External Control Arms – The Case for a Standardized Lexicon and Toolkit
Both the FDA and EMA have made statements that support the concept of using real…
Jim Gallagher2021年10月12日
Model-based DDI Extrapolation Strategy from Adults to Children – A Case Study with Risdiplam
Risdiplam (EVRYSDI) is approved for the treatment of patients with spinal muscular atrophy ≥ 2…
Jim Gallagher2021年10月7日
FDA’s Digital Transformation: The Future of Technology and How to Prepare
As Life-Science manufacturers embrace new technologies to speed time to market and products become more…
Jim Gallagher2021年10月5日
The Scary Future of Rare Disease Management
In a world of rising healthcare costs, the greatest nightmare for payers is reimbursing drug…
Jim Gallagher2021年9月23日
バイオ医薬品における臨床薬理計画の全体像とは？
Monoclonal antibodies are now widely used in the treatment of several diseases, providing effective and…
Jim Gallagher2021年8月6日
PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking
This webinar was presented on 2021年6月30日 by David R. Taft, Ph.D. Professor, Pharmaceutics,…
Jim Gallagher2021年7月26日
Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate
The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing…
Jim Gallagher2021年7月15日
Three Pathways have emerged in Innovative Access Agreements
The days of simply determining the market demand for a new drug as a function…
Jim Gallagher2021年6月11日
Outcomes Based Agreements
The days of simply determining the market demand for a new drug as a function…
Jim Gallagher2021年6月11日
De-risk your program with evidence-based secondary pharmacology insights
Safety issues account for about a quarter of the attrition in drug projects and can…
Jim Gallagher2021年5月28日
