How Can an Idea Become a Drug?

A drug development is an extremely complex and time-consuming process that consists of several stages. Before a drug reaches the shelves of pharmacies, it must go through a long and strictly regulated path. This process requires the work of numerous scientists, researchers, and professionals who dedicate years to ensuring the drug’s efficacy and safety.

Laboratory and Animal Trials

The initial steps of drug development begin in the laboratory, where researchers define the targets aimed at treating the disease. During this step, it is crucial that the molecule being developed can effectively intervene in the disease process. With the advancement of the pharmaceutical industry, computer modeling has also played an increasingly significant role, allowing researchers to simulate the effects of molecules during the design phase. Subsequently, laboratory experiments are conducted to attempt to produce the desired molecule, which typically takes one to two years before animal trials commence.

In the preclinical phase of drug development, researchers examine the effects of the molecule through animal trials. These experiments are conducted according to strict ethical and scientific standards, aiming to determine how the molecule affects various organ systems. Tests performed on animals also help scientists understand the extent to which the molecule can influence the body’s functioning and what side effects may arise.

If promising results are obtained during the animal trials, researchers can transition to human clinical trials. This phase, which can take more than five years, is subject to stricter regulations, as the drug is tested on humans. Human clinical trials can be divided into different phases, each providing further information about the drug’s efficacy and safety.

Human Clinical Trials: Testing on People

Human clinical trials are typically divided into three main phases. In the first phase, researchers administer small doses, known as microdoses, to observe how the body reacts to the drug. These studies are conducted under strict hospital conditions, where researchers monitor the fate of the active ingredient in the body. This phase is critical, as it determines whether the drug is safe for the subjects.

In the second phase, researchers test the drug on larger groups and aim to demonstrate its therapeutic effect while determining the appropriate dosage. Here, researchers involve thousands of volunteers in the studies and analyze the effects of the molecule under controlled conditions. If favorable results are obtained during the trials, the next step is to seek approval for the drug’s market release.

The Drug Approval and Market Authorization Process

The approval process required for bringing a drug to market is extremely rigorous. Manufacturers must submit detailed documentation regarding the drug’s safety, efficacy, and management of side effects. The approval application is reviewed by the appropriate authorities, such as the National Institute of Pharmacy, and the drug receives market authorization only if it meets all criteria.

In the European Union, there are several types of approval procedures. In the centralized procedure, the drug receives a valid authorization throughout the EU, while in the national procedure, the authorization is requested for a specific country. The mutual recognition procedure allows a drug that has already been approved for market release in one member state to be recognized in other countries as well. Finally, the decentralized procedure enables simultaneous market authorization in multiple countries.

Thus, drug development is a long and complicated process that occurs within the strict frameworks of science, ethics, and regulation to ensure that the most effective and safest products are made available to patients.