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Screening Methodologies For Drug Delivery


When drugs are created they must go through several stages in the development process before they are deemed safe and can be used for the general public. They must pass many tests and have critical studies to support them. With this the FDA can grant approval. The stages include the discovery stage followed by the characterization stage and the formulation stage. After this there are disposition and application as well as bioanalytical testing. When that is complete there are clinical trials to finalize and then the drug is ready.

The discovery stage starts with identifying the target and selecting a biochemical mechanism that will be used in the disease. There are thousands of molecules that need to go through screening and functional genomics before they can be used in a drug. During this process the molecules are tested for activity compared to the disease condition for which that particular drug is being developed.

Once one or more lead compounds are selected it is time to move to the product characterization phase. During this phase the molecule needs to be characterized by its shape and its size as well as its strengths and its weaknesses. It must also be characterized by its preferred conditions for maintaining bioactivity and function.

In the next stage a delivery and formulation must be developed in order to properly deliver the drug. The stability of the drug must be tested so that it can be properly stored and shipped while remaining non-toxic. The drug disposition phase focuses on the maximum concentration of the drug that can exist in the blood and the time at which the drug will disperse in the body. The application phase analyzes the safety and efficacy as well as the bioactivity of the drug. It is a preclinical stage that integrates acute studies as well as repeated dose studies and reproductive toxicity studies. Once these studies are completed it is time for the drug to undergo bioanalytic testing where quality control and quality assurance are used as well as methods for culturing and fermenting the drug.

The last step is the clinical trials. There are three types of trials. One is called the human pharmacology trial or the first clinical development phase. The second is called the therapeutic exploratory trial or the second clinical development phase. The third is called the therapeutic confirmatory trial or the third clinical development phase.

Once all of the phases are complete a drug is ready for FDA approval. The process is long and arduous especially when done correctly. However it is a great process that ensures every drug on the market is safe and efficient.

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