Bioanalytical services - Method development and validation

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Bioanalysis is an indispensable part of drug discovery and development. It relates to the analysis of analytes (drugs, metabolites, biomarkers) in biological samples. Bioanalysis involves 3 steps:
• Sample collection
Either from clinical or preclinical studies.
• Sample preparation
A robust sample preparation method is essential in order to obtain dependable results. Sample clean-up is typically time consuming and labor intensive.
• Sample analysis and detection
Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is the preferred method for sample analysis in the context of clinical studies and drug development. LC-MS/MS has proven to be highly selective and highly sensitive.

Bioanalytical method development

A fully validated bioanalytical method is essential to generate dependable results. At BioNotus, methods and techniques for bioanalytical development and validation are subject to continuous innovations. Each bioanalytical method in the BioNotus assay portfolio is the result of custom method development according to the highest standards. Specific method validation criteria are in line with EMA / FDA regulations.
To support routine sample analysis, a tailored bioanalytical method is developed, validated as follows:
• Reference standard preparation
• Bioanalytical method development and establishment of assay procedure
• Application of validated bioanalytical method to routine drug analysis and acceptance criteria for the analytical run and/or batch
• Iterations of the above steps to improve assay performance

Bioanalytical method validation

During the course of a typical drug development program, a bioanalytical method will undergo many modifications. Different levels of validation are required to demonstrate continuity of the validity of an assay’s performance. Three different levels of bioanalytical method validation are defined:
• Full validation
When developing a new bioanalytical method for a new drug entity, full validation is required.
• Partial validation
A partial validation is a modification of an existing validated method that doesn’t require full revalidation. Partial validation of a bioanalytical method can vary from one assay accuracy and precision determination to a nearly full validation.
• Cross validation
A cross validation is necessary when 2 or more bioanalytical methods are combined to generate data within the same study. Cross validation is actually a comparison of two separate bioanalytical methods.

BioNotus is a contract research organization (CRO) specialised in the bioanalysis of drugs (medicines) in a diversity of complex (biological) matrices:

+ Blood, serum and plasma
+ Tissue and tissue homogenates
+ Cell lysates
+ Cell culture media
+ Dried blood spots

+ Urine
+ Saliva
+ Breast milk
+ Waste water from pharmaceutical production

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