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…
Using IVIVC to Optimize Your Drug Formulation After a Failed BA/BE Study Blog Post
This webinar introduced how IVIVC can be used to get your drug program back on track! Learn how to analyze a failed BE study and use IVIVC to explore better dissolution tests, predict your target dissolution to meet the reference, and optimize your drug’s formulation.
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…
Apixaban for treatment of venous thromboembolism (VTEtx): Use of MBMA to support Phase 3 dose selection and beyond Blog Post
Apixaban is an orally available, direct, selective inhibitor of the coagulation factor Xa that reversibly binds to the active site of FXa, and exerts anticoagulant and antithrombotic effects by diminishing…
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...
Achieving Compliance with the FDA’s eCTD Mandate Blog Post
The US Food and Drug Administration (FDA) has set May 5, 2018 as the compliance date for submitting many types of files—Drug Master File (DMFs) and commercial investigational new drugs…
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…
Using a Pharmacology to Payer Framework to Support Product Development Blog Post
Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains with a variety of domain-specific approaches and applications. The pharmacology to payer (P2P) concept is…
The Many Challenges of Narrative Writing Blog Post
Narratives are an essential part of any programs’ story, but often become cumbersome due to the many challenges of narrative writing. A large narrative project is typically divided into several…
