Tier 5 - Full 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.

• Providing a tailored approach for non-clinical GLP and clinical GCP projects that need rigorous validation and compliance with GLP (Good Laboratory Practice) and GCP (Good Clinical Practice) standards

• 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 5 - Full Validation bioanalytical services

‍The Tier 5 - Full Validation is designed to support of non-clinical GLP and clinical GCP projects, with validations being conducted according to industry guidelines. Studies are managed as separate method development, method validation and sample analysis studies, with Quality Audit of the method validation and sample analysis studies. The method development study will include pre-validation assessments to ensure the method is suitable to progress to validation, and stable label internal standards used to ensure method robustness. Long term stability in matrix will be assessed to cover the sample storage period. Incurred sample reanalysis (ISR) can be included where required e.g. for pivotal clinical trials.

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.