The term "bioanalysis" refers to the quantitative measurement of analytes (i.e., drugs and their metabolites) and biomarkers in biological matrices such as serum, urine, and different body tissues. In other words, bioanalysis refers to the analytical procedures performed in a laboratory environment on biological samples.
Bioanalysis of the drug begins at the preclinical stage, when the drug is being tested for its efficacy, toxicity, and pharmacokinetics (how the body affects the drug). During this stage, tests should be performed under Good Laboratory Practice (GLP) requirements in order to protect the integrity of the data. Bioanalytical testing for clinical trials is performed under cGMP requirements.
The development of bioanalytical methods raises some unique challenges. Two of these challenges are the low limit of detection (the lowest concentration for which the analyte can be distinguished) and the low limit of quantitation (the lowest concentration for which the analyte concentration can be quantified). This challenge is even greater in small animals, where the initial dose is significantly lower.
Tip from our scientists
Bioanalytical studies should be performed in compliance with GMP or GLP according to the developmental stage. In order to save time and money, it is recommended that bioanalytical method development, validation, and testing will be performed by the same laboratory. Choosing a supplier that holds both GLP and GMP credentials will help you to avoid a technology transfer.
Services for you
Development and validation of bioanalytical methods for quantitation of active drugs, natural compounds, and metabolites.
Testing of tissues and body fluids such as plasma, serum, urine, vitreous fluid, CSF, and cerebral fluid.
GLP testing and documentation.
Preparation of test articles for pre-clinical efficacy/toxicity studies.