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The Drug Development Process That Pharmaceutical Products Go Through

Scientific research and technological developments can have powerful effects on individuals' lives and society's ways of providing services. For example, new knowledge in genetics is changing the way we think about risk of illness, kinship, and the ability to intervene in biological processes to change physical characteristics. Novel techniques for visualizing interiors of the body (such as functional MRI for brain imaging) and sensing chemical changes inside the body (such as biomem sensors) affect the way we classify and characterize "normal" function and behavior. The ability to grow cells into whole tissues using tissue engineering, or to invent new surgical procedures using telemedicine will dramatically transform the way therapies are delivered and medicine is practiced. At the same time, social, political and economic environments shape the form that innovations eventually take, by restricting or promoting certain research directions and funding. Consumer or patient advocacy groups may influence activity in certain areas, or controversies may erupt over innovations that seem to disrupt long-held cultural beliefs.

SCBE researchers study the interactions between science, technology and society, including emerging, unanticipated ethical and social concerns, the implications of changes in the way science is conducted (for example, patenting and commercialization issues) and implications of new technologies in terms of access and social justice, the way they may affect concepts of race and gender, and effects on clinical and basic research practice.

Most consumers are unaware of the drug development process that goes behind the medicines they take before these are released to the public. Unbeknownst to many, it actually takes 10 to 12 years and nearly $900 million before a pharmaceutical company could introduce a new drug to the public. It takes more than a decade to develop a new drug because the substances to be used in developing a pharmaceutical product must pass the pre-clinical and clinical tests, and these substances aren't only a few. Pharmaceutical companies often research and test thousands of different substances and compounds before a new drug could be successfully introduced into the market. Although it may seem like 10,000-30,000 substances are already more than enough, only about 30 compounds for every thousand will be able to show promising results, and only three compounds for every 30 will be able to pass the first round of clinical trials. Only after its component substances have gone through the clinical trials will a drug be viable for release in the market. There are many different phases that a drug goes through that contribute to the long time it takes to be developed. Discovery, pre-clinical testing, and toxicity studies alone take at least six-and-a-half years, and it takes an additional 7 years for it to go through Phase 1 through 3. Additionally, even after the substance has gone through a successful drug development, it may still undergo Phase 4 to test its safety and effectiveness, as well as to collect data from the results.

http://bioethics.stanford.edu