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
