Selection of solvent and positive control concentration for enhanced Ames test conditions for N-nitrosamine compounds.

The Ames test is a widely used bacterial mutagenicity assay to evaluate the potential of chemical compounds to induce mutations. In recent years, there has been growing concern regarding the presence of N-nitrosamines in pharmaceuticals, food, and other consumer products. N-Nitrosamines are probable mutagens and carcinogens.

Safety Assessment of a Novel Intravenous Diclofenac Sodium Formulation Following 28-Day Repeated Administration in Wistar Rats.

These toxicity studies aimed to assess the safety and tolerability of a novel intravenous diclofenac sodium (37.5 mg/mL) formulation containing povidone K12 (80 mg/mL) as the key excipient in Wistar rats. This formulation was tested at doses of 3, 7, and 15 mg/kg/day and was administered daily for 28 days by intravenous route.

A Retrospective Comparison of Electrocardiographic Parameters in Ketamine and Tiletamine-Zolazepam Anesthetized Indian Rhesus Monkeys ().

Electrocardiographic evaluation is performed in rhesus monkeys to establish the cardiovascular safety of candidate molecules before progressing to clinical trials. These animals are usually immobilized chemically by ketamine (KTM) and tiletamine-zolazepam (TZ) to obtain a steady-state heart rate and to ensure adequate human safety. The present study aimed to evaluate the effect of these anesthetic regimens on different electrocardiographic parameters.

Comparison of different QT correction methods for nonclinical safety assessment in ketamine-anesthetized Indian rhesus monkeys ().

Rhesus monkeys are a non-rodent species employed in the preclinical safety evaluation of pharmaceuticals and biologics. These nonhuman primate species have been increasingly used in biomedical research because of the similarity in their ionic mechanisms of repolarization with humans. Heart rate and QT interval are two primary endpoints in determining the pro-arrhythmic risk of drugs.

Hematological and biochemical reference intervals of wild-caught and inhouse adult Indian rhesus macaques (Macaca mulatta).

Background: Nonhuman primates are used for research purposes such as studying diseases and drug discovery and development programs. Various clinical pathology parameters are used as biomarkers of disease conditions in biomedical research. Detailed reports of these parameters are not available for Indian-origin rhesus macaques.

Influence of estrous stages on electrocardiography, clinical pathology and ovarian weight of experimental beagle dogs: a retrospective analysis.

Estrous cycle is a repetitive phenomenon occurring during the reproductive life of a female dog. The duration of the canine estrous cycle is considerably longer than one in the most of the other animals and is broadly grouped into follicular phase (proestrus and estrus), luteal phase (diestrus) and non-seasonal anestrus. Dogs in the same stage of cycle can be inadvertently assigned to same group during routine safety and metabolic studies leading to possible erroneous interpretation of test-item related effects.

L. leaf extract alleviates doxorubicin induced cardiac stress.

Aim: The study was undertaken to evaluate the cardioprotective effect of the alcoholic leaf extract of L. against cardiac stress caused by doxorubicin (DOX).

Materials And Methods: Rats were treated with 100 mg/kg of leaf extract (MILE) in alone and interactive groups for 21 days.

Identification of appropriate QTc formula in beagle dogs for nonclinical safety assessment.

A number of drugs belonging to different therapeutic classes cause increase in QT interval duration, and this change has been associated with ventricular arrhythmias. Investigation of changes in QT intervals in toxicity studies in dogs is therefore of potential value. Estimation of a direct effect of drugs on the duration of the QT interval can be confused by drug-induced increases in heart rate.

Mangiferin protects rat myocardial tissue against cyclophosphamide induced cardiotoxicity.

Background: Mangiferin is a highly potent antioxidant present in mango leaves which is utilized for therapeutic purposes.

Objective: The present study was undertaken to evaluate the cardioprotective effect of mangiferin against cyclophosphamide induced cardiotoxicity.

Materials And Methods: Rats were treated with 100 mg/kg of mangiferin in alone and interactive groups for 10 days.