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Process

The primary purpose of developing new drugs is for disease prevention and/or treatment. However, behind each tiny newly constructed pill, there is huge amount of time and money investment: the development process for one single safe and effective drug, on average, takes 20 years and billions of dollars. This undoubtedly increases the barrier and requires the cooperation and efforts from government, academic institutes, pharmaceutical companies, and investors in all stages of drug development, in order to bring new drugs to the society.

There are several stages for drug development. Starting with basic scientific research, research institutes reveal the mechanisms and theories behind diseases, which helps identify potential drug “target” (normally refer to the gene or protein that has caused disease or transmission).

Secondly, scientists study how to interfere with these targets to control or eliminate disease. By testing thousands of compounds, only a few compounds that can inhibit or activate the targets can be selected, known as “active compounds”. Following that, repeated tests are conducted to confirm the effects of those active compounds, from which potential candidates are obtained through optimization process. To avoid side effects coming from the inactive interaction between screened compounds and target, researchers have to improve the absorption, distribution, metabolism, excretion, and toxicity (ADMET) properties of the compounds, and to select those safe and effective ones for further research and studies.

 

If preclinical results are promising , researchers will apply to the Food and Drug Administration (FDA) for clinical trial permission. A 3-phase (Phase I, II, III) clinical trial will be conducted after receiving FDA approval, to determine whether the drug will be approved for sale. Pharmaceutical companies play a significant role at this stage due to the high investment demand by clinical trials. Phase I is conducted among 20 to 80 healthy people, to assess the safety, safe dose, and side effects of the drug. During Phase II, 100 to 300 related patients will be recruited for preliminary evaluation of the therapeutic effect on target indications and for further safety assessment. Phase III will be conducted on 1000 to 3000 patients to further verify the therapeutic effects and safety of the drug on target indications, and to evaluate the balance between benefits and risks. The experiment is usually double blinded, with commonly used drugs or placebo as control. Phase III is the most critical step, because the more samples they have, the more statistically significant the results will be, and the more accurate the drug effect will be.

If Phase III clinical trial is successfully completed, pharmaceutical companies can apply to FDA for the drug to be sold in the market. All preclinical and clinical study data and series of materials that can approve the safety, efficacy, and quality of the drug should be submitted. This could make the application package up to hundreds of thousands of paper long. With the approval from FDA, the drug can be produced and sold for disease prevention or treatment.

However, the drug development process does not end yet, for FDA will continue to monitor the safety and effectiveness of the drug. Phase IV clinical trial will normally take place, to analyze the efficacy, adverse effects, long-term side effects, and drug use taboo in large population. If severe adverse effects that did not appear previously are observed during this stage, the drug could be at the risk of being removed from the market.

All of the above steps have indicated that the process of new drug development is significantly long and complicated. Undoubtedly, it has an extremely high demand for technology, talent, capital and time investment, in which a tiny mistake might result in incalculable consequences.

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