Dr. Mark Lovern will provide an overview of recent drug development market and regulatory trends regarding adoption and acceptance of physiologically-based pharmacokinetic (PBPK) approaches, and how these challenges are being addressed by new features in v22 of the Simcyp Simulator.
Simcyp led a panel discussion on the benefits of using physiologically-based pharmacokinetic modeling & simulation for 2 vulnerable populations—pregnancy and pediatrics.
Drug developers often rush through the discovery process to get into human testing. Most are so curious about their new target or molecule that they may forget that the pharmaceutical formulation process that can easily make or break their program. Once in human testing, revisiting these formulations is often time-consuming. By then, depending on drug … Continued
One of the pivotal milestones of early drug development is obtaining approval for an investigational new drug application (IND). A proposed first-in-human (FIH) study design is required for every IND application, of which a robust FIH dose rationale is a critical component. Physiologically-based pharmacokinetic (PBPK) modeling is a methodology based upon in-depth mechanistic understanding of … Continued
Tailored for discovery and translational scientists, Simcyp Discovery Simulator is an intuitive software that delivers confidence in decision-making during the pre-Investigational New Drug (IND) application and translational development. Simcyp Discovery is based on physiologically-based pharmacokinetic (PBPK) modeling and simulation, a regulatory-adopted, versatile tool in drug development that helps answer a myriad of “what if” questions … Continued
Represents Fourth FDA Grant for Simcyp MechDermA Model for Virtual Bioequivalence PRINCETON, N.J.— 2021 年 9 月 20 日. Certara (Nasdaq: CERT), a global leader in biosimulation, today announced the Company has been awarded a grant from the U.S. Food and Drug Administration (FDA) to verify and expand biosimulation models for assessing virtual bioequivalence (VBE) to help enable … Continued
How can the latest modeling and simulation technologies accelerate drug discovery and development? We frequently receive questions about why model-informed drug development (MIDD) is so critical to informing the development of safer and more effective new drugs? Indeed, all drug discovery and development today involves some level of MIDD, a term that encompasses a large … Continued
PRINCETON, NJ – 2021 年 8 月 26 日 – Certara, a global leader in biosimulation, today announced that its Simcyp COVID-19 Vaccine Model has been named a finalist in both Informa Pharma Intelligence’s 2021 Citeline Awards in the Excellence in Innovation in Response to COVID-19 – Clinical Trial Activities category and R&D World’s 2021 R&D 100 Awards … Continued
This webinar was presented on 2021 年 6 月 30 日 by David R. Taft, Ph.D. Professor, Pharmaceutics, Long Island University, NY, USA. Here is a summary of his presentation: • Tizanidine is an alpha2-adrenergic agonist, used to treat spasticity associated with multiple sclerosis and spinal injury. Tizanidine is primarily metabolized by CYP1A2 and is considered a sensitive … Continued
The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing the Flame of a Healthy Debate” published in ASCPT’s CPT Pharmacometrics & Systems Pharmacology exposes the different perspectives around origin, use and ongoing advancement of modeling & simulation software for regulatory purposes. Concepts of quality, data reproducibility, model qualification (model … Continued
