How Pharmaceuticals Make It to Market…

And where pharmacy technicians come in.

People use pharmaceuticals every day without giving much thought to where they come from. This article explores the pharmaceutical development process and provides insight into how today’s most frequently prescribed drugs make it from early development to your local pharmacy.

Step 1: Research

This is often the stage where initial breakthroughs happen. Whether companies want to develop a drug to fight cancer or cure the common cold, research and laboratory studies are where all drugs begin. *

Step 2: Determine safety and effectiveness

When manufacturers or potential marketers are thinking about bringing a new drug to the commercial market, the first questions they need to ask are: “Is this safe and is it needed?” From there, they will begin collecting data and necessary information to establish the drug’s safety and effectiveness. This typically happens through some form of animal testing.

Step 3: Submit an application to the Center for Drug Evaluation and Research

In the United States, pharmaceutical companies must gain permission from the federal Food and Drug Administration (FDA) to further develop and test potential drugs. This includes submitting an Investigational New Drug (IND) application and explaining the need for the drug, the animal pharmacology and toxicology studies, manufacturing information, clinical protocols and investigator information.

Step 4: Clinical trials

After submitting the IND application, pharmaceutical companies must wait at least 30 calendar days for the FDA to review it and give the go-ahead to begin clinical trials. At this stage, human testing can begin.

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Step 5: Review and approval

As soon as they conclude the clinical trials stage, pharmaceutical companies can begin examining the results. If the drug is determined to be safe and effective, the company will then submit a New Drug Application, which outlines the manufacturing specifications and other important information needed to bring the drug to market. After this review process is complete, the company may proceed with marketing its new drug for commercial use.

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Step 6: At the counter

This is where pharmacy technicians come in. They work on the front lines of distribution to the public. They ensure that proper medication, dosage and critical information about the drug are delivered to consumers to protect their safety.

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