Clinical Trial Drugs Regulations and Manufacture

Clinical Trial Drugs Regulations and Manufacture Thesis example
Undergraduate
Thesis
Finance & Accounting
Pages 42 (10542 words)
Download 0
Clinical trial drugs regulations and manufacture. Clinical trials are of great importance for many common reasons. …

Introduction

For instance if one treatment is effective in children, could if be equally as effective with adults. Trials confirm what treatments are being used safely and satisfactorily on individuals. There importance is limitless amongst the population of the medical world. For quite some time, clinical trials in the pharmaceutical industry have been regulated by several government bodies. These regulations are set forth by entities like the United States Food and Drug Administration (FDA), the European Medicines Agency (EMEA or EMA), the International Conference on Harmonization (ICH), and the Medicines and Healthcare products Regulatory Agency (MHRA), to name a few. These entities weigh a heavy collateral on how pharmaceutical companies transition medicines from ideal to market with the use of clinical drug trials. The severity of the clinical trial drugs process has a significant donation to the well being of humanity, but faults in production of medications that will suffice in the treatment of those it was produced to treat. James Bryce once said; “Medicine, the only profession that labors incessantly to destroy the reason for its existence”. In short drug trials are performed to adhere to safety regulations that conform to human health strategies. According to the United States National Institutes of Health Service clinical trials are “considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol” (Understanding Clinical Trials, 2007). In order to associate the importance of these trials, it has to be first comprehended as to where they have evolved from. Traditionally, clinical drug trials can be associated with pharmaceutical medicine. ...
Download paper
Not exactly what you need?

Related papers

One year clinical results of Er, Cr:YSGG laser application in addition to scaling and root planing with early to moderate period
This strategy is aimed at abating, if not eliminating, etiologic agents of the disease, like microbial film and subgingival calculus [14], and restoring periodontal attachment level through the reconnection of periodontal fibers with newly formed cementum [2,52]. For nonsurgical management of early to moderate chronic periodontitis, scaling and root planing (SRP) remains the traditional initial…
Clinical neural scaffold for olfactory ensheathing cells
It is known that UV can degrade polymer. Previous studies showed that UV wavelength of 250 nm can cleave poly (methyl methacrylate), a standard polymer to its monomer methyl methacrylate and gases (Srinivasan, Braren, & Casey, 1990). Increasing the duration of the sterilization also increased damage to the polymer structure (Shearer, Ellis, Perera, & Chaudhuri, 2005)Recently, UV has been shown to…
an MNE establishing a 100% owned Greenfield factory in thailand to manufacture compact sedans for australian and south east asia
In this essay we will conduct an investment analysis of Thailand. We will discuss political risk, social risk and economy risk of Thailand. All the discussion will help an MNE that is trying to establish a 100 percent owned Greenfield factory in Thailand to manufacture compact sedans for Australian and South East Asian customers. There are many factors that can affect the decision of the MNE and…
Banking Regulations And The Current Financial Crisis
Thus we can say that even a stable banking system with all proper regulations in place failed to stop such a financial crisis from occurring. The paper intends to trace out the reasons behind such a failure with the help of findings and analysis and the relevant steps undertaken for this. Reasons behind failure of banking regulations Economists and policy makers of various countries have tried to…
General Journal Entries, Ledger Accounts, Trial Balance, Income Statement, Statement of Owners Equity and Balance Sheet (Case of Amal Translation)
In simple definition, General journal is a statement where double entry bookkeeping are posted by debiting an accouting followed by a corresponding crediting of another accounting using the same amount (Carl, James and Jonathan, 2008). Both debited and credited amount should be equal to maintain the accounting equation. Based on the available accounting information system, an organization may use…
Issues in accounting for R&D investment - a perspective from the pharmaceutical industry
The companies operating in the pharmaceutical industry spend millions of dollars each year in the research and development expenditure so that they are able to devise new methods and medicine that are able to cure and provide sustenance to the human body from deadly diseases. From the financial perspective, the research and development expenditure forms an integral part of the financial statements…
Microfinance - how government regulations affect microfinance in Brazil
The governments of the nations have a crucial role to play from the regulatory and financing points of view. A lot of measures are required to make this form of financing a sustainable one. This requires the scope of the microfinance schemes to be further widened. There are several challenges that the governments of the countries opting for these kinds of schemes face. There is lack of mobility in…