Drug Testing

Drug Testing and Development

  • Drug development is a complex and lengthy procedure that includes discovery and extraction, preclinical testing, clinical trials, and regulatory approval.
  • All new drugs have to be rigorously tested before they can be approved for use.
  • Testing involves an experimental phase and a clinical phase, which include several stages - preclinical testing, phase I, phase II, phase III, and phase IV clinical trials.

Preclinical Testing

  • Preclinical testing involves in vitro (test tube) experiments and in vivo (animal) testing.
  • Toxicity, dosage, efficacy, and side effects are main aspects that are explored in preclinical tests.
  • These tests aim to predict how the drug might behave in human beings.

Phase I Trials

  • Phase I trials involve a small group of healthy volunteers.
  • The primary aim is to determine the safety of the newly developed drug.
  • Various dosages are tested to establish a safe dosage range, and to identify side effects.

Phase II Trials

  • Phase II trials involve a larger group of participants who suffer from the condition the drug aims to treat.
  • These trials aim to assess the efficacy and the optimal dose of the drug.

Phase III Trials

  • In Phase III trials, the drug is tested on a larger scale on patients.
  • The aim is to monitor adverse reactions, and to further define the drug’s uses and dosage.

Phase IV Trials

  • Also known as post-marketing surveillance, in these trials the drug is monitored in larger, more diverse patient populations.
  • This phase identifies any long term side effects, uses, or treatments and how the general public responds to the drug.
  • Ethical considerations in drug testing include ensuring that the testing process is just, humane, and in accordance with clinical trial protocols
  • These ethical considerations extend to animal testing and voluntary human testing with informed consent.
  • Legal considerations include abiding by local and global pharmacological regulations and guidelines.