Month: February 2018
Estimating the Number of Transit Compartments Using a Distributed Delay Model
Watch this webinar to learn how the delay operator implemented in Phoenix 8 can eliminate the need to add complex lines of code for each delay differential equation, simplify modeling delayed outcomes, and avoid inefficient workarounds and approximations.
A Randomized, Controlled Trial Evaluating the Efficacy and Safety of BTH1677 in Combination with Bevacizumab, Carboplatin, and Paclitaxel in First-line Treatment of Advanced Non-small Cell Lung Cancer
Certara Demonstrates Proof of Concept for its Virtual Twin™ Technology
PRINCETON, NJ – Feb. 27, 2018 – Certara today announced that it has published two papers demonstrating proof of concept for its Virtual Twin™ technology.
Incorporation of GSTA1 Genetic Variations into a Population Pharmacokinetic Model for IV Busulfan in Pediatric Hematopoietic Stem Cell Transplantation
How to Plan and Implement a Pharmacology to Payer Framework
Pharmacology to the payer (P2P) is an innovative approach to create a framework for dialogue between drug sponsors, regulators, and payers. The core structure is the sequential linking of quantitative mathematical models—pharmacology, pharmacokinetics/pharmacodynamics (PK/PD), disease progression, epidemiology, health utilization, and health economics. In this blog post, we discuss how working with an amazing team of … Continued
Apocalyptic Clinical Pharmacology: A Comprehensive Approach to Drug Development
Watch this webinar with Dr. Graham Scott, Senior Director of Clinical Pharmacology at Certara Strategic Consulting, to learn why you should invest in “apocalyptic clinical pharmacology.” Dr. Scott presented case studies that illustrate how sponsors can benefit from a clinical pharmacology strategy that uses model-informed approaches to inform and “fill in the gaps” of clinical trials.
DIA’s RSIDM Ask The Regulators Session: What We Learned
DIA’s Annual Regulatory Submissions, Information, and Document Management (RSIDM) Meeting is an excellent opportunity to learn the latest eCTD information and best practices. One of the most valuable sessions of the meeting is always the “Ask the Regulators” session, in which representatives from FDA answer questions directly from the attendees. This year, DIA scheduled two … Continued
Surveying the Lay of the Land for Modeling & Simulation for Global Regulatory Submissions
Analogous to how a geologist surveys the “lay of the land” to determine if oil lies underneath, or an investment advisor strives to understand the “lay of the land” to decide how to invest in a turbulent market, sponsors and regulators also need to determine how to best utilize and report modeling and simulation results … Continued