Consultant, Drug Safety
CurrentGoalsTo provide sponsors/employers with reliable drug safety date prior to lead compound selection, attract investors and initiation of costly GLP studies. During recent economical stagnation, it is only one smart approach. and initiation of costly GLP studies. The reliable data from exploratory studies is necessary to streamline and improve the lead compound selection or the GLP study design and save time and money in the process. The Safety Pharmacology Consulting may arrange studies in several established CROs sites as well can helps to built own, in-house program.The exploratory safety pharmacology and toxicity studies are conducted using small animals (rat or ferrets, rabbits or quinoa pigs for QT interval prolongation studies) and are not expensive and may be conducted in-house. Following data analysis, the drug doses are calculated for GLP (dog/primates) using the allometric scalling. The classical QTc interval prolongation may leads to false over or under estimation of drug safety, the QT interval dispersion analysis is a better alternative and it is recommended by FDA and ICH. The analysis may be performed in-house, using existing raw data, or based on results of exploratory study, the whole GLP study may be done in recommended CRO. For more information search the Safety Pharmacology Consulting site (http://www.cksafetystudy.com/401.html) or I-cardiac site (http://www.icardiac.com/index.htm). ServiceDesign and monitoring exploratory and GLP toxicity and safety pharmacology studies,QT interval dispersion analysis.Animal model development/validation.Allometric scalling.Investigator Site AuditStudy Design, Monitoring & Evaluation.Toxicology summaries for regulatory submissions and investor presentations.Training,