The Complex Journey of Bringing a Drug to Market

🎯The drug development process begins with target identification, which involves finding a specific target for the drug, such as cancer cells or enzymes.

🧪New drugs can be discovered through various methods, including natural products, synthetic design, and high-throughput screening, which evaluates large numbers of potential drug molecules.

🔬Pre-clinical studies are conducted to assess drug absorption, distribution, metabolism, and excretion, as well as safety and appropriate dosage.

👥Clinical trials progress through three phases, involving volunteers with the targeted disease or condition to establish safety, efficacy, and optimal dosage.

📝After successful clinical trials, a new drug application is submitted to regulatory bodies for approval, which involves comprehensive data on animal studies, chemical compositions, pharmacokinetics, and study designs.

How long does it take to bring a drug to market?

—On average, it takes about 15 years from drug discovery to pharmacy availability.

What are pre-clinical studies?

—Pre-clinical studies involve evaluating drug absorption, distribution, metabolism, excretion, safety, and appropriate dosage using living cells, animals, and computer models.

What are the three phases of clinical trials?

—Phase 1 focuses on establishing drug safety in a small group of healthy volunteers. Phase 2 tests the drug's safety and efficacy in a larger group with the targeted disease. Phase 3 involves a larger-scale study to establish safety and efficacy.

What happens after clinical trials?

—Once clinical trials are completed and successful, a new drug application is submitted to regulatory bodies for approval. If approved, the drug can be marketed.

What is post-market surveillance?

—Post-market surveillance involves continuous monitoring of drugs and submission of long-term safety data to regulatory bodies. Consumers and practitioners can also report adverse drug events.

00:00The journey of bringing a drug to market is long and complex, involving target identification, drug development, pre-clinical studies, clinical trials, regulatory approval, and post-market surveillance.

02:17Pre-clinical studies assess drug absorption, distribution, metabolism, excretion, safety, and appropriate dosage using living cells, animals, and computer models.

03:31Clinical trials progress through three phases: Phase 1 establishes drug safety, Phase 2 tests safety and efficacy, and Phase 3 involves large-scale studies.

05:10After successful clinical trials, a new drug application is submitted to regulatory bodies for approval, including comprehensive data on animal studies, chemical compositions, pharmacokinetics, and study designs.

06:41Post-market surveillance involves continuous monitoring of drugs and submission of long-term safety data. Consumers and practitioners can report adverse drug events.