Through our bioanalytical services group, Diteba, we offer method development, validation and specimen analysis using state-of-the-art laboratory equipment and techniques. These include Ultra Performance Liquid Chromatography Mass Spectrometry (UPLC/MS/MS) as well as liquid and gas chromatography techniques.
Reaching your milestones efficiently requires well-informed decision-making built from confidence in the data. Our dedicated method development teams have extensive experience developing and validating robust bioanalytical methods in blood and other biological matrices to support pre-clinical and Phase I through Phase IV clinical trials for both dietary supplements and drugs.
Our scientists have extensive experience developing and validating bioanalytical methods in various biological sample types to support your pre-clinical studies through Phase III clinical trials. Our bioanalytical services are performed in compliance with GLP and comply with Health Canada and U.S. FDA guidelines. Working in close collaboration with our pre-clinical and clinical project managers, we work as a team to ensure the project goals are met.
Our bioanalytical testing services include:
- Assay method development, validation and transfers
- Expertise in many proven validated methods to quantitatively measure all types of compounds, small or large molecule, using:
- HPLC - GFC
- UPLC—UV, Fl, ECD
- Capillary Electrophoresis (CE)
- ELISA (Immunochemistry)
- Gel Image Analysis System
- Feasibility assessments
- Metabolite identification using LC/MS/MS
Pre-clinical trial support
- Bioanalysis of drug and metabolites in biological fluids
- Sample analysis technologies in multiple biological species and matrices for human and animal studies
- Toxicokinetic (TK)
Clinical trial support
- Pharmacokinetic (PK)
- Bioavailability Studies
- Bioequivalence Studies
- Drug Interaction Studies
Large molecule analysis
- Phospholipids, fatty acids
Routine specialized bioanalytical methods for generic and branded drugs, dietary supplements and in support of in vivo toxicology studies
- Plasma eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)
- Red blood cell EPA and DHA
- Red blood cell fatty acid profile
- Plasma fatty acid profile
- Plasma phospholipid fatty profile
- Lovastatin hydroxy acid (LHA)
Looking for more information on bioanalytical testing? Check out Diteb's official website, or contact a member of our team to request a specialized quote.