Cardiac safety assessment is an important factor that all kinds of new drugs must be investigated before entering the clinical trial. It is also one of the most important and difficult links in the early clinical research of innovative drugs. In recent years, some drugs that have been put into clinical use have received widespread attention from drug safety regulators and drug companies because of their potential cardio toxicity.
As a one-stop pharmaceutical R & D integrated outsourcing service CRO Company, Medicilon has experienced team of experts providing from the cell to the whole animal multi-level clinical pre-cardiac safety evaluation services.
Efficient prediction of drug safety in early cardiac safety pharmacology, to reduce the potential adverse clinical response is particularly important and the current domestic can provide in line with GLP standards. There are few service companies can be used for IND declaration of heart safety assessment of one-stop pharmaceutical research and development. As one of the members, Medicilon’s services are as following:
Elucidating the adverse effects of non-acting target adverse reactions (ADR) and heterogeneity of the target response will help the compounds to avoid potential adverse reactions by subsequent in vivo experiments.
– Study on the mechanism of action of lead compounds
– Detection of cell levels
In Vivo Safety Pharmacology Research
The noninvasive telemetry system observes the changes in electrocardiogram and hemodynamics of whole animals and continuously monitors the effects of drugs on the cardiovascular system.
Advantages of Medicilon’s Cardiac Safety Assessment
– Cost-effective, short research cycle, project start fast
– The team of experts has a very rich experience in providing constructive solutions
– As a one-stop pharmaceutical R & D outsourcing service company, early to provide information on cardio toxicity assessment let Medicilon screen out the higher cardiac safety factor candidate compounds through chemical, pharmacodynamics, pharmaceutical and preparation of a set of technical means.
Drug safety assessment is an extremely important step in the drug development process, with some non-cardiovascular drugs have been found to induce acquired QT interval prolongation syndrome (LQTS), leading to severe arrhythmia and exit the market, Drugs on the safety of the heart has been more widely attention. The QT interval of the heart is a period of time from the beginning of the QRS complex to the end of the T wave, including the process of ventricular depolarization and repolarization. The prolongation of the QT interval is receiving more and more attention and is considered to be a new drug and one of the key indicators of safety evaluation.
In cardiomyocytes, human ether-a-go-go related gene (hERG) encoded potassium channels mediate delayed rectifier potassium current, which is the most important mechanism for drug-induced prolongation of QT. Due to its special molecular structure, and the hERG can be a variety of structural compounds to suppress. At present, the detection of compounds on the role of hERG potassium channel is not only a pre-clinical evaluation of the heart of the compound safety of the key steps, but also FDA requirements for new drug approval necessary information.