The value the ICH Guidelines bring to the field of clinical research Essay

The value the ICH Guidelines bring to the field of clinical research - Essay Example The quality guidelines ensure maintenance of high quality in clinical research at all times. The guidelines provide harmonization procedures that are crucial for standardization of clinical research. The presence of standardization means it is easy to monitor factors that point to low quality. The quality guidelines provide the thresholds for testing and a relatively flexible approach to research that includes the use of pharmaceutical products (ICH, 2005). Quality guidelines ensure good manufacturing practices are implemented in the production of all pharmaceutical products. ICH guidelines support clinical research by availing detailed safety guidelines that increases the chances of success and limits injuries (ICH, 2005). The guidelines aid in identifying or unearthing potential risks, which include carcinogenicity, reprotoxicity, and genotoxicity. Recently, there was a breakthrough in a non-clinical testing strategy that is used to assess the QT internal prolongation liability. It is a signification contribution to the field of clinical research. The carcinogenicity studies provide safety guidelines on the use of rodents, the importance of carcinogenicity pharmaceuticals, prices, and any relevant issues that affect the performance of the drug. Safety guidelines help in maximizing success and minimizing failure and losses. Safety is among the foundational issues in matters concerning clinical research. Efficacy guidelines are all about conduct, design, safety and the reporting guidelines for clinical trials (ICH, 2005). They provide a benchmark that can be used to measure success or efficiency in the clinical research. The guidelines also touch on new drugs that have been made biotechnological procedures and the use of genomic techniques. These processes aid in the development of improved medicines. These guidelines have a huge impact on the safety of clinical