Dose Formulation Analysis Done Across the Hall
(not across town or across the country)
The FDA requires that for every GLP in-life study, the dose formulations are tested to ensure they are the appropriate concentration, as laid out in the protocol.

Dose Formulation Analysis is a staple in the industry - a must-have; no longer just a nice-to-have.

At the FDA, emphasis is placed on robust analytical methods to give confidence to Sponsors and regulators that the dose formulations prepared are exactly what is required for the in-life studies. They're getting a lot more specific about what they want to see in each run, how many controls they want to see, and what sort of acceptance criteria is allowed. The foundation of all Dose Formulation Analysis is the Whitmire white paper entitled ‘NonClinical Dose Formulation Analysis Method Validation and Sample Analysis’  The AAPS Journal, Vol 12, No. 4. Since its publication in 2010, the FDA has also published a paper with the specific requirements for bioanalytical analysis, and we use those guidelines as a stepping stone for even better method development. Even when the instrumentation is a little bit different – in the case of Dose Formulation Analysis, for instance – the theory is the same.

As a research scientist and the Analytical Study Director here at Attentive Science, I am responsible for Method Validations and Dose Formulation Analysis to support our  clients’ studies. One of the reasons clients choose Attentive to do these in-house studies is the short turnaround time we offer. In addition, Attentive Science has the capability of providing Method Validation and Dose Formulation Analysis as a Principal Investigator. Short backlogs and automated reporting helps ensure that you get your results quickly and accurately.

When formulations are subcontracted to other companies, there is often a wait time experienced before samples can be run as samples must be shipped to other laboratories. By allowing Attentive to conduct the entire process in-house, it greatly reduces the wait time, because I can have the samples on the instrument the day that they are prepared and results to the study directors within 24 hours. All because we're just walking samples from one lab to the other.

Attentive Science began offering our Dose Formulation Services over the last year, and we have already seen a marked appreciation by our customers for the way that we have set these services up. Prior to implementing these services – as part of an introductory call with a client – the question would always come up: “Do you have DFA in-house?” This was because clients understand that it's important to know what the dose is before it's administered. By simply continuing their project across the hall – rather than across town or across the country – we have been able to save our customers time and money.

If you feel like your project could benefit from this level of speed and convenience, let us know and an Attentive Science specialist will reach out to set up a meeting!

Attentive will be offering insightful presentations at SOT 2023.
You won't want to miss these!