Define.xml Frequently Asked Questions
Discover answers to common Define.xml FAQs, covering best practices, expert tips, and essential guidance for…
Certara2018年12月10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
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
The Many Challenges of Narrative Writing
Narratives are an essential part of any programs’ story, but often become cumbersome due to…
Certara2018年3月13日
Skin in the Game: Mechanistic Modeling of Dermal Drug Absorption
The ability to estimate systemic exposure from dermal absorption is essential in developing new dermatological…
Certara2018年3月2日
