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…
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 significantly more effective drugs against many human diseases, including cancer. (Schimdt , 2004). There are several factors that controls the level of drug in the individual patients, including environment, patient compliance and genetic differences. . The metabolic pathway will give insight on the possible kinetic problems that may occur by providing which specific enzyme the drug is metabolized. In this step the drug manufacturer will be able to identify the isozymes responsible for the metabolism in humans. Nowadays, there is several computer aided system in testing the metabolic pathways of a drug.
3) Molecular Specificity
In this step the molecules to be added in the drug should be specified for further analysis. Added molecules in a drug can alter the potency and efficacy of a drug. To be able to identify the molecules to be added, there are several new technology which can be of help to be able to shorten the period of this test. One molecule can affect the phamacological action of a drug, for example one molecule added to morphine can increase its painkilling effect.
4) Quantitative Structure-Activity Relationships (QSAR)
The Quantitative Structure - Activity Relationship or QSAR predict and analyze the drug activity. The QSAR represent an attempt to correlate structural or property descriptors of compound with activities. In QSAR the hydrophobicity, topology, electronic properties, and steric effects, are determined empirically, or more recently by computational methods. Activities used in QSAR include chemical measurements and ...
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(Drug Development Process Essay Example | Topics and Well Written Essays - 1500 Words)
“Drug Development Process Essay Example | Topics and Well Written Essays - 1500 Words”, n.d. https://studentshare.net/science/285591-drug-development-process.
They have given the meaning to life that did not exist prior to them. This was mainly because computing devices possess extremely fast calculating capabilities and imaging mechanisms as a result of which analysis of data has now become possible that could not have even been thought of before the advent of computers.
As the report stresses biologics can be found in vaccines, blood components and as living cells in therapeutic treatments. Biologics can be actual cells obtained from the body or other components such as sugars or proteins. Biologics is now finding a place in research studies as possible solutions for diseases that have not responded well to traditional drugs.
Pharmacokinetics as well as pharmacodynamics are related concepts of in pharmacology. Pharmacodynamics is the study of physiological and biochemical effects of drugs in the bodies of the disease causing microorganisms or parasites residing in other organisms. Drugs are chemical substances administered into the bodies of the organism in order to eliminate a pathogen thereby alleviating the discomfort resulting from such.
Care is therefore necessary in regulating all activities that lead to delivery and application of drugs by consumers. Legal measures exist and regulatory bodies have been instituted to ensure that developed drugs are safe for consumption. These measures however lack adequate preventive potentials and become active after breach. Internal measures that are based on moral principles and obligations would however guide drug developers and manufacturers towards ethical practice and this has the potential to prevent possible harm from development and dispensing of harmful drugs.
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Absolute specificity leads to less side effects and more effectivity. Understanding the physico-chemical basis of drug-target interaction is the challenging task for any drug development program. affinity of new drug molecule towards target can be evaluated based on various parameters like thermodynamics of interaction, availability of functional groups, Three dimensional structures and conformation , force acting on different bonds, pH and ionic strength dependent interaction etc.
Traditional drug development process is based on testing thousands of chemical compounds at several target sites in the body to produce a drug that could be used to treat all patients with a particular disease. However, with
Drug development is a gamble; one that involves spending billions of dollars and close to a decade before one can finally say that he has developed a drug that can actually cure a certain disease. Before a drug enters the market, it must undergo different processes that confirm it is fit for use on the patients for whom its developers purposed.
t of a minute molecule that functions like a drug, which is then moved on to the preclinical and the clinical stages of development if it is fruitful in the former stage. After which, it is approved and marketed as an appropriate drug. In the development process, a target has to
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