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
Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success
Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an…
Certara2021年7月8日
8 Tips for Successfully Developing Oligonucleotide Therapies
By Eva Gil Berglund and Nathalie H Gosselin Oligonucleotide therapeutics are a validated class of…
Certara2021年2月1日
“Where do I start?”: Strategies for selecting the first dose for human clinical trials
This guide to dose selection for first-in-human studies explains the conceptual framework, methods, and tools…
Jim Gallagher2020年12月22日
Clinical Pharmacology Gap Analysis: Lessons Learned
Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these…
Certara2018年8月10日
Using M&S to Evaluate Oncology Drug Dosing
There are numerous challenges in developing oncology drugs: (1) they are often very toxic which…
Certara2018年4月13日
Using a Pharmacology to Payer Framework to Support Product Development
Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains…
Certara2018年3月16日
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…
Certara2018年2月16日
