Clinical Bioanalysis
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Study Support for Small- and Large-Molecule Candidates
Our Clinical Bioanalytical Services team provides study support for small- and large-molecule generic/biosimilar and innovator drugs, including sample management for global clinical trials.
Clinical study support services:
- Small- and large-molecule LC-MS/MS and Ligand Binding platforms
- Generic and innovator study support
- Clinical PK sample analysis
- Radiolabeled hAME sample analysis and study support
- Clinical metabolite ID and (radio) profiling: 3H and 14C
- MIST cross-species metabolite comparison
- 14C-labeled and 19F-NMR mass balance
- Soluble, genetic, cellular and tissue biomarker analysis
- Whole blood count
- Urinalysis
- Chemistry
- Basic immunology
- Coagulation
Project Management
- Data storage
- Sample management, storage and transport
- Material management
Clinical Bioanalysis FAQs
What is clinical bioanalysis?
In clinical bioanalysis, drugs, metabolites, and biomarkers in biological samples collected from clinical trials are quantitatively measured. This is essential for evaluating drug candidates’ pharmacokinetics, pharmacodynamics and therapeutic effectiveness in humans.
Why is clinical bioanalysis important?
Clinical bioanalysis is crucial for understanding how a drug functions in the human body. This data is essential for establishing correct dosages, comprehending drug interactions, monitoring therapeutic levels and guaranteeing patient safety.
What types of samples are analyzed in clinical bioanalysis?
Typical samples for clinical bioanalysis include blood, plasma, serum, urine, saliva, and tissue biopsies. These samples are examined to determine the levels of drugs, metabolites, and biomarkers.
What analytical techniques are used in clinical bioanalysis?
Frequently employed techniques in clinical bioanalysis include liquid chromatography-mass spectrometry (LC-MS), gas chromatography-mass spectrometry (GC-MS) and a variety of immunoassay methods, such as enzyme-linked immunosorbent assays (ELISA). These methods offer high sensitivity and specificity in detecting analytes.
How are bioanalytical methods validated for clinical studies?
Bioanalytical methods for clinical studies undergo validation in accordance with regulatory guidelines to guarantee accuracy, precision, sensitivity, specificity, reproducibility and robustness. This validation ensures the production of reliable and consistent results from the methods.
What regulatory guidelines govern clinical bioanalysis?
Clinical bioanalysis must adhere to regulatory guidelines set forth by international regulatory bodies. These guidelines establish the criteria for method validation, sample analysis and data reporting.
Can customized bioanalytical services be provided for specific clinical trials?
Yes, specialized bioanalytical services can be customized to accommodate the specific requirements of various clinical trials. This encompasses developing and validating distinctive analytical methods to address particular research inquiries.
How long does it typically take to complete a clinical bioanalysis study?
The length of a clinical bioanalysis study is determined by the project’s complexity, the number of samples and the necessary analytical methods. Timelines are typically established and approved during the project planning phase.
What types of clinical bioanalysis services does WuXi AppTec provide?
We offer clinical bioanalysis for small and large molecules using LC-MS/MS and Ligand Binding platforms, supporting generic/biosimilar and innovator drugs.
How does WuXi AppTec support clinical trials?
Our services include sample management, clinical pharmacokinetics (PK) sample analysis, and radiolabeled human Absorption, Metabolism, and Excretion (hAME) study support.
What additional testing does WuXi AppTec offer in clinical bioanalysis?
We provide clinical metabolite identification and profiling, cross-species metabolite comparison and comprehensive biomarker analysis.
How does WuXi AppTec ensure sample integrity during clinical trials?
We manage all aspects of sample management, including storage, transport, and material management, to ensure sample integrity throughout the study.