Clinical Pathology

GLP Compliance and Analytical Validation in Clinical Pathology

Clinical pathology is one of the fundamental disciplines that enables the quantitative and objective assessment of a test substance’s systemic effects in preclinical toxicity studies. This battery of tests, consisting of hematology, clinical chemistry, coagulation, and urinalysis parameters, is used to identify early markers of target organ toxicity, establish the dose-response relationship, and correlate observed histopathological findings with functional data. For these data to be accepted by regulatory authorities (OECD, FDA, EMA), not only must the analytical measurements be accurate, but the entire process—from sample collection through reporting—must be standardized in accordance with Good Laboratory Practice (GLP) principles and fully documented.

Nano-Tox Laboratory Services: Our clinical pathology laboratory, operating within our Pathology Testing Unit, is structured to meet these requirements and is supported by validated analytical platforms, approved Standard Operating Procedures (SOPs), and continuous quality control mechanisms.

Pre-Analytical Standardization: The Foundation of Data Quality

The reliability of clinical pathology data depends on a series of critical steps that begin even before the analytical measurement itself. Controlling pre-analytical variables is our laboratory’s top priority. In this context, the type of anticoagulant used during blood sample collection (such as EDTA, citrate, or heparin), the sample collection technique, the sample processing time, and storage conditions (such as the cold chain and protection from light) have been defined separately for each parameter and standardized via SOPs. Pre-analytical factors that could cause interference—such as hemolysis, lipemia, or jaundice—are documented for each sample and taken into account by the pathologist when interpreting the results. This meticulous approach ensures data integrity from the very beginning by minimizing variables that could compromise the accuracy of analytical measurements.

Analytical Platforms and Parameter Panel

The Nano-Tox clinical pathology laboratory is equipped with fully automated and validated analyzers. The installation, operational, and performance qualifications (IQ/OQ/PQ) of our devices have been completed, and system verification is performed at the start of each workday using commercial quality control materials at appropriate levels. The core analytical services offered in our laboratory include the following panels:

Hematology: Complete blood count (CBC), white blood cell differential, reticulocyte count, and red blood cell indices. Cytological evaluation of bone marrow smears is also performed upon request.

Clinical Chemistry: Liver function markers (ALT, AST, ALP, GGT, total bilirubin), kidney function markers (urea, creatinine, BUN), electrolyte panel (sodium, potassium, chloride, calcium, phosphorus), lipid profile, total protein, and albumin levels.Coagulation: Prothrombin time (PT), activated partial thromboplastin time (aPTT), and fibrinogen level.Urinalysis: Physical (color, specific gravity), chemical (pH, protein, glucose, ketones, bilirubin, urobilinogen, nitrite, leukocytes via dipstick), and microscopic sediment examination.

For each parameter, species-specific reference ranges (rat, mouse, dog, rabbit, etc.) have been established within our laboratory and are periodically updated. These species-specific reference ranges enable the accurate interpretation of the biological significance of the results obtained.

Data Management, Quality Control, and Regulatory Compliance

All clinical pathology data is transferred directly from the analyzers via a validated Laboratory Information Management System (LIMS), thereby eliminating manual transcription errors. Internal quality control (IQC) procedures, conducted concurrently with each analytical run, continuously monitor the accuracy and reproducibility of measurements. Our laboratory also independently verifies its analytical performance through international external quality assessment (EQA) programs in which it participates periodically.

All raw data, quality control records, and final results tables generated by the Nano-Tox clinical pathology laboratory are archived as raw data in accordance with GLP principles and made available to the study director. Clinical pathology results are integrated by the study’s responsible pathologist with histopathology findings and in vivo observations and presented in the final study report along with a comprehensive toxicological interpretation.

When you need clinical pathology data for your preclinical studies that is fully compliant with regulatory standards, analytically reliable, and enriched with expert interpretation, the Nano-Tox Pathology Testing Unit is ready to serve you in this regard.