Real World Evidence Marches Forward in Drug Development
The end of 2018 ushered in a flurry of new regulatory guidance and sponsor enthusiasm…
Certara2019 年 3 月 20 日
How to Perform IVIVC for Extremely Long Acting Drugs
Watch this webinar to learn how to use in vitro and in vivo models to…
Certara2019 年 2 月 22 日
Managing Immunogenicity Using Quantitative Systems Pharmacology
The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving…
Certara2019 年 2 月 22 日
PBPK’s Pivotal Role in Modern Drug Development: Busting Common Myths and Misconceptions
This white paper addresses common PBPK myths and misconceptions and demonstrates how this approach is…
Certara2019 年 2 月 4 日
7 Things to Know About the China Pharmaceutical Industry
China is the second largest pharmaceutical market in the world. Demand is likely to increase…
Certara2018 年 10 月 16 日
FDA’s New ANDA Submissions Guidance: Key Points
The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance…
Certara2018 年 9 月 27 日
How to Use a Reference-scaled Average Bioequivalence Approach for Narrow Therapeutic Index Drugs
Watch this webinar to learn how RSABE for NTIDs can be performed in Phoenix WinNonlin…
Certara2018 年 9 月 25 日
