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Drug Biotransformation In Clinical Trial Management

Posted by Doctor Dan on May 19, 2017 10:25:10 AM

The process of drug biotransformation has been carried out by complex enterprise formed on the basis of considering various elements including a plethora of research activities such as fundamental clinical research experience clubbed with a number of disciplines, processes, and technologies. It also takes diverse inputs referring to drug knowledge, disease knowledge, professional or personal affairs, regulatory/legal issues, marketing and business practices and medical factors in addition to global business. Health care issues play a predominant role in determining health care costs which are then utilized for the process of drug development. In fact, of late it has been determined that factors impacting healthcare utilization thrust a great force to refine the fluctuation in potential drug biotransformation in clinical trial management.

Challenges of drug biotransformation in healthcare industry

With respect to the degree of drug utilization, the issues concerning health care utilization are analyzed and addressed accordingly. There are some factors that may either increase or decrease the intensity of drug utilization impact affecting health care services i.e. the supply of health care services is measured based upon the number of surgery centers, hospital beds or physicians which directly leads to the modification of mix or type of drugs needed.

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Disease assessment is one of the major things to be taken into account for the biological assessment of drugs in clinical trial management. It is done adhering to the frameworks drafted by National Institutes of Health. Both antibiotic and antisecretory drugs will be considered for the purpose. This particular phase addresses various factors such as methods of treatment cures, public health advances, diseases with lower risk factors and a shift in sites of care. The biotransformation drug development is associated with some of the vital elements such as aging population, new technology, population growth, abundant use of prevailing drugs, the discovery of new drugs and frequent change in health policies. In general, the health care industry overview challenges are prone to diseases such as heart attack, stroke, breast cancer, disability rate and life expectancy.

Operations involved in clinical trials

As a lead to marketing application, the clinical trial activities correspond to activities that are required for conducting relevant clinical trial operations. It consists of several teams that are categorized and each team is allotted with specific tasks with respect to their expertise. However, it can be observed that the processes are found to be labour intensive, expensive and time-consuming. The operations are strongly regulated in correspondence with HIPAA, OIG, FDA and NIH to name a few. It also requires experienced investigating clinicians and volunteer patients. Often drug development is misconceived as the process to acquire accurate results. It is important to understand the feasibility and level of effort it takes to structure and bring order to processes that are not necessarily orderly. Another key scenario that should be considered here are the phases has huge demands for the deployment of SOPs and coordinated or integrated management systems.

In order to achieve the end result of drug biotransformation characteristics of products should have to be analyzed which is referred as clinical trial conduct. Though the initial stages will list only the successful combinations, at some point change over time is determined and more information from research is uncovered. Then the final product details for the specific research will be described in the product’s package insert. Once the package is done for a particular product, it has to be marketed according to its properties and description. Therefore a complete understanding of the product’s finished profile is mandatory. Patient care forms the core portion of the planning processes and it should be the foremost responsibility of any project team involved in clinical trial management.

Topics: Clinical Research