUGS SELECTED FOR THE DRUG PRICE NEGOTIATION PROGRAM
September 19, 2023
The Inflation Reduction Act (enacted in August 2022) contains profound changes
for the healthcare and pharmaceutical industries, shifting responsibility for
drug costs away from beneficiaries and onto plans and manufacturers. The law
affects provider reimbursement, changes AMP and ASP calculations, and, perhaps
most significantly, allows the federal government to negotiate prices for the
first time—all … <a
href="https://www.certara.com/webinar/ira-impacts-first-10-drugs-selected-for-the-drug-price-negotiation-program/">Continued</a>
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01
2023 ACCP ANNUAL MEETING
September 10, 2023
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02
25TH NORTH AMERICAN ISSX MEETING
September 10, 2023
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03
RAPS CONVERGENCE 2023
October 03, 2023
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01
ICER’s Unsupported Price Increase Report: Unfit for Policymaking July 25, 2023
Since 2019, the Institute for Clinical and Economic Review (ICER) has published
an annual Unsupported Price Increase (UPI) Report on its “assessment on drugs
that experience significant price hikes without any novel clinical evidence” to
guide policy making on prescription drugs. US lawmakers have shown interest in
the UPI approach as a potential tool to … Continued
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02
Understanding the Impact of FDA Modernization Act 2.0 on Drug Development July
6, 2023
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03
Simcyp™ PBPK for Drug-Drug Interactions (DDI): Inform, Reduce, Eliminate
Clinical Studies May 31, 2023
Read More
01
AAIC 2023 Reflections: Advancements in Alzheimer’s Disease Drug Research August
31, 2023
The recent Alzheimer’s Association International Conference (AAIC) meeting was a
testament to the thriving landscape of Alzheimer’s research, drawing over 7,000
in-person and 4,000 virtual attendees. One standout moment was the presentation
of a successful Phase 3 trial for Donanemab, an amyloid beta targeting antibody,
which was hailed as a “historic watershed” in the field. … Continued
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02
Payers’ reaction to the IRA’s Medicare Part D Redesign August 25, 2023
On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022
(IRA) into law. One key objective of the IRA is to shift healthcare costs from
patients and the Centers for Medicare & Medicaid Services (CMS) to health
insurers and pharmaceutical manufacturers. While the provisions allowing CMS to
negotiate drug prices for select … Continued
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03
Stop if you don’t have an unambiguous drug effect for your new molecular entity!
August 18, 2023
As a pharmacologist, I’ve always been curious about how drugs work. A favorite
time-killer while waiting at a doctor’s office is reading drug labels (also
known as package inserts) contained within the pages of “lifestyle” magazines.
Ever wonder what a package insert looks like? Ask a pharmacist. By law,
pharmacies are supposed to offer that … Continued
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YOUR TRUSTED PARTNER FOR KEY DECISION POINTS
“Certara’s contribution to the drug development program for Nurtec ODT was
substantial. Their clinical pharmacology representative worked seamlessly with
the Biohaven Development Team. Certara’s considerable expertise in clinical
pharmacology and pharmacometrics and flawless execution supported Nurtec’s
clinical development team and helped to prepare the clinical pharmacology NDA
components.” Richard Bertz, PhDVice President, Clinical Pharmacology &
Pharmacometrics
“Working with Synchrogenix [Certara Regulatory] was the next best thing to
having a fully staffed and seasoned RegOps team on site.” Vice President of
Regulatory Affairs | Gritstone Oncology
“D360 is saving us hundreds of hours annually on data analysis. That is an
important contribution to our research. The Certara team is tenacious and
resourceful. They always find a solution. That’s what has made our relationship
so successful.” Dr. Keith Hornberger, Director of Chemistry, Arvinas
01
Leveraging Pharmacokinetic Modeling & Scientific Communications Expertise
Advances Sarcoidosis Drug Program
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02
Translational Pharmacology Consulting Supports Combination Therapy for Treating
Pulmonary Mycobacterium Avium Complex Disease
Pulmonary non-tuberculous mycobacteria (NTM) is a debilitating disease that can
lead to reduced lung function and decreased quality of life. The prevalence of
NTM infections has been increasing in recent years, particularly in developed
countries.1 It is caused by bacteria belonging to the genus Mycobacterium with
approximately 80% of NTM infections caused by Mycobacterium avium … Continued
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03
Using MBMA to run virtual “head-to-head trials”
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FEATURED CASE STUDIES
SUCCESS IS ACHIEVED TOGETHER
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expensive and time-consuming part of drug development. In some cases, we can
eliminate certain human trials completely. More than 2,000 customers worldwide
choose us as their partner for biosimulation software and technology-driven
services. See how we have helped companies like yours redefine what’s possible
for safe and effective modern medicine.
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