Pharmaceutical development stages
Here in BioSun Pharmed, science and ethical issues are the core of everything we do, from discovery to preclinical and clinical research and development till entering the market.
Our R&D focuses on the whole drug development pathway from process development, to non-clinical and clinical research. Our scientific expertise in combination with technological capacities enables us to develop new and affordable therapeutics. The strategy in BioSun is determined based on the latest medical needs.
Phases of Development
Drug discovery and development process is a highly structured and interactive and takes a lengthy period. The cost for developing a new drug averages $1.2 billion over 10 to 15 years.
To ensure the safety and effectiveness, a new medicine undergoes a long, complicated and controlled series of steps by applying high scientific standards including:
• Identifying a new approach/target to treat a disease
• Discovery and developing of new compounds that can affect a disease process
• Pre-clinical and animal study to determine the mechanism of action
• Clinical trials
New medicines must go through three phases of human testing under certain ethical views and all trial participants are free to withdraw from the trial at any time. All the clinical trials should meet the guidelines developed by the International Conference on Harmonisation (ICH), and the World Medical Association Declaration of Helsinki on the Ethical Principles for Medical Research Involving Human Subjects (2008).
In phase I clinical trials usually focus on safety by administration of low doses of an experimental medicine to a small number of healthy participants. In some cases, the first participants are patients with the disease that the experimental medicine is intended to treat. The dose is gradually increased to monitor and measure the clinical response to the medicine. At final it will be determined that how long the medicine remains in the bloodstream and which dosage levels are safe and well tolerated.
Focus of this phase is on the effectiveness of new medicine in treating a disease. The most effective dosage and route of administration are determined and much information on safety, side effects, and potential risks is gathered in this phase. In this phase, number of participants involved in the trials is increased typically up to several hundred participants. The patient participants are usually identified by physicians at research centers, clinics, and hospitals and enter the clinical trials.
In Phase III trials, several hundred to several thousand patient participants are involved in multiple centers and much additional information on the effectiveness and safety of a medicine is collected. These trials are often randomized and “double-blinded”.
To enter the market, new medicine should be in the health regulatory authority of a country in order to obtain approval. A complete report of the manufacturing process with quality data and trial results are provided to the health regulatory authorities in order to demonstrate the safety and effectiveness of the medicine. After approval, the new medicine can then be sold in the market for use by patients.
• Phase IV
"Post marketing studies" is the other name of this phase. Through this phase, additional information on long-term risks, benefits, and optimal use are collected. This phase involves thousands of patients and continues for many years.