At CUREX, we know that developing a safe and effective drug relies on understanding how it works or behaves in the body; only bioanalytical testing and method validation can deliver this outcome. Bioanalytical testing and method validation are two pillars of drug development that support the values of accuracy, reliability, and regulatory compliance. In this blog, we will define bioanalytical testing, review the definition of method validation, and discuss how CUREX as a bioanalytical contract research organization can help you develop your product from drug discovery to market.
What is Bioanalytical Testing?
Bioanalytical testing is vital to understanding a drug’s movement through the body. It includes measuring drug and metabolite concentrations or monitoring related biomarkers from biological matrices (blood, plasma, serum, urine, or cerebrospinal fluid). Bioanalytical testing is indispensable for understanding a drug’s pharmacokinetics (its movement through the body) and its toxicokinetic (its potential toxicity), and this information allows decisions to be made throughout development.
Why is this critical? The concentration of a drug affects both its efficacy and safety. If the concentration is too low, it may fail to provide any therapeutic effect, and if too high, it could have serious consequences for patients. Bioanalytical testing supports the ability for researchers to determine the correct dosages, and also monitor the disposition of the drug in humans from discovery- to- clinical trials and beyond.
At CUREX, we are able to support bioanalytical testing at any stage of the drug development process:
Figure 1: Phases of Bioanalytical Testing
- Discovery Phase: Non-GLP analysis for characterization of drug behaviour (biomarkers) and to determine dosing and toxicity
- Preclinical Phase: GLP-compliant pharmacokinetics and toxicokinetics studies to facilitate IND submissions
- Clinical Phase: The most rigorous sample analysis under GxP-compliant systems to ensure quality and data integrity during clinical trials.
The Importance of Bioanalytical Method Validation
In order for the bioanalytical tests to be reliable, the methods used must be carefully developed, and validated. The validation process assures the methods used to analyze biological samples are accurate, precise and reproducible. Validation of a bioanalytical method is important for producing credible data that is defensible by regulators and used to make important decisions in the development process.
Validation includes optimization of methods to fit our requirements around the following:
- Molecule type: small molecule, large molecule, novel therapeutic.
- Compound specificity: the exact molecular structure of interest.
- Biological matrix: the type of sample being tested e.g. plasma or urine.
- Calibration range: establishing the limits of detection, to ensure an accurate method.
- Anticoagulants: accounting for the biochemical agents used to preserve blood.
The FDA and the International Council for Harmonization (ICH) provide guidelines, for example, ICH M10, to standardize bioanalytical method validation. To ensure that methods are employed on strict criteria for reliability and performance. At CUREX, we have a vast library of validated, nonproprietary methods that will provide a shortcut for your project. If a new drug modality requires a new method, our experienced team can develop and validate a new method accurately and efficiently.
Why Partner with CUREX for Bioanalytical Testing?
Partnering with a specialized bioanalytical testing provider like CUREX offers significant advantages, particularly for companies racing against tight timelines or working with complex molecules. Here’s how we make a difference:
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Deep Regulatory Expertise
CUREX’s team ensures robust, compliant data for toxicology studies and clinical trials, staying ahead of evolving regulations to minimize regulatory hurdles during the IND submission phase.
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Cutting-Edge Automation
CUREX utilizes advanced automation in drug development, enhancing speed and accuracy in bioanalytical testing. Reducing validation timelines, ensuring consistency and precision in results.
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Extensive Method Library and Innovation
CUREX’s extensive library of validated bioanalytical methods allows for quick selection and adaptation. Saving time and ensuring project success, especially for groundbreaking drugs requiring custom approaches.
The CUREX Advantage in Drug Development
Bioanalytical testing and method validation are crucial for successful drug development, as they provide accurate data on drug behaviour in the body. CUREX offers expertise, technology, and regulatory know-how to support the journey from concept to regulatory submission. Partnering with CUREX provides access to resources and a commitment to success. Helping pharmaceutical companies and emerging biotechs unlock their full potential through tailored bioanalytical testing and method validation.
Ready to speed up your drug development? Connect with CUREX today to drive your project forward.
read also: What is Regulatory Considerations in Pharmacovigilance?
