Preclinical Bioanalysis
Alderley Analytical are experts in preclinical bioanalysis. If your compound is moving towards preclinical development, you need robust bioanalytical assays to provide you with reliable data to support your molecule as it moves through early discovery experiments into regulatory safety studies. Good news, you’re in the right place.
We offer a non-regulatory and fully compliant regulatory service to meet all of your needs to support the bioanalysis of your molecule through the preclinical phase of your drug development project prior to getting into the clinic.
Preclinical sample volumes can be challenging and usually microsampling techniques are used. We are very experienced in handling microsamples, and we have the most sensitive instrumentation to detect your molecule in samples with limited volume.
Alderley Analytical can develop a suitable assay for your needs and fully validate the assay according the the FDA/EMA guidelines. We can also perform stability testing of your molecule in the biological samples to help you understand the most appropriate storage conditions.
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Non-Regulatory Bioanalysis
We can provide high throughput, rapid turnaround results for your discovery workflows or fit-for-purpose analysis to support early non-regulatory toxicology studies.
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GLP Regulatory Bioanalysis
We offer a fully compliant bioanalytical service to fully support the regulatory bioanalytical needs for preclinical safety studies as part of your drug development program.
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Toxicokinetics
We have both the expertise and the software capability to calculate and interpret the toxicokinetic results from your toxicology studies.
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Formulation Analysis
Our formulation department can analyse your dose formulations from non-regulatory and regulatory studies for achieved concentrations, critical for interpretation of toxicology studies.
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