Tier 4 - Scientific Validation

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.

• Ideal for non-regulated, non-clinical, and clinical sample analyses during early development phases 
• Method development, method validation, and sample analysis are managed as separate studies, providing clear structure and focus for each phase, allowing you to have full oversight of every stage
• We provide you with a comprehensive and concise summary document containing analytical summary and comments, methodology, raw data, working solution scheme and representative chromatography

About our Tier 4 – Scientific Validation bioanalytical services

Our Tier 4 - Scientific Validation is suitable for support of in vitro projects, early development, non-regulated, non-clinical and clinical sample analyses where method validation assessments are required in addition to the offerings included in Tier 3. Studies are managed as separate method development, method validation and sample analysis studies, with the option of Quality Audit (QA) for method validations and sample analyses if selected. Method development studies include pre-validation assessments to ensure methods are suitable to progress to validation. The validation assessments will be based on industry guidelines, with flexibility as to which assessments are included. Typically, stability in matrix will be conducted up to a 1-month timepoint.

What does Tier 4 – Scientific Validation consist of:

• Compound optimization (MS and LC)
• Method development
• Precision and accuracy assessment
• Sample extraction
• Inclusion of internal standard (generic/analogue/stable label)
• Data processing ((concentration data, PK parameter interpretation available at request)
• Reporting

‍Find out more about our the other tiers

• PK screening: a cost-effective option for optimization and compatibility testing of your compound, using minimal material and reducing animal usage
• 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

Find out how we can help you rapidly evaluate the PK of your therapeutic and have a confidential discussion with our experts about your project needs.