Analyzing the history of drug development from actual efficacy to mechanism of action

2021-03-22 18:07

Even with the development of science and technology today, the process of developing a new drug is extremely difficult. It takes about 20 years from research and development to market, and the average cost is about 1.5 billion US dollars...

"This long research and development journey is not only a pile of money and time, but also the crystallization of the wisdom and sweat of countless scientific researchers. From the flash of inspiration based on clinical needs to countless experimental attempts and failures in the laboratory, every step is full of challenges and uncertainties. Scientists first search for candidate drugs that may have an impact on specific diseases by extensively screening the compound library. This process is like looking for a needle in a haystack and requires a high degree of sensitivity and patience. Subsequently, the candidate drug needs to undergo rigorous in vitro experiments to verify its effect on cells or tissues, as well as preliminary toxicity assessment.

Entering the preclinical research stage, animal experiments on drugs become a key link, aiming to evaluate the drug in vivo The absorption, distribution, metabolism and excretion (ADME) of the drug, and the potential pharmacological mechanism of action are explored in depth. The data at this stage not only provides preliminary guarantee for the safety of the drug, but also lays the foundation for the subsequent clinical trial design.

When a drug passes many tests and enters the clinical trial stage, its safety and effectiveness will be systematically evaluated in different populations. From the small-scale safety test in the first phase, to the preliminary exploration of efficacy in the second phase, to the extensive verification in the third phase, each step is rigorous and meticulous. This stage not only tests the quality of the drug itself, but also tests the research team's strict compliance with ethics and regulations.

Therefore, the birth of a new drug is a combination of scientific exploration and humanistic care, and an important milestone for humans to fight against diseases and pursue health. Behind it are the efforts of countless scientific researchers day and night, as well as the desire and expectation of patients for a better life. "