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Nuclear Medicine in the Treatment of Cancer

Index Acknowledgements Introduction Theory behind radiation & radioactivity Radiopharmaceuticals – what, why & how The future References Bibliography Acknowledgements This article would not have seen its completion without Kvalito Consulting Group, my team,...

The Grand Promise of Small Molecules

A continued trend in novelty saw the FDA (Food and Drug Administration) approving many structurally innovative drugs in 2020.    Powerful innovation of new drugs, biological products, and medical care usher in the promise of new and better treatment options for...

The Applicability of FDA’s Computer Software Assurance Guidance to Data Integrity

As technology progresses, new approaches to software inspection continue to be found. In the webinar ‘Understand the Applicability of FDA’s Software Assurance Guidance to Data Integrity’ (linked below), a new approach to validation is introduced. Computer Software...

Taking Shape: Artificial Intelligence Regulation and its Impact on CSV/CSA (III)

Part III: Overview   Overview of CSV for AI-based systems Artificial Intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. AI-based systems are software systems with functionalities enabled by at...