Analytical Method Authoring: Ensure that your Method is User Friendly for Quality Control- Part 2

In part 1 of this blog post, I wrote about ways to make sure that the HPLC analytical method that you are developing is user friendly for the QC laboratory that will be performing the drug substance or drug product release.  I am focusing on methods required for release of Phase 1 or Phase 2 clinical trial materials.  Many of these items are also helpful for non-QC labs that receive the...

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Analytical Method Authoring: Ensure that your Method is User Friendly for Quality Control- Part 1

As an HPLC analytical method development veteran, I know that we all have a way that we like to write methods that make sense to ourselves.  However, it’s very important to keep the end user of your “product”, the method, in mind.    Since methods have quite a few sections, I will discuss this over several blog posts, targeting methods validated for Phase 1 and Phase 2. It’s important...

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