Method Validation
When undertaking studies that will be subjected to regulatory submissions, it is imperative that key steps and processes follow specific guidelines and industry standards, as set out by the EMEA, ICH M10, prior to submission. Ensuring that the Method Validation is compliant and successfully audited will contribute to the successful delivery of the project objectives.
How I can support you
Evaluation
I will review the robustness of your analytical method to ensure accuracy, precision, stability, linearity, dilution, robustness and specificity standards are achieved.
Review and Training
If you don't have the resources in-house with this skillset, I can also train your team while undertaking the evaluation, and be available to provide continued support to ensure optimum performance of the analytical method during sample analysis.
Case study - Method Validation
For this study I validated the method design to ensure that Zanamivir was adequately retained.
What I did
Highly polar compounds, e.g Zanamivir, are not easily retained using standard reverse-phase chromatography. I used Hydrophilic Interaction Liquid Chromatography (HILIC) to allow for the retention of Zanamivir.
How I did it
As a result of this change, the method was adopted to support studies to determine the concentration of Zanamivir in rat and monkey plasma.
Result
The successful results of this method can be seen in this Journal of Chromatography publication.
Publication
Other Services
Method Development
As a bioanalytical expert, I have developed numerous assays across a range of complexities for the quantification of small drug molecules and biomarkers in biological matrices. I am able to provide the in-house technical expertise necessary to develop low picogram assays to support PK and PD studies for key decision-making and, if required, I can also train your teams on my methodology.
Protocol Review, Data & Report Checking
The goal in reviewing the bioanalytical aspect of a study is to ensure the collection, storage, sample volumes, transport, sample treatment and handling are consistent with the validated method to ensure data integrity. Inconsistency and errors in data and report checking can impact the final results and study interpretation and therefore can cause inaccurate decision-making.
Contact
© Copyright. All rights reserved.
We need your consent to load the translations
We use a third-party service to translate the website content that may collect data about your activity. Please review the details in the privacy policy and accept the service to view the translations.