Trends for Market Access, HEOR, and Real World Evidence Blog Post
This blog reviews trends for using health economics and outcomes research and real-world evidence to evaluate the value of medicines and health technologies.
Introducing P21 Community 3.0 Blog Post
May 7, 2019 We are thrilled to announce that P21 Community 3.0 is available for immediate download. This is our most ambitious release to date. We added support for new standards...
New Pinnacle 21 Enterprise 4.0 Eases Concern about PMDA Submissions Blog Post
April 2, 2019 Released March 31, the new P21 Enterprise 4.0 provides more options for submitting study data to the Japanese health authority PMDA, plus better ways to manage validation...
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…
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…
FDA’s New ANDA Submissions Guidance: Key Points Blog Post
The U.S. Food and Drug Administration (FDA) published notice of a new ANDA submissions guidance on September 24. The final guidance for industry titled, “ANDA Submissions – Content and Format” is…
