The mechanistic translation of nonclinical pharmacokinetic data to humans can make or break the success of your clinical plan.
It’s critical to understand how to get the insight you need to determine…
What the clinical starting dose should be based on your nonclinical data
What doses will be included in your first-in-human (FIH) study
If you will achieve safety cover in nonclinical species
If your drug product will benefit from micronization
Whether you need to consider drug-drug interaction (DDI) studies
Other challenges that may need to be addressed in clinical development
In this webinar, Becky Graves, Director of Simulation Studies at Simulations Plus, will explain how to leverage the FIH Simulator to gain these insights and more. She’ll walk through physiologically based pharmacokinetic (PBPK) best practices, and how you can build PBPK models to translate nonclinical data to accurately design your FIH clinical trial and beyond.
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Can’t Miss
Upcoming Webinars
- Weight Loss Without Nausea: How QSP Modeling Can Optimize Obesity Treatments | Register
- Unlocking the Power of PBPK Modeling: PBPK for First-in-Human and Beyond | Register
- International Perspectives on Model-Informed Precision Dosing: From the Data to the Patients | Register
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Novice & Advanced Users
Workshops
- Advanced GastroPlus DMPK & Clinical Pharmacology Workshop (Virtual)
- PBPK Modeling for FIH Predictions: Virtual Workshop
-
Complimentary Introduction to GastroPlus Workshop
- GastroPlus Introductory Workshop
- Introductory and Advanced Pharmaceutical Development Workshop (Bundle)
- Mar. 11th-April 25th
- GastroPlus Application Based DDI Workshop
- Complimentary Introduction to GastroPlus Workshop
- GastroPlus Advanced Workshop: Pharmaceutical Development
In-Person
- Introductory GastroPlus Workshop: Mumbai, India
- PAGE Pre-conference Workshop: Introduction to GPX™
On-Demand Courses
- DILIsym® Crash Course On Demand
- Transdermal Administration (TCAT™) in GastroPlus®
- Injectables (IM, SQ, IA) in GastroPlus Including Biologics and LAIs
- Ocular Administration (OCAT™) in GastroPlus®
- Pulmonary Administration (PCAT™) in GastroPlus®
- GastroPlus® ADR – 4 Course Bundle (TCAT™ / OCAT™ / OCCAT™ / PCAT™)
- GastroPlus® ADR – 5 Course Bundle (TCAT™ / OCAT™ / OCCAT™ / PCAT™ / Injectables)
View Upcoming Workshops
Meet Us In Person
Conferences
PHUSE US Connect 2024: The Clinical Data Science Conference Feb. 25th-28th Bethesda, MD
- Presentation: An End User’s Perspective of Clinical Dosing Data Used for Population PK / PD Analysis with Non-Linear Mixed Effects Modeling Presenter: Rebecca Humphrey
MIDD+ Cambridge UK Feb. 29th -Mar.1st Cambridge, England, UKSOT 63rd Annual Meeting and ToxExpo Mar. 10th-14th Salt Lake City, UT
- Booth #1617
- Attendees: Brett Howell, Pallavi Bhargava, James Beaudoin, Francisco Huizar, Andrew Mueller, Michael Lawless
- Lunch & Learn “Next Generation of Simulations Plus Software Tools Enable Accurate Exposure & Safety Assessments” Mar. 11th from 12:00-1:00 PM MDT
AAPS 2024 NERDG Annual Meeting Mar. 22nd, Groton, CT
- Attendees: Dan O’Connor, Daniel Szot
ASCPT 2024 Annual Meeting Mar. 27th-29th, Colorado Springs, CO
- Presentation: Equity, Data, and Representation in Real-World Clinical Trials and Virtual Populations
- Presenters: Jeffrey Woodhead, Kyunghee Yang
- Attendees: Lisl Shoda, Lara Clemens, Steve Chang, Jeff Woodhead, Kyunghee Yang, Jill Fiedler-Kelly, Kelly Maxwell, Camila de Almeida, Tom Sun, Joy Yang, Revathi Chapa
- Simulations Plus After Hours Networking Event Mar. 28th, from 6:30-8:30 PM MDT
View Events Calendar
Take Advantage
Latest Offers
- Fully power your first-in-human predictions with our FIH Simulator. Learn more.
- Discover how you can use AI for early drug discovery. Start now.
- Get more out of consulting with Consult + Coach. Here’s how.
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Stay Informed
On Demand Webinars
- Using QST Predictions to Optimize Your Drug, De-Risk Your Regulatory Submission, and Guide R&D | Watch
- Capture and Use of Meaningful Data for Population PK/PD Analysis with Non-Linear Mixed Effects Modeling | Watch
- From Target Identification to Novel Lead: How Multi-omics Analysis and AI-driven Drug Design Can
- Accelerate Early Drug Discovery | Watch
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Stay Informed
Latest Research, Articles & Case Studies
- PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Metabolism in Pregnant Subjects and Fetuses | Read more
- Assessing the utility of in silico tools in early drug development: The case of a pharmaceutically relevant formulation of the prodrug psilocybin | Read more
- Use of the Same Model or Modeling Strategy Across Multiple Submissions: Focus on Complex Drug Products | Read more
- Preclinical characterization of the absorption and disposition of the brain penetrant PI3K/mTOR inhibitor paxalisib and prediction of its pharmacokinetics and efficacy in human | Read more
- Better bioavailability: The role of PBPK software predictions | Read more
- How to Select Your First-in-Human Modeling and Simulation Software Platform | Read more
- Identifying the Right Drug Dosage to Prevent DILI: How Astellas Used QST to Progress Fezolinetant to Phase 3 and Beyond | Read more
- Evaluating Hepatoxicity Before Late-Stage Trials: How Biohaven Used QST to Ensure Liver Safety and Gain Regulatory Approval | Read more
Read up on New Research
