Pharmacokinetics & Bioavailability Testing
In the pharmaceutical sector, understanding how a drug behaves in the body is critical to its development and approval. Pharmacokinetics (PK) focuses on the absorption, distribution, metabolism, and excretion of drugs within the human body, while bioavailability refers to the extent and rate at which the active ingredient becomes available at the site of action after administration.
At Eurolab, we offer comprehensive pharmacokinetic and bioavailability testing services that ensure compliance with international standards such as ICH Q2 (R1), US FDA guidelines, and EU directives. Our team of experts uses advanced analytical techniques to provide accurate data on drug absorption, distribution, metabolism, and excretion.
Our PK studies typically involve oral administration in humans or animals, where we measure the concentration of the drug over time. This helps us determine key parameters like area under the curve (AUC), peak plasma concentration (Cmax), time to reach maximum concentration (Tmax), half-life (t1/2), and clearance (CL). These metrics are essential for understanding how quickly a drug is eliminated from the body, its distribution in different compartments of the body, and its metabolism.
For bioavailability testing, we can assess both absolute bioavailability (compared to intravenous administration) or relative bioavailability (compared to a reference product). This helps us evaluate the extent and rate at which the active ingredient is absorbed into systemic circulation. We use various methods such as single-dose studies, multiple-dose studies, and pharmacokinetic/pharmacodynamic modeling.
Our laboratory adheres strictly to Good Laboratory Practices (GLP) and follows strict quality control measures to ensure accurate results. Our state-of-the-art facilities are equipped with advanced chromatographic techniques like HPLC, UHPLC, and LC-MS/MS for precise quantification of drug concentrations.
We also provide detailed reports that include not only the quantitative data but also interpretive comments based on our extensive experience in pharmaceutical research. These insights help clients make informed decisions about formulation optimization or process improvements.
Industry Applications
- Evaluation of new drug candidates for first-in-human studies.
- Determining bioequivalence between generic drugs and their reference products.
- Optimizing drug formulations to enhance absorption or reduce side effects.
- Assessing the impact of excipients on drug performance.
- Supporting regulatory submissions by providing robust PK data.
Our services are widely used across various pharmaceutical companies, both large and small, to ensure product safety and efficacy. By leveraging our expertise in pharmacokinetics and bioavailability testing, these organizations can better understand their drug candidates' behavior in the body, leading to more effective treatments for patients worldwide.
Eurolab Advantages
- Compliance with International Standards: Our services comply with ICH Q2 (R1), US FDA guidelines, and EU directives.
- Advanced Analytical Techniques: We employ cutting-edge chromatographic methods such as HPLC, UHPLC, and LC-MS/MS for precise drug quantification.
- GLP Adherence: Our laboratory follows Good Laboratory Practices to ensure accurate and reliable results.
- Experienced Team: Our experts have extensive experience in pharmaceutical research, providing clients with valuable interpretive comments based on their findings.
- State-of-the-Art Facilities: Equipped with the latest technology for comprehensive drug evaluation.
- Rapid Turnaround Time: We prioritize client projects and offer quick turnaround times without compromising on quality.
At Eurolab, we pride ourselves on delivering high-quality, reliable data that meets regulatory requirements and supports innovative drug development. Our commitment to excellence ensures that our clients can trust us to provide accurate and actionable insights into their drug candidates' behavior in the body.
Why Choose This Test
- Predictive Power: PK studies help predict a drug's performance before it reaches clinical trials, saving time and resources.
- Informed Decision-Making: Bioavailability testing provides crucial information for optimizing formulations or comparing different processes.
- Regulatory Compliance: Our services ensure that clients meet all necessary regulatory requirements, facilitating smoother drug approvals.
- Expertise and Experience: Our team has extensive experience in pharmaceutical research, providing valuable insights based on their findings.
- State-of-the-Art Facilities: Utilize the latest technology for comprehensive drug evaluation, ensuring accurate results.
- Rapid Turnaround Time: We prioritize client projects and offer quick turnaround times without compromising on quality.
By choosing Eurolab for your pharmacokinetic and bioavailability testing needs, you can be confident in the accuracy and reliability of your data. Our services not only comply with international standards but also provide valuable insights that can lead to improved drug formulations and enhanced patient outcomes.
