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I hope you find some useful nuggets in my posts. "Start here" is a table of contents and a great place to start. Otherwise you can click, tap, scroll and search to your heart's content!

Please note that I will be adding new content as mentioned in "Coming Soon" posts for each section.

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Quality by Design

QbD focuses the the study on maximizing important aspects (key efficacy and safety) and minimizing the less important areas, especially if they are burdensome or risky!

Critical-to-Quality factors and Quality Tolerance Limits: what are they and how do we choose?

Critical-to-Quality factors and Quality Tolerance Limits: what are they and how do we choose?

Critical-to-Quality factors and Quality Tolerance Limits: what are they and how do we choose?

To start, here's a definition of Critical-to-Quality (CtQ) factors from ICH E8 (R1) [1] : “ A basic set of factors relevant to ensuring...

Jun 244 min read

A Quality by Design Process for Studies

A Quality by Design Process for Studies

A Quality by Design Process for Studies

Quality by Design (QbD) is a broad approach and way of thinking. During the process of evaluating Quality by Design, Critical-to-Quality...

Jun 244 min read

Quality by Design (QbD) Intro: Let's get practical and tactical.

Quality by Design (QbD) Intro: Let's get practical and tactical.

Quality by Design (QbD) Intro: Let's get practical and tactical.

If you want to read up and learn more about QbD, here are some great resources: Introductory article from DIA ICH E8 R1 CTTI website with...

Jun 247 min read

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