Got a tricky question? Receive an answer from students like you! Try us!

Drug Development Process - Essay Example

Masters
Author : glenrau
Essay
Science
Pages 6 (1506 words)
Download 1

Summary

Drug development is the process by which new therapies are created and brought to market to treat diseases. Drug should undergo a process before it will be able to approve by the Food and Drug Administration (FDA) and before it will be marketed. The Food and Drug Administration ensures the safety and efficacy of the drug being marketed…

Extract of sample
Drug Development Process


Each step should follow the guidelines provided by the Food and Drug Administration. Product for development which has been marketed or studied previously will undergo the same steps. According to the February 1993 report by the Congressional Office of Technology Assessment, one company costs $359 million in U.S. To be able to get one new medicine from the laboratory testing to the pharmacist's shelf, the process usually takes 12 years on the average and only 5 in 5,000 will make it to human testing. And only one of the 5 will be approved.(FDAreview.org)..
The first step is to analyze the target to be developed. Before developing a drug, you must identify first the state of the disease and the symptoms to which the development of drug will be base to. It is important to identify the target. The key decision if whether the target for therapeutic intervention is one that will have a positive effect on managing the disease in question. There are some companies who want to further develop their product. For example, a drug for diabetes will be developed; the company should specify what would be the added pharmacological action on their drug. This will be the basis for the clinical testing that the new product should undergo.
Metabolic pathway is a new approach in addressing and developing enhanced disease, understanding platforms with the potential to design si ...
Download paper
Not exactly what you need?

Related Essays

Engineering Design Process
Among the fundamental elements of the design process are the establishment of objectives and criteria, synthesis, analysis, construction, testing, and evaluation". (Engineering Design, 2006)…
4 pages (1004 words)
Pharmaceutical Industry Assignment
Antibacterial drugs have been the most effective of all medicines. Their success is reflected by their continued use and the decrease in morbidity and mortality from bacterial infections over the past 50 years. In recent years, however, the increase in the number of multidrug- resistant bacteria has led to the prediction that we are reentering the pre-antibiotic era. Even commonly occurring bacteria have been transformed into invasive and toxin-producing pathogens. New antibacterial drugs are needed to fulfill this unmet medical need.…
5 pages (1255 words)
Agricultural Development
An ongoing debate about the integration of farmers' empirical knowledge in agricultural development was sought to be answered by studying soil fertility management strategies in the Jos Plateau of Nigeria. The paper of Pasquini and Alexander (2005) tried to illustrate how farmers collectively can acquire considerable and detailed knowledge, which can be supported by scientific explanations.Since time immemorial, the idea that local people could have something to contribute to development is not always considered. Some scholars and scientists often put down local, indigenous knowledge. Often,…
6 pages (1506 words)
randomised clinical trials
The critical resource of D G Altman's "Practical Statistics for Medical Research" was also available at Google Books. Various search terminologies were used which include "Evolution/History/Review of Clinical Trials", "Ethical issues of clinical trials", "Nazi medical war crimes", "Nuremberg/Helsinki/Belmont" codes. Formulae for the sample size calculations were also accessed from journal publications and some power point presentation slides which have been cited and calculations were performed manually.…
19 pages (4769 words)
Brain Development
Brain functions through activity of neural circuits. These circuits are formed from the fetal period and throughout the life by forming synapses in a process called synaptogenesis. The necessary neutrons that a brain will have until death are almost present in a new born baby's brain. During the development stage 250,000 neutrons are added per minute. The brain grows after birth by increasing the size of the neurons and consequent increase in number of supporting cells. The weight of the brain of the newborn is approximately 300 grams. Brain weight increases with age and achieve mature weight…
3 pages (753 words)
How science should inform drug policy
It is proposed that there should definitely be more of the following: drug prevention for youth; drug intervention for young adults; and drug rehabilitation for older adults. This way, the prevalence of alcohol and drug abuse can be severely limited or possibly even eliminated to a certain extent in reaching out to various age groups. Drug policy in the UK definitely has the potential to be influenced by the scientific research that is being done by Robinson and Berridge, as well as George F. Koob and his own colleagues, too. Drug prevention for youth should be put into place in order to…
7 pages (1757 words)