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Development
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Drug development provides information on the safety and efficacy of new chemical and biological entities. This development information is collected by the performance of approved studies and clinical trials. Regulatory agencies, such as the FDA, require these development processes for a drug to be considered acceptable for long-term use.
Pre-Clinical Testing
When a new drug has been indentified in one of our laboratories, it begins the long process of pre-clinical testing which can take many years and cost millions of dollars. The new drug candidate is evaluated for safety and its ability to impact the disease for which it is intended. After the pre-clinical testing is complete, clinical studies are performed.
Clinical Trials
Clinical trials are used to assess the safety and effectiveness of a drug in groups of people. Clinical trials are performed in three phases:
- Phase I studies assess a drug's tolerance, pharmacokinetics (how a drug is absorbed, distibuted, metabolized and excreted), and its safety interactions.
- Phase II studies involve small patient populations exhibiting the target disease to assess its therapeutic effect on the disease, the optimal dosage, and its safety.
- Phase III studies involve large patient populations exhibiting the target disease to assess overall benefits and risks, additional safety and efficacy data, and to determine the basis for the drug's labeling.
- Phase IV studies are performed for post-marketing support so that quality and safety are continually monitored.