The Role of Bioanalysis in Drug Development
The Role of Bioanalysis in Drug Development
Bioanalysis, a specialized branch of analytical chemistry, focuses on quantifying drugs, metabolites, or biomarkers in biological matrices such as blood, serum, plasma, urine, or tissue samples. In drug development, bioanalysis is crucial for generating high-quality data necessary for advancing therapeutic candidates from the lab to clinical applications. Accurate quantification of pharmacological agents and their metabolites is essential in drug development.
Emery Pharma specializes in bioanalysis provides the data needed to understand the pharmacokinetics (PK) and pharmacodynamics (PD) of a drug, which are crucial for determining dosage, efficacy, and safety.
Emery Pharma is a premier contract research organization (CRO) specializing in mass spectrometry-based method development and validation, adhering to ICH M10 guidelines. Our expertise spans non-GLP and GLP sample analysis, supporting every stage of drug development. Utilizing advanced instrumentation, including High Resolution Orbitrap Mass Spectrometers and triple quad LC-MS/MS systems, and GC-MS systems, we deliver precise quantitation and characterization of a wide range of compounds. Our comprehensive services ensure accurate, reliable results, from method development to validation, facilitating the identification, purity assessment, and stability testing of pharmaceutical products.
Explore Our Solutions
Bioanalytical studies are critical in any drug discovery and development program. Studies that require bioanalytical support include bioavailability (BA)/bioequivalence (BE), non-clinical pharmacokinetics (PK)/toxicokinetics (TK), anti-drug antibody assays (ADA), and biomarker evaluation. Guidelines for these studies have been outlined by the FDA, ICH, EMA, and other global regulatory bodies.
Emery Pharma Can Help
with Your Discovery and Development Programs
Reliable bioanalytical assays require robust method development and validation. At Emery Pharma, we utilize sophisticated techniques to help our Clients’ with their bioanalysis needs in support of all stages of drug discovery and development programs.
What Are the Challenges in Bioanalysis?
For many scientists, bioanalytical method development, validation, and reporting may seem like a ‘black box’ – as it necessitates an intuitive understanding of how analytes behave in an ever-evolving complex biological matrix. Utilizing a customized approach, our team has the experience to face every challenge that comes our way. We are perfectly suited to handle all of the following challenging aspects about Bioanalysis.
We are happy to be the partnering lab for Clients requiring analysis for such hard-to-solve problems by sharing our extensive technical knowledge and experience. Please contact us today to learn more about our services and let us know how we can be your bridge to success on your next bioanalysis project.
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Robust Methods
Requirement for robust methods that work with many different sample types and background matrices, such as blood/plasma/serum, various tissues, and samples from both pre-clinical and clinical setting.
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Processing Unpredictable Samples
Processing samples derived from unknown genetic, metabolic, and dietary makeup, which pose unpredictability during analysis.
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Sophisticated Instrumentation
Employing sophisticated instrumentation such as triple quadrupole mass spectrometers that require specialized training.
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Adherence to GLP Guidelines
Submissions with phase-appropriately validated methods that adhere to GLP guidelines described in 21CFR58, Good Laboratory Practice for Nonclinical Laboratory Studies.
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Familiarity with Industry Standards
Familiarity with Regional differences in guidance and acceptance standards for various regulatory bodies (FDA in the United States, EMA in Europe, ANVISA in Brazil, etc.) that are updated regularly.
