Dose Formulation Analysis

Ensuring accurate formulation and dosing concentrations for successful toxicology studies

Expert Formulation Analysis for Preclinical Studies

Formulation analysis is an essential support service for GLP toxicology studies and is often advisable on non-GLP studies when the accuracy of dosing solutions is critical. We offer a comprehensive formulation analysis service by our specialist team. We have extensive experience in developing and validating analytical methods, as well as analysing dose formulation samples.

Achieved concentrations of dose formulations are a regulatory requirement for GLP toxicology studies. Analysis of dose formulations, whether solutions or suspensions, is required to verify the concentration, accuracy and homogeneity of the formulation used for dosing (or in vitro testing) during preclinical programs. The stability of the dose formulations under the study conditions is also verified.

GLP Compliance

Our Manchester laboratory is fully GLP compliant, and our quality systems are regularly inspected by the UK MHRA (Medicines and Healthcare products Regulatory Agency) to demonstrate ongoing data integrity.

Custom Assay Development

A suitable analytical method is developed to quantify the test material in the formulation accurately. The method can involve techniques such as HPLC-UV or UPLC-MS/MS. It is particularly important to check for non-specific binding of the test compound on the dosing vessel and to investigate the most suitable materials needed to achieve successful validation.

Validation, Ensuring Reliability and Accuracy

The developed analytical method is validated to ensure its accuracy, precision, specificity, linearity and robustness. Validation ensures the method is reliable and provides consistent results.

Stability Testing, Guaranteeing Formulation Integrity

Stability is assessed under various conditions for different durations to facilitate an understanding of how formulations can be stored during use and how best to ship samples to the analytical facility. Typical testing will be at room temperature. 4^oC, -20^oC and -80^oC for up to 14 days.

Formulation Sample Analysis

The results of the quantification analysis are documented and reported in a comprehensive manner. This information is crucial for regulatory submissions, including Investigational New Drug (IND) applications.

Our Bioanalytical Platforms

Our technology platforms are robust, reliable and reputable in the clinical field and provide comprehensive and detailed data readouts for your application.