Clinical Pathology Services

Clinical Pathology Services

During early-stage drug development and research, clinical pathology involves biochemical analysis of biological fluids for safety, toxicity, and efficacy assessments of new drugs and medical devices. The fluid, primarily blood and urine, is obtained from the test animal model.

Regulatory bodies like the U.S. FDA and EMA require these specific fluid-based testing panels during preclinical safety assessments to get a comprehensive view of an organism's health. Clinical pathology typically focuses on the following three key areas:

Haematology & Coagulation:

Preclinical Haematology and Coagulation Panel are vital safety tests used to evaluate health and bleeding or clotting risks. These profiles can provide important information on treatment-related changes in circulating blood cells, bone marrow activity and haemostatic function.

Our capabilities include:

  • » Complete Blood Count

  • » Reticulocyte Count

  • » Erythrocyte Sedimentation Rate (ESR)

  • » Prothrombin Time

  • » Activated Partial Thromboplastin Time (APTT)

  • » Fibrinogen

  • » Clotting Time

  • » Bleeding Time

Clinical Chemistry:

Clinical chemistry involves performing biochemical assays and blood/urine/other body fluid analyses to evaluate the safety, toxicity, and efficacy of drug candidate and animal health research studies. This is done by measuring the key chemical and biochemical markers, related to hepatic, renal, metabolic, lipid and systemic responses during non-clinical studies.

Urinalysis:

Urinalysis is conducted to screen for kidney damage and systemic toxicity. It helps researchers monitor how candidate therapies impact renal function and urinary tract abnormalities. This includes evaluating pH and specific gravity; assessment of leucocytes, protein, glucose, erythrocytes and ketones; and urine microscopy

Thyroid Hormone Analysis:

Thyroid hormone profiling (Triiodothyronine, Thyroxine and Thyroid-Stimulating Hormone) is a battery of preclinical laboratory services used to identify potential treatment-related effects on thyroid function and the hypothalamic–pituitary–thyroid axis