Common Questions about Define-XML and the Stylesheet
In this blog, we answer common questions about Define-XML and the Stylesheet, including all you…
Certara2019 年 8 月 22 日
Trends for Market Access, HEOR, and Real World Evidence
This blog reviews trends for using health economics and outcomes research and real-world evidence to…
Certara2019 年 5 月 10 日
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
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
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
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
Overcoming Pitfalls and Challenges with Software Validation
As a quality consultant and quality system subject matter expert in the Life Sciences Industry…
Certara2018 年 6 月 29 日
Achieving Compliance with the FDA’s eCTD Mandate
The US Food and Drug Administration (FDA) has set 2018 年 5 月 5 日 as the compliance…
Certara2018 年 5 月 4 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
