概要
With the evolution of in silico drug development, the reliance on animal testing for predicting human pharmacokinetics (PK) is undergoing a profound paradigm shift, one led by Certara through our Simcyp® and Applied Biosimulation technologies.
However, traditional allometric techniques still play a valuable role, offering efficient and precise estimates of human pharmacokinetics and dose prediction.
Unlike simple allometric scaling of clearance and volume, time-invariant pharmacokinetic (PK) scaling methods such as the Dedrick and Wajima approaches, describe the entire PK time-course, offering greater precision and confidence in predicting human pharmacokinetics than traditional parameter scaling.
Discover how these techniques, seamlessly integrated within the Phoenix® platform’s intuitive workflows, enhance translation from preclinical to clinical studies, streamline dose prediction, and improve first-in-human projections. With Phoenix’s trusted, regulatory-compliant environment and Certara’s deep translational and model-informed expertise, you’ll discover a proven path to faster, smarter, and more confident drug development decisions. Don’t miss this opportunity to refine your modeling toolkit and elevate your quantitative pharmacology strategy.
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Vice President, Clinical Pharmacology & Translational Medicine, Certara Drug Development Solution
Dr. Offmanは、20年以上にわたる医薬品開発の経験を有しています。2017年にサターラに入社し、サターラの臨床薬理＆トランスレーショナル・メディシングループでトランスレーショナル薬物動態および薬力学の業務を率いています。Dr. Offman has supported the development of several oncology products including Asparlas (calaspargase pegol), Oncaspar (pegasparaginase) and brigatinib (Alunbrig), and was instrumental in the approval of RedHill Biopharma’s Talicia for H. pylori infection. Prior to joining Certara, Dr. Offman was responsible for clinical pharmacology and pharmacometrics at Celerion, leading study design, data analysis and interpretation for clinical pharmacology studies including first-in-human, drug-drug interactions, mass balance and special population trials. Prior to joining Certara, Dr. Offman oversaw biopharmaceutics and scientific affairs for Genpharm, a subsidiary of Merck KGaA as well as Mylan. Additionally, as a clinical pharmacologist, Dr. Offman has supported development and approval of Epanova (Omthera), XHANCE (Optinose) and Austedo (Auspex).
Dr. Offman obtained a PhD at the University of Waterloo (Waterloo, Canada) in model-based drug development with a particular focus in physiologically and population based pharmacokinetic modelling of subcutaneously administered large molecules. Dr. Offman is a licensed pharmacist and completed a residency in clinical pharmacy at the London Healthy Sciences Centre (Ontario, Canada) and a MSc in Clinical Pharmacology from Western University in Ontario, Canada. Dr. Offman is a holder of a patent and has co-authored over 50 abstracts and peer-reviewed manuscripts.
Director, Clinical Pharmacology and Translational Medicine, Certara
Dr. Racheal Kendrick is currently a Director of Clinical Pharmacology and Translational Medicine at Certara. She has 15 years of drug development experience with a focus on quantitative solutions using state of the art methods and software. Racheal has contributed to all phases of the drug development cycle including first in human dose selection, IND support, Phase I study design, strategy, and implementation, dose-finding approaches, exposure-response analyses, and regulatory interactions. Racheal has experience collaborating with teams of scientific professionals from some of the worlds major pharmaceutical and biotechnology companies in many therapeutic areas including neurology, ophthalmology, infectious disease, oncology, hematology, and contraception, advancing both large and small molecules.
Prior to her role at Certara, Racheal was an associate director at a contract research organization, with a focus on Phase I studies. Racheal received her Doctor of Pharmacy from the University of Missouri-Kansas City and completed a pharmacokinetics and pharmacodynamics fellowship with the University of North Carolina and Quintiles.
Product Manager, Phoenix
Christopher Mehl is the Product Manager for Phoenix, after spending the last several years as an Instructor at Certara University. His educational background is a BS in Molecular Biology from the Ohio State University, and an MS in Pharmacology from the University of Wisconsin. He has conducted over 200 training courses with Certara products such as Phoenix WinNonlin, IVIVC, NLME, PK Submit, and Trial Simulator. 指導経験は米国食品医薬品局、大学、顧客拠点でのワークショップおよび公開講座を含みます。In his current role, Chris manages customer success with Phoenix Hosted and cloud-based software offerings.
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