Bioanalytical Package

In the drug development phase, whether candidate compounds are small molecules, large molecules or generic drugs, data from preclinical to clinical trials are required. Dependable bioanalytical support is critical to effectively screen candidate compounds from the laboratory through clinical trials. And in an ever-changing regulatory environment, multi-disciplinary scientific and regulatory expertise must transfer into developing accurate methods that produce the data to make decisions faster.

Compared to independent assays, comprehensive bioanalytical solutions save time for researchers and meet multiple regulatory environments around the world. Meanwhile, the data consistency of candidate compounds can be guaranteed.

Creative Bioarray's bioanalytical services follow procedures in which both QC/QA and GLP-compliance are implemented. Our department is committed to working with clients to combine rich experience and expertise with a unique and flexible approach to each project individually, and to provide solutions tailored to the clinical phase and specific needs.

Services include:

• LC-MS/MS method development & validation
• GLP method development & validation
• Specimen analysis for preclinical and clinical trials
• Drug profiles and administration route
• Immunochemistry & ELISA
• Bioanalysis in multiple matrices
• Metabolite screening and identification
• PK/TK assay
• Bioavailability & bioequivalence studies
• Biomarkers analysis
• Non GLP / GLP drug discovery

Creative Bioarray provides bioanalysis and PK/TK data to help our customers make ongoing decisions. This is particularly useful in proof-of-concept and clinical development studies. Our team will ensure to provide high quality of services for our clients. Please feel free to contact us to find out more about our capabilities and services.