Pharmaceuticals - , ,
We effectively design protocols, initiate, monitor and report GLP and range-finding preclinical studies. If requested, we place studies with a reliable worldwide network of contract research laboratories (CROs). Our vast experience is utilized in placement and monitoring preclinical animal studies.Safety Pharmacology Consulting, LLC offers also Dynamic QT Interval Dispersion and T wave morphology analysis. The study may be conducted by recommended CRO or existing data may be analyzed (Dataquest® OpenART, .DSI files or PNM-P3-P-ECG®, .RAW files). The raw data is analyzed by Ponemah Physiology Platform software. The statistical analysis is performed using MATLAB software.Areas of Expertise:* Safety Pharmacology1. Core battery2. Beat to beat ECG analysis3. T wave morphology4. QT interval dispersion analysis5. Heart period variability (HPV) analysis* General Toxicology* Investigator Site Audit* Study Design, Monitoring & Evaluation* Study proposals, protocols and reports review* Inhalation Toxicology* Exploratory Toxicology and Safety Pharmacology* Safety assessment of the proposed lead compound.* Development of animal models of human disease* Toxicology summaries for regulatory submissions and investor presentations.* Training* Literature search