Drug Development Process
A Drug Development Process is a clinical therapy development process for medicinal drugs.
- Context:
- It can involve Drug Discovery, Drug Research, Drug Production, and Drug Distribution.
- It can involve Drug Development Regulation.
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- Example(s):
- Counter-Example(s):
- See: Pharmacology, Toxicology, New Drug Application, Regulatory Approval, Preclinical Research, Food And Drug Administration, Investigational New Drug, Clinical Trial, Regulatory Approval.
References
2023
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- A Drug Development Process is a clinical therapy development process for medicinal drugs that involves the various stages of research and development required to bring a new drug to market. The process can involve Drug Discovery to identify new drug candidates, Drug Research to determine the safety and efficacy of the drug, Drug Production to manufacture the drug for clinical trials and commercial distribution, and Drug Distribution to make the drug available to patients. The development process can also involve various regulatory requirements, such as clinical trial design and reporting, that must be met to obtain regulatory approval for the drug.
Some examples of drugs that have undergone the drug development process include the cholesterol-lowering drug Lipitor, the antidepressant Prozac, and the cancer drug Herceptin. In each case, the drug went through a series of stages, from initial discovery to final approval, before it was made available to patients.
Related concepts to the drug development process include pharmacology, which is the study of how drugs interact with the body, and toxicology, which is the study of the adverse effects of chemicals on living organisms. Other related concepts include clinical trial design, drug safety monitoring, and pharmacovigilance, which is the ongoing monitoring of drugs after they have been approved for use.
- A Drug Development Process is a clinical therapy development process for medicinal drugs that involves the various stages of research and development required to bring a new drug to market. The process can involve Drug Discovery to identify new drug candidates, Drug Research to determine the safety and efficacy of the drug, Drug Production to manufacture the drug for clinical trials and commercial distribution, and Drug Distribution to make the drug available to patients. The development process can also involve various regulatory requirements, such as clinical trial design and reporting, that must be met to obtain regulatory approval for the drug.