At Synergy Bioscience, our pharmacokinetics (PK) services are a cornerstone of the drug development process, providing crucial insights into the safety and efficacy of therapeutics. Our comprehensive PK profiling supports your project from the earliest stages of discovery through to clinical evaluation and beyond.
In-depth PK Profile Assessment
Understanding the PK profile of a therapeutic agent is vital. It informs decisions on dosage, route, and timing, impacting the success of preclinical and clinical trials. Our PK evaluations are meticulously designed to guide these decisions, ensuring optimal outcomes in drug development programs.
PK Assay Development and Validation
Our team of seasoned scientists brings a wealth of knowledge to PK assay development and validation. We adhere to the best practices and regulatory guidelines to deliver assays that meet the highest standards:
• Industry-Leading Practices: We are experts in developing and validating PK assays that meet regulatory expectations, ensuring your journey through the drug development pipeline is smooth and unimpeded.
• Complexity Consideration: We understand the complexities that can affect assay reliability. Our methods are rigorously validated to account for these factors, ensuring the integrity of the data.
• Data Interpretation: Our expertise extends to the interpretation of PK data, providing a detailed understanding of a drug’s absorption, distribution, metabolism, and excretion (ADME) properties.
• Diverse Species Analysis: We support PK analysis across various species, from rodents to nonhuman primates, and humans, facilitating comparative studies and translational research.
• Matrix Versatility: Our capabilities include working with numerous biological matrices, such as serum, plasma, urine, saliva, cerebrospinal fluid (CSF), ocular fluids, milk, tissue, and whole blood lysates, enabling comprehensive analyses.
• Regulatory Compliance: We deliver high-quality PK assay methodologies and results in strict compliance with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations and adhere to international standards set by bodies like the FDA, EMEA, and ICH.
Support at Every Development Phase
Whether your project is in the nascent stages or advancing toward clinical trials, Synergy Bioscience is equipped to support all drug modalities. Our services include:
• PK Assay Development: Custom assay development tailored to your therapeutic’s unique properties.
• Method Validation: Robust validation processes that ensure your assays perform consistently and accurately.
• Sample Testing: High-throughput and sensitive testing services to handle studies of any scale.
• PK Analysis and Reporting: Detailed analyses and comprehensive reporting to inform decision-making and support regulatory submissions.
Our Pledge to Excellence
At Synergy Bioscience, our commitment is to your success. We combine state-of-the-art technology with scientific rigor to ensure that your drug development path is supported by reliable and actionable PK data. Our team stands ready to partner with you, offering not just services, but solutions that propel your therapeutics forward.
Embrace the Synergy Bioscience advantage—where science meets strategy, and data paves the way for discovery. Let us be the catalyst in your journey to bring effective and safe drugs to the market.
