Interpretation of Clinical Pathology Results in Nonclinical Toxicity Testing

CHEMOPREVENTIVE POTENTIAL OF ALCOHOLIC EXTRACT OF A POLYHERBAL ( Phyllanthus amarus, Euphorbia hirta and Azadirachta indica) RECIPE AGAINST BENZO(a)PYRENE INDUCED LUNG CARCINOGENESIS IN ALBINO MICE

“…WBCs play a crucial role in the immune system by safeguarding the body against infectious diseases and foreign invaders. Therefore, the elevated WBC count in the treatment groups indicates that the polyherbal recipe employed in the study may possess immune-enhancing properties 88,89 . Furthermore, the LYM results indicate an enhanced defense mechanism in mice against tumor cell growth 90 .…”

Performance evaluation of the Sysmex XN‐1000V in side‐by‐side comparison with the Siemens ADVIA 120 and manual methods for healthy CD Sprague–Dawley rats and CD‐1 mice

“…Clinical pathology data are correlated with clinical observations; information from molecule absorption, distribution, metabolism, and excretion studies; anatomic pathology data; results of toxicokinetic and pharmacokinetic studies to determine the test article-related effects, dose-response relationships, onset, severity, and progression of test article-related effects; and regulatory requirements for further molecule development. [1][2][3] The CBC is the hematologic assessment performed most often in many types of safety assessment studies. The hematology instruments selected for use in biopharmaceutical organizations, contract research laboratories, and educational institutions conducting these types of studies need to be capable of analyzing blood from a variety of species, including mice, rats, rabbits, dogs, nonhuman primates, and pigs.…”

“…The instrument should be automated, capable of analyzing large numbers of blood samples daily, and require relatively small amounts of blood (≤250 μL EDTA whole blood). [1][2][3] The ADVIA 120/2120 hematology instruments (Siemens AG, Berlin, Germany) have been widely accepted for use in nonclinical safety and efficacy studies. 4 These instruments are used by numerous biopharmaceutical companies, contract research organizations, and university clinical pathology laboratories.…”

“…Hematology, hemostasis, clinical chemistry, and urinalysis form the minimal database for clinical pathology assessment in many types of acute and chronic studies involved in the safety assessment of new molecules in rodents, dogs, nonhuman primates, and people. Clinical pathology data are correlated with clinical observations; information from molecule absorption, distribution, metabolism, and excretion studies; anatomic pathology data; results of toxicokinetic and pharmacokinetic studies to determine the test article‐related effects, dose–response relationships, onset, severity, and progression of test article‐related effects; and regulatory requirements for further molecule development 1–3 …”

“…The hematology instruments selected for use in biopharmaceutical organizations, contract research laboratories, and educational institutions conducting these types of studies need to be capable of analyzing blood from a variety of species, including mice, rats, rabbits, dogs, nonhuman primates, and pigs. The instrument should be automated, capable of analyzing large numbers of blood samples daily, and require relatively small amounts of blood (≤250 μL EDTA whole blood) 1–3 . The ADVIA 120/2120 hematology instruments (Siemens AG, Berlin, Germany) have been widely accepted for use in nonclinical safety and efficacy studies 4 .…”