Metal testing in clinical and preclinical samples GLP
Biodistribution and Pharmacokinetic studies of drugs containing metal ions
Several drugs containing, metal ions are used in the treatment of severe medical conditions and illnesses. To determine drug dose, absorption, distribution, metabolism, and excretion of the metal ions in animal and clinical samples, new analytical technologies and tools have been developed for preclinical and clinical evaluation. The technologies allow for an evaluation of intended and unintended accumulation of metal ions in specific organs and body fluids.
To detect even minor differences in metal levels for specific samples Eurofins BPT offers to detect down to ppb level, due to the extensive possibilities for sample pre-treatment in microwaves and other sample preparation techniques as well as the specially designed high pressure room to safeguard samples from contaminating air particles.
Metal Competence Center services, Europe
Eurofins BPT offers the complete range of metal testing services for preclinical and clinical samples including:
- Method development and validation, according to EMA or ICH guideline.
- Testing of whole blood, serum, plasma, urine, faces and tissues such as kidneys, heart, liver, spleen, bone marrow, etc.
- Advice regarding analytical methods & approaches.
- Extremely low level detection of specific metals down to ppb level.
- Analytical Approaches
Eurofins BPT can help in the planning and execution of sample handling, selection of instrumentation and general instrument performance advice, optimized for specific testing needs. For example, detection levels are dependent on sample pre-treatment technique, sample digestion, choice of instrumentation, adapted to the available quantity of sample.
Eurofins BPT technologies include, standardized methods optimized for animal and human samples, special sample pre-treatment techniques, microwave digestion, ICP-AES and ICP-MS instrumentation.
All work is conducted according to GLP guidelines.
Quality approach
Eurofins BPT is proud to offer our clients a high level and very well documented quality service to international standards.
All equipment is installed and qualified according to US and European quality requirements.
Eurofins BPT operate according to GLP as described in OECD Principles on Good Laboratory Practice (ENV/MC/CHEM(98)17) and the subsequent consensus documents and departmental order no. 1245 of Dec 12th 2005 from the Danish Health and Medicines Agency on Good Laboratory Practice for medical products.
Why choose Eurofins BioPharma Product Testing
- Eurofins BPT has more than 35 years of experience developing and executing methods for metals analysis, using modern quantitative technology.
- The Competence Center has the expertise to troubleshoot complex sample matrices and method challenges.
- Eurofins BPT’s regulatory experience enables our analysts to ask the right questions and determine the most appropriate testing approach, delivering service that meets client needs.
- Comprehensive instrument capacity allows for rapid turnaround time.
