Clinical research is an essential part of the drug development process, as it involves testing new drugs in human subjects to assess their safety, effectiveness, and side effects. Clinical research is typically conducted in three phases:
Phase 1: Phase 1 clinical trials involve a small number of healthy volunteers and are designed to assess the drug's safety and dosage. This phase typically includes a range of tests, including single and multiple dose studies, as well as pharmacokinetic (PK) and pharmacodynamic (PD) studies to determine how the body absorbs, distributes, metabolizes, and excretes the drug.- Phase
2: Phase 2 clinical trials involve a larger number of subjects with the
disease or condition being studied, and are designed to assess the drug's
effectiveness and side effects. Phase 2 trials are typically randomized,
controlled trials that compare the drug to a placebo or an active
comparator.
- Phase
3: Phase 3 clinical trials involve an even larger number of subjects and
are designed to confirm the drug's effectiveness, monitor side effects,
and compare the drug to other treatment options. Phase 3 trials are also
randomized, controlled trials and may involve several different treatment
arms.
After completing clinical trials, the drug's manufacturer
can submit a New Drug Application (NDA) to the appropriate regulatory agency
for review and approval. If the drug is approved, it can be manufactured and
marketed for use by patients. However, the drug's safety and effectiveness are
continuously monitored through post-marketing surveillance.
Tags:
Regulatory