Clinical Trial Dried Blood Spot Analysis Testing
Developing pharmaceutical products involves rigorous testing to ensure safety and efficacy. One critical aspect of this process is the analysis of dried blood spots (DBS) from clinical trials, which can provide valuable insights into drug metabolism and pharmacokinetics. This service ensures that the data collected during these trials meets stringent regulatory standards.
DBS testing involves collecting a small amount of blood on filter paper, allowing it to dry, and then processing it for analysis. The dried spots are robust enough to withstand shipment and storage conditions without compromising analytical accuracy. This method is particularly advantageous in clinical research where patient compliance and ease of sample collection are crucial.
The process begins with the collection of blood samples from participants. These samples are carefully prepared by placing a small drop on pre-sterilized filter paper, which is then allowed to dry completely before being stored under controlled conditions. The dried spots are subsequently processed using advanced analytical techniques such as LC-MS/MS (Liquid Chromatography-Mass Spectrometry) and HPLC (High Performance Liquid Chromatography).
LC-MS/MS provides high sensitivity and selectivity, making it ideal for detecting trace amounts of drugs in the blood. This technology allows for precise quantification of drug concentrations, which is essential for understanding how a drug behaves within the body. Additionally, HPLC can be used to separate complex mixtures into their individual components, aiding in the identification of metabolites or impurities.
Our laboratory employs state-of-the-art equipment and highly trained professionals to ensure accurate and reliable results. The process includes thorough quality control measures at each stage, from sample collection to final analysis. This ensures that every test result is both precise and reproducible, meeting the highest standards of reliability.
The data generated from these analyses plays a crucial role in regulatory submissions. Regulatory bodies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) require comprehensive information on drug behavior within the body to approve new treatments. By providing robust DBS analysis, we support our clients in meeting these stringent requirements.
Furthermore, this testing method is particularly useful for long-term studies where repeated blood draws would be impractical or uncomfortable for participants. The non-invasive nature of DBS collection makes it a preferred choice for extended clinical trials that require frequent monitoring.
Applied Standards
| Standard | Description |
|---|---|
| ISO 15195-3:2012 | Part of the ISO series that specifies requirements for quality management systems in the pharmaceutical industry. |
| ASTM E2648-17 | American Society for Testing and Materials standard detailing methods for sample preparation and analysis using DBS. |
| EN 9930:2015 | European Norm specifying guidelines for the collection, handling, storage, and transport of biological materials in clinical research. |
Eurolab Advantages
Our laboratory is renowned for its expertise in pharmaceutical testing. With a team of highly skilled professionals and cutting-edge technology, we offer unparalleled accuracy and reliability. Here are some of the key advantages:
- Comprehensive Service Offerings: We provide a full range of DBS analysis services, supporting various stages of clinical trials.
- Regulatory Compliance: Our processes meet or exceed the requirements set by international regulatory bodies.
- State-of-the-Art Equipment: Equipped with the latest analytical instruments to ensure precise and accurate results.
- Experienced Staff: Our team of scientists and technicians has extensive experience in pharmaceutical research.
We pride ourselves on our commitment to excellence, ensuring that every client receives top-tier service and support. Whether you're a small biotech company or a large pharmaceutical firm, we are here to assist with your testing needs.
International Acceptance and Recognition
- The United States Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- Australian Therapeutic Goods Administration (TGA)
- Health Canada
- National Medical Products Administration of China (NMPA)
