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.
My support process involves:
- Understanding the physicochemical properties of a drug molecule to develop analytical methods that are robust and specific
- The use of various extraction techniques e.g protein precipitation, solid phase extraction, ion exchange and liquid-liquid extraction techniques
- Column chromatography and tandem mass spectrometry expertise (LC MS/MS)
- Develop and optimise analytical methods that are required to support low picogram assays
- Mitigate ion suppression and matrix effects through evaluation of the role of phospholipids in sample extracts
- Review, troubleshoot and improve analytical methodology to provide reliable and accurate data
- Working in accordance with in-house SOPS and regulatory requirements, allowing for ease of Validation
How I can support you
Design
I can initiate the Method Development from start to completion. This would typically require me to become part of your in-house team to ensure we are fully aligned on the project.
Review
If you have the resources in-house to undertake the initial design, I can provide that 2nd pair of eyes to ensure that all the acceptance criteria are met for the purposes of the intended assay and are fully compliant with guidelines and recommendations set out by the regulatory authorities and ICH M10 to ensure the successful completion of the Method Development process
Case study - Method Development
At GlaxoSmithKline, I designed and developed a method for the determination of drug concentration levels of 15 EETS and 14,15 DHETS (small molecule biomarkers) in human plasma
What I did
The method I developed ensured chromatographic separation of the analytes of interest to accurately assess the effects of a SEH inhibitor on the regulation of the biomarker drug concentration
How I did it
Thanks to my design, a method was developed and used successfully to support a first-time, in Human study with increasing dosages of a soluble epoxide hydrolase inhibitor.
Result
The successful results of this method can be seen in this National Library of Medicine publication.
Publication
Other Services
Method Validation
When undertaking studies that will be subjected to regulatory submissions, key steps and processes must 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.
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.
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