Enhance Your Drug Development with Our Pre-Clinical Formulation Analysis Support.

Scientist meticulously placing samples in an analytical instrument, illustrating our detailed pre-clinical formulation analysis support for enhanced drug development.

Navigating the complexities of drug development requires precise understanding and control over every variable, notably the exact dosage administered during pre-clinical studies. Alderley Analytical provides formulation analysis support that addresses this challenge and ensures the accuracy and regulatory compliance of dosages in drug formulations. Our GLP-compliant formulation analysis support helps our clients understand the doses administered and streamlines their path to regulatory submission.

The Importance of Pre-Clinical Formulation Qualification

Regulatory pre-clinical formulation quantification refers to the process of determining the precise concentration of a test substance in a drug formulation dosed in pre-clinical studies. This quantification is essential for many reasons, it provides important information to help the pre-clinical experts understand the actual dose administered to a pre-clinical species to help with dose vs exposure understanding.   This is a requirement in regulatory submissions and keeps compliance with pre-clinical testing requirements.

During pre-clinical studies, there is a requirement to provide accurate information about the formulation used, including the exact measurement of the test substance present.   This information is crucial for evaluating the drug candidate’s safety, efficacy, and pharmacokinetics.

Alderley Analytical’s Comprehensive Formulation Analysis Process

Our pre-clinical formulation analysis process typically involves the following steps:

#1 Method Development: Crafting Precision in Analysis

A suitable analytical method is developed to quantify the test material in the formulation accurately.   This method can involve techniques such as high-performance liquid chromatography (HPLC) or ultra-performance liquid chromatography (UPLC) connected to either an ultraviolet (UV) or mass spectrometer (MS) detector. 

#2 Validation: Ensuring Reliability and Accuracy

The developed analytical method is validated to ensure its accuracy, precision, specificity, linearity, and robustness. Validation ensures that the method is reliable and provides consistent results.   It is of particular importance to check for non-specific binding on the dosing vessel and investigate the most appropriate materials needed to achieve successful validation.

#3 Stability: Guaranteeing Formulation Integrity

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

#4 Sample Preparation: The Foundation of Accurate Analysis

The drug formulation samples are prepared for analysis. This may involve extraction of the test material from the formulation matrix, followed by appropriate sample clean-up and concentration steps.

#5 Advanced Analysis Techniques

The prepared samples are then analysed using the validated analytical method.   The method allows for the quantification of the test material.   The analysis will contain standards and quality control (QC) samples to check that the analytical batch is suitable and meets the pre-defined acceptance criteria.

#6 Data Analysis:  Translating Numbers into Insights

The obtained data is then analysed to determine the exact concentration of test substance in the formulation. This information is typically presented in a quantitative format, such as a value in milligrams per millilitre (mg/mL) or milligrams per gramme (mg/g).

#7 Documentation and Reporting: Bridging Analysis with Regulatory Compliance

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.

Why choose Alderley Analytical for your Pre-Clinical Formulation Analysis?

Working with Alderley Analytical for pre-clinical formulation analysis ensures unparalleled precision and compliance with regulatory standards. Our expertise in advanced techniques like HPLC and UPLC, combined with rigorous validation processes, offers accurate and reliable quantification of test substances. This accuracy is crucial as regulatory pre-clinical formulation quantification ensures transparency and adherence to regulatory guidelines, allowing authorities to assess the safety and efficacy of drug candidates effectively. With our detailed documentation and tailored approach, we streamline your drug development process, facilitating a smooth transition to clinical trials.

Trust Alderley Analytical to elevate your project with bespoke, regulatory-aligned analysis support, ensuring your research meets every requirement for successful progression.

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