In Vivo Pharmacokinetics (PK) & Bioanalysis

Our DMPK experts help steer your project to success with a clear insight into the pharmacokinetics of your therapeutic. The team develop impactful in vivo PK studies before generating and interpreting data that helps you make informed decisions about the next stage of your project.

• We provide expert DMPK guidance throughout the drug discovery process, and work with our medicinal chemistry and biology experts to successfully steer your project towards the clinic
• The team has combined decades of experience in developing and customizing chromatographic methods for the quantitative determination of small molecules. We provide bioanalytical support through the entire paradigm of discovery PK to clinical proof of concept studies, enabling you to take your molecule from concept to the clinic
• We provide rapid turnaround of discovery pharmacokinetic and distribution studies, initially through non-regulatory and regulatory (GLP) PK support.  We continue to support through to phase 1 and phase II (GCP) clinical trials, providing our clients with a custom, advisory approach to solving their bioanalytical challenges

Get greater flexibility and better results with our tiered bioanalysis services

‍Collaborative discussion forms the foundation of study plans, through which our highly experienced scientists can provide consultative oversight. We consider factors such as compound complexity, submission requirements, timelines, and budgets, advising on key matters such as bioanalytical methodology or in-life study designs. Understanding these needs, we have developed a tiered system to help manage the costs associated with our bioanalysis services while ensuring you receive data swiftly to support the decision-making process. 

• PK screening: a cost-effective option for optimization and compatibility testing of your compound, using minimal material and reducing animal usage
• Tier 1 – Discovery: Entry-level rapid and robust data generation utilizing proven methodologies, ideal following on from screens or for simple, generic compounds
• Tier 2 - Discovery+: enhanced bioanalysis with method development for your discovery projects, prioritizing specificity, speed and high-quality results
• Tier 3 - Discovery+ Customized: is a customized bioanalytical service for clients needing tailored methods and willing to invest time and resources into method development and robustness testing
• Tier 4 - Scientific Validation: supports in vitro projects and early-stage non-regulated/non-clinical/clinical analyses, offering method validation in addition to standard services, with separate studies for development, validation, and analysis, and optional QA audits
• Tier 5 - Full Validation: supports non-clinical GLP and clinical GCP projects, conducting validations per industry guidelines with separate method development, validation, and analysis studies, including optional QA audits, long-term stability assessments, and incurred sample reanalysis (ISR) for pivotal trials

‍Discovery and regulatory bioanalytical expertise

‍Our discovery and regulatory compliant bioanalytical services provide quantification of test drugs, metabolites or biomarkers, using ABSciex and Waters LC-MS/MS systems, within in vitro or in vivo samples. Additionally, we support alternative biomarker assays and in vivo biotransformation. We work to the highest industry standards offering a range of method acceptance criteria, from discovery best practices to regulated GLP and GCP projects. This ensures our data meets your requirements while maintaining the highest quality. 

After developing accurate and selective methods, our regulatory studies are conducted in GLP accredited laboratories, enabling us to offer fully regulated bioanalytical validation and sample analysis This supports your non-clinical and clinical studies throughout the submission process.Consistent points of contact, direct with scientists, guarantee transparency and traceability throughout studies and projects, from screening, to method development, through to regulated sample analysis and PK data interpretation. This approach preserves data integrity and ensures projects are completed efficiently and in line with your desired timeline.

Your in vivo PK & bioanalysis services partner

‍A single point of contact at Concept Life Sciences ensures our clients receive excellent support through the various studies within a project (method development to sample analysis) and all elements of the project are performed to the highest quality to ensure data integrity. Fast quality-assured interim data can be provided throughout the life cycle of the clinical trial to aid rapid decision-making.

Method development

‍Additional method development allocation is available at any stage of the bioanalytical process. We offer consultation and advice, fixed resource allocations for experiments, or open-ended method development agreements, tailored to your study's complexity, budget, and timelines. Start a discussion with our team today to learn how our tiered structure can help you minimize costs and maximize outputs!

Find out how we can help you throughout the lifecycle of your drug discovery program and have a confidential discussion with our experts.