Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study Blog Post
In this case study, the sponsor’s closing of a manufacturing site required that one of its top-selling products be made at a different facility, triggering FDA to request they demonstrate...
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Blog Post
Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare B-cell malignancies to market. The company leveraged FDA’s accelerated approval program; it was one of...
PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking Blog Post
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…
Why You Should Participate in the Voluntary FDA Oncology Center of Excellence Assessment Aid Program Blog Post
In 2018, the FDA’s Oncology Center of Excellence developed an Assessment Aid document to help facilitate review of New Drug Applications (NDAs)/Biologics License Applications (BLAs) (including supplements) submitted to the…
Raj’s Corner: Blog Roundup Page
Raj 专栏：Blog Roundup Raj’s corner: Expert strategies for streamlined drug development Explore expert blog posts from Dr. Rajesh Krishna, Certara’s Senior Distinguished Scientist, on best practices for optimizing clinical...
Strategic Planning and technology to support a rolling BLA submission under tight timelines Blog Post
一家 3 级申办方委托 Certara 支持其滚动式 BLA 提交，这是我们在整体合作中为该申办方支持的第二次提交。The agile nature of the...
Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate Blog Post
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…
