Analytical Method Authoring: Ensure that your Method is User Friendly for Quality Control- Part 3

In parts 1 & 2 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...

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Developing a Stability-Indicating Method: Forced Degradation

At Velesco, we are occasionally asked to explain the process of developing a stability-indicating HPLC method.  One very important step in determining whether a method is stability-indicating is to perform Forced Degradation experiments.  Here, I will explain these experiments and how we approach the process. It’s important to challenge your analytical method for its ability to accurately...

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Topical Product Formulation – Getting the Terminology Right

One little mentioned aspect of topical product development that can be a challenge to client-CRO relations is that of terminology. There are a wide variety of terms used to describe product types; cream, ointment, lotion etc which many people use interchangeably yet, to the formulator each has a very specific meaning. As you can imagine this leads to some confusion and frustration so, in an...

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Velesco’s Non-Clinical Formulation Philosophy – Part 1

As I’ve gained more time in the CRO world versus big pharma, I have come to see that there are two fairly distinct schools of thought for determining pre-clinical formulations for very early stage compounds.  One uses the compound structure and an iterative process to determine an appropriate vehicle for early stage formulations.  The other uses a high throughput screening methodology...

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