What Is Bioanalytical Support?

Bioanalytical Support services encompass critical analytical studies that enable the precise and reliable measurement of drugs, metabolites, biomarkers, and various analytes in biological samples. Bioanalytical analyses serve as a fundamental data source across numerous fields, ranging from drug development processes to toxicology studies, and from pharmacokinetic evaluations to bioequivalence studies.

These analyses, conducted on plasma, serum, whole blood, urine, tissue samples, and other biological matrices, contribute to understanding the behavior of test substances within the body and establishing their safety profiles.

At NanoTox, through our Bioanalytical Unit, we offer comprehensive bioanalytical support services using advanced analytical technologies, our team of experts, and infrastructure compliant with GLP (Good Laboratory Practice) principles.

The Purpose of Bioanalytical Support Services

The primary objective of bioanalytical studies is to ensure the accurate, precise, and reproducible measurement of target analytes in biological samples.

Through these studies:

• Systemic exposure levels are determined,
• Pharmacokinetic data are obtained,
• Toxicological evaluations are supported,
• Preclinical studies are strengthened,
• Regulatory requirements are met.

The data obtained contributes to critical decision-making in product development processes.

Why Is Bioanalytical Support Important?

The safety and efficacy of a drug or biological product depend on the accurate determination of actual exposure levels in the body. Without bioanalytical data, it is impossible to interpret pharmacokinetic and toxicological results.

Bioanalytical Support services are widely used, particularly in:

• Pharmacokinetic studies,
• Toxicokinetic evaluations,
• Repeated-dose toxicity studies,
• Safety pharmacology studies,
• Bioequivalence studies,
• Preclinical research

Analyte and Matrix ProfilesNanoTox laboratories are capable of performing analyses on a wide variety of biological matrices.The primary sample types analyzed include:Plasma,Serum,Whole blood,Urine,Tissue samples,CSF samples,Biological fluids.Analytical Techniques UsedAt NanoTox, bioanalytical studies are conducted using high-precision analytical platforms.The main methods used are:LC-MS/MSHPLCUPLCLigand Binding Assays (LBA)ELISAImmunochemical methodsBiomarker analysesThanks to these techniques, analytes at very low concentrations can be reliably measured.

Method Development and Method Validation Support

The success of bioanalytical studies is directly related to the reliability of the methods used. For this reason, NanoTox also conducts the development and validation of analytical methods.

Within the scope of these studies:

• Method development,
• Method optimization,
• Bioanalytical validation,
• Matrix effect evaluations,
• Stability studies

are carried out.

Studies Conducted in Compliance with International Guidelines and GLP Principles

Bioanalytical studies conducted at NanoTox are carried out in accordance with international guidelines.

Primary reference sources:

• FDA Bioanalytical Method Validation Guidance,
• EMA Bioanalytical Method Validation Guideline,
• ICH guidelines,
• OECD GLP principles.

Thanks to this approach, the data obtained meet international regulatory expectations.

Reliable Bioanalytical Support Services with NanoTox

NanoTox provides bioanalytical support services in accordance with international quality standards through its expert bioanalytical team, advanced instrumentation infrastructure, and GLP-compliant operational system.

We support product development processes by providing reliable bioanalytical data required for pharmacokinetics, toxicokinetics, safety pharmacology, and preclinical research.

Please contact NanoTox for detailed information about our bioanalytical support services.