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
