(Figure 1) Developing a new medicine takes an average of 10-15 years.

Production of pharmaceutical drugs is a long process of industrial-scale synthesis by pharmaceutical companies. The process of drug manufacturing includes a series of unit operations, such as milling, granulation, coating, tablet pressing, and other processes depending on the formulation of the drug. But, what is more important is drug development which is a crucial process that lasts 10 to 15 years.

Drug development is also a long and ongoing process. There are several steps that are considered. The first step is drug discovery and development, which means it involves discovery work. This step is about choosing a molecule, such as a gene or protein, to target with a drug (Sean Williams,2015). The drug developer must confirm that the molecule is indeed involved with the disease in question (Sean Williams,2015). After testing multiple drug molecules, the drug development company will choose those that have promises.

 The second stage includes preclinical testing, which is divided into two phases; in vitro and in vivo testing. In vitro testing examines the drug molecules interactions in laboratory setting. In vivo testing involves testing the drug on animal models and on living cell cultures. Food and Drug Administration –FDA  does not allow preclinical studies move into human trails without extensive data on safety (Sean Williams,2015). In this stage researchers will whittle thousands of drug molecule candidates down to between one and five (Sean Williams,2015). Preclinical testing lasts several years.

Step three includes clinical research. In this stage drugs are tested on people to make sure they are safe and effective. There are different phases. In the first phase there are 20 to 100 healthy volunteers or people with the disease or condition. This phase lasts several months and almost 70% of drugs move to the next phase (FDA, 2017).  In the second phase of clinical trail the main focus is on efficacy and side effects. In this phase up to several hundred people with the disease or condition participate, and it lasts from several months to 2 years. Approximately 33% of drugs move to the next phase. In the third phase 300 to 3,000 volunteers having the condition participate in the study, and it lasts 1 to 4 years. Approximately 25-30% of drugs move to the next phase. In the last phase of clinical research several thousand volunteers participate to test safety and efficacy of the drug.

(Figure 2) In the end of the process, only one drug is approved for human usage

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 Step four includes FDA review and decision. The FDA has three choices: it can approve a drug; it can outright deny a drug; or it can revise the drug for the same characteristics all over again.

The fifth step consists of FDA post-market safety monitoring.

Thought, it takes an average of 12 years for a drug to travel from the laboratory invention to your medicine cabinet and be ready to use from people. Only 5 in 5,000, or 10% of the drugs that begin preclinical testing ever make it to human testing. Only one of these five is ever approved for human usage. Although there are routes that can expedite the process, this is the usual journey for a drug from invention to market.

 

COPYRIGHT: This article is property of We Speak Science, a nonprofit institution co-founded by Dr. DetinaZalli (Harvard University) and Dr. Argita Zalli (Imperial College London). The article is written by Elona Xhemaili (State University of Tetovo, Master of Pharmaceutical Sciences, Macedonia)

 

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