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