Real World Evidence Marches Forward in Drug Development Blog Post
The end of 2018 ushered in a flurry of new regulatory guidance and sponsor enthusiasm on real-world evidence (RWE) and its adoption in the drug development process. While the collection…
Managing Immunogenicity Using Quantitative Systems Pharmacology Blog Post
The Challenge of Immunogenicity in Biologics Drug Development Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Biologically-based therapeutic drugs comprise monoclonal antibodies (MAbs), vaccines, recombinant hormones…
Define.xml Frequently Asked Questions Blog Post
Discover answers to common Define.xml FAQs, covering best practices, expert tips, and essential guidance for effective implementation.
7 Things to Know About the China Pharmaceutical Industry Blog Post
China is the second largest pharmaceutical market in the world. Demand is likely to increase as the government introduces reforms to improve the country’s health care system. These changes are…
How to Use a Reference-scaled Average Bioequivalence Approach for Narrow Therapeutic Index Drugs Blog Post
Watch this webinar to learn how RSABE for NTIDs can be performed in Phoenix WinNonlin using a reusable template.
Clinical Pharmacology Gap Analysis: Lessons Learned Blog Post
Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these needs, and providing a framework for how to satisfy them. This tool can create value for…
Overcoming Pitfalls and Challenges with Software Validation Blog Post
As a quality consultant and quality system subject matter expert in the Life Sciences Industry for over 25 years, I have worked for many pharmaceutical companies both large and small…
What’s New in Enterprise 3.4 Q&A Blog Post
Is there documented guidance on the creation of the sponsor SDTM metadata to be uploaded to Enterprise? In your demo, I noticed populated fields for the Core column differs from...
Using M&S to Evaluate Oncology Drug Dosing Blog Post
There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be…
