Creation of Drugs: Preliminary Studies 

Most often, new drugs are developed from "the disease." Each disease is characterized by particular pathogenesis: some processes are happening abnormally. Specific molecules are overproduced, or not enough of them are being produced. Their function is disrupted due to gene "damage," or a pathogen reached the tissues and damaged it, causing a response. Thus, some molecules can be targeted to fix the problem. The scientists' main task is to find these targets and substances that can help influence their function. Often, a drug's target is the receptor – a protein on the cell surface that causes specific biochemical and physiological effects. It can also be a ligand — a signaling molecule, which links the receptor (or the DNA) and changes its activity.

A different strategy involves movement from "the potential drug." There is a substance with specific properties that could be helpful in medicine. The task is to find their application points. One example of a recently discovered potential drug is a compound in the spider's poison called Hadronyche infensa.

There is also a third "strategy" — the unexpectable. Sometimes, drugs are discovered unexpectedly. One of the best examples is probably a case that happened to the scientist that did not like to tidy up his laboratory, Alexander Fleming. On the 3rd of September 1928, upon returning from a vacation, a microbiologist noticed fungi grown in some Petri dishes that contained Staphylococcus, with the bacteria dead. This way, he discovered Penicillin, and the era of antibiotics begun.

Casting and Preliminary Checks 

So, there is an obvious need for the new drug; targets have been found, and the compounds that can target them. So, what comes next? Out of the potential drugs, the most suitable one is chosen. Its chemical structure is optimized to increase efficacy and safety, and various properties are being rated. Scientists perform experiments in cell cultures "in the test tube" (in vitro), in laboratory animals (in vivo), and by using computer modeling (in silico). At each stage, the questions asked are, "Is it worth continuing?" and "Is it worth it to invest time, money, and resources in the development of the new drug?"; If the answers are negative — the development is stopped.

All listed events are pre-clinical studies. Before starting trials that involve people, there is a need to thoroughly study all disadvantages of the drug: systemic and local toxic effects, effects on the male and female reproductive system, ability to cause hypersensitivity reactions, gene toxicity, or cancerogenic effects. The processes of drug administration, absorption, metabolic properties, and elimination are assessed.  

The directed development of the medicines is called drug design. However, it is not always possible to analyze all the details. For example, analysis of the drug's cancerogenic effect could take a long time and be in parallel with the clinical studies. It is essential that all process at the pre-clinical stage is thoroughly planned and are up to specific standards. To perform experiments on cell cultures and animals, scientists need to manufacture enough of the experimental drug. The Good Manufacturing Practice (GMP) helps to ensure the appropriate quality. This document contains the staff's requirements, equipment, technological process, recommendations for pollution prevention, mixing of various substances, and making mistakes.

Pre-clinical studies on animals are done according to the Good Laboratory Practice (GLP). 

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