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The Drug Development Process

Drug development is the process of bringing a novel drug from “bench to bedside”. ... Before a drug can reach a patient, it must go through rigorous testing to determine whether it is safe, effective at treating the condition it was developed for, and to ascertain the correct dosage and appropriate administration route.

There are 05 steps for Drug Development.

Step 1: Discovery and Development

Step 2: Preclinical Research

Step 3: Clinical Research

Step 4: FDA Drug Review

Step 5: FDA Post Market Drug Safety Monitoring

Step 1: Discovery and Development


Typically, researchers discover new drugs through:

  • New insights into a disease process allow researchers to design a product to stop or reverse the effects of the disease.

  • Many tests of molecular compounds to find possible beneficial effects against any of a large number of diseases.

  • Existing treatments have unanticipated effects.

  • New technologies, such as those that provide new ways to target medical products to specific sites within the body or to manipulate genetic material.

At this stage in the process, thousands of compounds may be potential candidates for development as a medical treatment. After early testing, however, only a small number of compounds look promising and call for further study.


Once researchers identify a promising compound for development, they conduct experiments to gather information on:

  • How it is absorbed, distributed, metabolized, and excreted.

  • Its potential benefits and mechanisms of action.

  • The best dosage.

  • The best way to give the drug (such as by mouth or injection).

  • Side effects or adverse events can often be referred to as toxicity.

  • How it affects different groups of people (such as by gender, race, or ethnicity) differently.

  • How it interacts with other drugs and treatments.

  • Its effectiveness as compared with similar drugs.

Step 2: Preclinical Research

Before testing a drug in people, researchers must find out whether it has the potential to cause serious harm, also called toxicity. The two types of preclinical research are:

  • In vivo

  • In vitro

Usually, preclinical studies are not very large. However, these studies must provide detailed information on dosing and toxicity levels. After preclinical testing, researchers review their findings and decide whether the drug should be tested in people.

Step 3: Clinical Research

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. “Clinical research” refers to studies, or trials, that are done in people. As the developers design the clinical study, they will consider what they want to accomplish for each of the different Clinical Research Phases and begin the Investigational New Drug Process (IND), a process they must go through before clinical research begins.

Designing Clinical Trials

Researchers design clinical trials to answer specific research questions related to a medical product. These trials follow a specific study plan, called a protocol, that is developed by the researcher or manufacturer. Before a clinical trial begins, researchers review prior information about the drug to develop research questions and objectives. Then, they decide:

  • Who qualifies to participate (selection criteria)

  • How many people will be part of the study

  • How long the study will last

  • Whether there will be a control group and other ways to limit research bias

  • How the drug will be given to patients and at what dosage

  • What assessments will be conducted, when, and what data will be collected

  • How the data will be reviewed and analyzed

Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies.

Clinical Research Phase Studies

  • Phase 1:

Study Participants: 20 to 100 healthy volunteers or people with the disease/ condition.

Length of Study: Several months

Purpose: Safety and dosage

Approximately 70% of drugs move to the next phase.