What Are the 5 Stages of Drug Development?

Understanding Drug Development

Bringing a brand-new drug to market can take over a decade and can cost roughly $2 billion. Though you see new drugs being advertised in the United States every day, each of those drugs has to pass through five key stages of the drug development process, outlined below. Each of these complex and multifaceted stages can take years, and each requires the help of many scientists, pharmacologists, lab assistants, and more along the way.

Looking at the 5 Drug Development Stages

Stage 1: Discovery and Development

There are many steps that take place before a drug can be tested. Researchers must first identify the molecule that creates the medicinal effect in the first place, then develop the drug compound itself. The new drug is only ready to move into the preclinical research phase once it has been assessed for absorption rates, recommended dosages, side effects or adverse events, possible interactions with other drugs, and many other factors.

Stage 2: Preclinical Research

The goal of clinical studies is to test a new drug on humans; the preclinical trial first tests the same drug on animals (“in vivo”) or in test tubes (“in vitro”) to determine if the drug is safe enough to move forward without causing harm. The FDA requires compliance with defined Good Laboratory Practices (GLP), which set standards for study conduct, personnel, facilities and equipment, protocols and procedures, reporting, and oversight.

The preclinical research phase also raises new questions, such as: How will the drug be administered? How stable is the drug? What effects does the drug have on the body? Once the preclinical research meets the Food & Drug Administration (FDA) standards for data quality, integrity, and reliability, the drug can move on to the clinical research phase.

Stage 3: Clinical Research

To quote the FDA, “While preclinical research answers basic questions about a drug’s safety, it is not a substitute for studies of ways the drug will interact with the human body.” Is your new drug safe and effective for humans? The FDA divides clinical research into four phases, known as the Investigational New Drug (IND) Process:

• Phase I: 20-100 healthy volunteers or individuals with the disease or condition (~70% of drugs move on)
• Phase II: Up to several hundred people with the disease or condition (~33% of drugs move on)
• Phase III: 300-3,000 people with the disease or condition (~25-30% of drugs move on)
• Phase IV: Several thousand people with the disease or condition

A drug must pass through each of these phases before moving on to the FDA; only a small fraction of drugs are deemed safe and effective enough to successfully enter FDA review.

Stage 4: FDA Review

Before receiving approval to manufacture any new drug, the drug must successfully complete all four phases of clinical research and be formally submitted to the FDA, either as a New Drug Application (NDA) or a Biologics License Application (BLA). A team at the FDA then reviews the application; the team includes project managers, medical officers, statisticians, pharmacologists, pharmacokineticists, chemists, and microbiologists. After reviewing the drug’s clinical research (patient outcomes, side effects, risk-benefit analysis, etc.), the FDA determines if the drug is safe and effective enough to manufacture and market.

Stage 5: FDA Post-Market Safety Monitoring

The process isn’t over once the drug is on the market! The FDA has several programs that continue to monitor a drug’s safety and efficacy while it interacts with the general population, and conducts routine inspections of the manufacturing facilities for compliance. The FDA also monitors drug advertisements to avoid misleading or false claims about the new drug.

Another post-market step is the move from patented drugs to generic drugs. These drugs must have the same dosage form, strength, safety, quality, performance characteristics, and intended use as the original sponsored drug; for this reason, they do not return to clinical studies to prove safety and efficacy.

Learn More About Drug Development with UC Online

Are you looking to expand your background in pharmacy, medical, nursing, biology, business, or similar fields? Or perhaps you are already working within the drug development process and/or clinical research and are ready to advance your education?

The University of Cincinnati’s fully online Master of Science in Pharmaceutical Sciences in Drug Development is ideal for students and working professionals interested in the complex processes and sciences behind the drug development process, including discovery, preclinical and clinical research, and review and monitoring through the FDA.

University of Cincinnati’s curriculum sequence introduces students to the entire process in order, from discovering and developing a drug to delivering it into a patient’s hand (and beyond!). Students leave the program uniquely prepared for careers at all stages of drug development, including the scientific, regulatory, and business aspects.

Frequently Asked Questions About Drug Development

What are the Five Stages of Drug Development?

The five stages of the drug development process are:

• Stage 1: Discovery and Development
• Stage 2: Preclinical Research
• Stage 3: Clinical Research
• Stage 4: FDA Review
• Stage 5: FDA Post-Market Safety Monitoring

What are the Five Stages of Drug Development?

The average drug development process, from discovery to patient, is 10-15 years.