Simcyp Simulator Impacts 80+ Novel Drugs Blog Post
250 Label claims using PBPK without the need for additional clinical studies “Clinical Studies and Model-Informed Approaches.” This is the language typically used by the US FDA on drug labels…
Controlled Terminology Best Practices Blog Post
Simplify Controlled Terminology with expert insights from Sarah Angelo. Overcome challenges, ensure compliance, and improve your submission process.
Certara Acquires AUTHOR!, a Regulatory and Biostatistics Services Firm in Europe Blog Post
Broadens European footprint with integrated regulatory services and statistical analysis PRINCETON, NJ.— 2021 年 3 月 2 日– Certara, Inc., a global leader in biosimulation, today announced the acquisition of AUTHOR!, a company...
The Importance of Continuity of Operations Plans for Gene Therapy Manufacturers Blog Post
By: James Zoshak The COVID-19 pandemic has added increased risk and uncertainty to gene therapy supply chains. To mitigate this risk, it is critical for biopharmaceutical manufacturers to properly maintain…
Why Consistency in Patient Safety Narratives is Crucial Blog Post
“You would not be able to tell 40 different writers were authoring these. It looked as though one person was writing them! The writers wrote a streamlined and visually-cohesive and…
8 Tips for Successfully Developing Oligonucleotide Therapies Blog Post
By Eva Gil Berglund and Nathalie H Gosselin Oligonucleotide therapeutics are a validated class of drugs that can modulate a multitude of genetic targets with gene silencing to prevent expression…
Regulatory submissions and transactions with Health Canada Blog Post
By Robert Labriola We’ve seen recent trends and activity with regards to pharmaceutical regulatory submissions to Health Canada. Several questions and queries have come into our regulatory operations department, and…
Preparing CDISC Submissions for China’s NMPA Blog Post
China’s NMPA now accepts CDISC submissions. To support this initiative, Pinnacle 21 has released a new Chinese-language validation engine.
PBPK modeling supports approval of breakthrough cancer drug Blog Post
Pharmacyclics’ (now AbbVie) Imbruvica (ibrutinib) is an anticancer drug targeting B-cell malignancies. Leveraging the US FDA’s accelerated approval programs, the company generated PBPK models using the Simcyp Simulator to inform…
