Drug Development Lifecycle, Patents, and Global Health Access
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Pharmaceutical Research and Drug Development
6.1 Development of Medicines: Stages and Trials
The process of developing new medicines is typically divided into two main stages:
Stage 1: Discovery and Preclinical Trials
- This stage involves searching for substances that exhibit therapeutic activity against a disease while possessing minimal toxicity. This process is known as screening.
- Selected substances are subjected to in vitro tests. The most active candidates then undergo tests on animals to assess their response, efficacy, and safety profile.
Stage 2: Clinical Trials and Drug Safety Testing
The primary goal of this stage is to test the safety and efficacy of drugs in human subjects. It is conducted in four standard phases:
- Phase I: Reviews safety