Define.xml Frequently Asked Questions
Discover answers to common Define.xml FAQs, covering best practices, expert tips, and essential guidance for…
CertaraDecember 10, 2018
7 Things to Know About the China Pharmaceutical Industry
China is the second largest pharmaceutical market in the world. Demand is likely to increase…
CertaraOctober 16, 2018
FDA’s New ANDA Submissions Guidance: Key Points
The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance…
CertaraSeptember 27, 2018
Clinical Pharmacology Gap Analysis: Lessons Learned
Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these…
CertaraAugust 10, 2018
Overcoming Pitfalls and Challenges with Software Validation
As a quality consultant and quality system subject matter expert in the Life Sciences Industry…
CertaraJune 29, 2018
Achieving Compliance with the FDA’s eCTD Mandate
The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance…
CertaraMay 4, 2018
Using M&S to Evaluate Oncology Drug Dosing
There are numerous challenges in developing oncology drugs: (1) they are often very toxic which…
CertaraApril 13, 2018
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…
CertaraMarch 16, 2018
The Many Challenges of Narrative Writing
Narratives are an essential part of any programs’ story, but often become cumbersome due to…
CertaraMarch 13, 2018
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…
CertaraMarch 2, 2018
