Process and Milestones of Drug Development
It takes an average of more than 10 years to develop a single new drug. The following research and development process will lead to the emergence of a new drug.
- Target molecule identification
- Identify a target molecule that is implicated in a disease process by understanding the real molecular mechanism of the disease.
- Seeds of drug
- Select candidate designed to specifically inhibit the action of a target molecule from several million seeds of drug.
- Verify optimal dose of candidate and method of using it.
- DMPK (Drug Metabolism and Pharmacokinetics)
- Research the process that a candidate is absorbed, distributed, metabolized and excreted by the body.
- GLP (Good Laboratory Practice)
- The practice for non-clinical safety assessments of the drug
- Phase I Clinical pharmacology (Healthy volunteer/Patient)
- Performed on a small number of healthy volunteers (or, for certain therapeutic fields and diseases, on patients) to assess the drug’s safety and the process by which it is absorbed, distributed, metabolized and excreted by the body.
- Phase II Exploratory/Confirmatory (Patient)
- Performed on a small number of consenting patients to determine the safest and most effective dosage and the dosing regimen.
- Phase III Confirmatory (Patient)
- Performed on a large number of consenting patients to confirm the efficacy and safety of the new drug in comparison with existing drugs or placebo.
- Preclinical studies
- A study to assess safety, efficacy and other characteristics of a drug using animal subjects.
- Clinical Development
- A study to assess the safety, efficacy and other characteristics of a drug in human subjects.