药物研发到上市过程

In drug research and development, the patient is the focus. The mission for nova is to help the patient overcome a disease and improve their quality of life. The drug development process is designed to ensure that innovative new medicines are effective ,safe and available for patients in the shortest possible time.

Chapter 1

Target Discovery

The first step in drug development is to discover the best targets for treating or prevent a disease. Targets are usually proteins in the patient’s body which are associated with the disease or proteins in microorganisms causing a disease. The challenge is to identify which proteins are relevant and more importantly confirm their role in a disease. Increasingly, nova focuses on understanding cellular networks of proteins or pathways. A single protein may transmit messages to several other proteins, sometimes in multiple pathways affecting their function. Knowing how these pathways work and interact helps to identify the most appropriate target for a drug. The pathway approach allows nova to better understand the mechanisms of a disease. This knowledge together with the desire to address unmet medical needs determines the primaries in target discovery.

Chapter 2

Drug Discovery

In drug discovery, several methods like high-throughput screening and computer-based design are used to find chemical compounds or biologics that bind to the identified target. If a compound modulates the target in a way that is expected to alter the disease. This so-called hit will be refined to improve its safety and effectiveness, eventually becoming a drug candidate. Discovering and bringing one new drug to the market typically takes an average of fourteen years of research and clinical development efforts and cost around two billion us dollars. Of 10,000 or more hits tested in early drug discovery only one may eventually lead to a drug that reaches the market.

Chapter 3

Safety and Drug Metabolism

In the late preclinical stage, further experiments are conducted on the drug candidate to ensure it is safe for patients and has the required pharmacokinetic properties like appropriate absorption and metabolism by the human body. These experiments are executed with extraordinary diligence to minimize any risks to human test subjects. Animals play a critical role in the drug discovery processes as well. Although much research and development can be done using various experiments or using computers, complex disease mechanisms can often only be understood though the use of animal studies. Also, governments and regulatory authorities require that medicines be tested in animals before they are tested in humans. Nova keeps this research as limited as possible had always ensures that animal research is scientifically acceptable according to current standards and regulations. For these reasons, nova continues to use animals in its quest to find innovative safe and life-saving medicines for patients. At the same time, nova is committed to refining, reducing and replacing the use of animals in research and upholding the highest standards in animal welfare.