Tier 3 – Discovery+ Customized

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.

• Designed for clients who require a truly customized method for their compound(s) and are less averse to resource commitment and/or longer allocations of time for method development
• 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 3 – Discovery+ Customized bioanalytical services

‍Discovery+ Customized is as a fit-for-purpose service, designated for clients who require a truly customized method for their compound(s) and open to committing resources and/or longer allocations of time for method development. This offering understandably consists of tighter acceptance criteria to ensure that the final method is both selective and sensitive enough to warrant the nomenclature of ”Customized”. Prior to any sample analysis undertaking, precision and accuracy assessments are conducted, as a further commitment to robustness and ensuring data validity. Given the association with method development for this tier, your study can be managed as a combined method development and sample analysis project or can be separated into distinct studies to ensure that you have full transparency and oversight over your assets and data. As with all tiers, reporting options are available, from simple data tables to formal written data reports. Alongside our standard templates, we have the capacity to tailor these documents to your requirements.

What does Tier 3 – Discovery+ Customized 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.