Drug Discovery PROCESS

Drug discovery involves series of steps that are needed for launching a new drug in the market. Generally following basic steps are involved in discovery of new chemical moiety and launching it as drug in the market.

STEP 1: DRUG Discovery

Typically, researchers discover new drugs through:

• New insights into a disease process that 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 that 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.

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 Vitro
  
  
• In Vivo

FDA requires researchers to use good laboratory practices (GLP), defined in medical product development regulations, for preclinical laboratory studies.  The GLP regulations are found in 21 CFR Part 58.1: Good Laboratory Practice for Nonclinical Laboratory Studies. 

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
• Clinical Research Phase Studies
• The Investigational New Drug Process
• Asking for FDA Assistance
• FDA IND Review Team
• Approval

Designing of 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.

Step 4: FDA Review: 

If a drug developer has evidence from its early tests and preclinical and clinical research that a drug is safe and effective for its intended use, the company can file an application to market the drug. The FDA review team thoroughly examines all submitted data on the drug and makes a decision to approve or not to approve it.

New Drug Application:

A New Drug Application (NDA) tells the full story of a drug. Its purpose is to demonstrate that a drug is safe and effective for its intended use in the population studied.

A drug developer must include everything about a drug—from preclinical data to Phase 3 trial data—in an NDA. Developers must include reports on all studies, data, and analyses. Along with clinical results, developers must include:

• Safety updates
• Drug abuse information
• Patent information
• Any data from studies that may have been conducted outside the United States
• Institutional review board compliance information
• Directions for use

FDA Review:

Once FDA receives an NDA, the review team decides if it is complete. If it is not complete, the review team can refuse to file the NDA. If it is complete, the review team has 6 to 10 months to make a decision on whether to approve the drug. 

FDA Approval:

In cases where FDA determines that a drug has been shown to be safe and effective for its intended use, it is then necessary to work with the applicant to develop and refine prescribing information. This is referred to as “labeling.” Labeling accurately and objectively describes the basis for approval and how best to use the drug. 

Step 5: FDA Post-Market Safety Monitoring

Even though clinical trials provide important information on a drug’s efficacy and safety, it is impossible to have complete information about the safety of a drug at the time of approval. Despite the rigorous steps in the process of drug development, limitations exist. Therefore, the true picture of a product’s safety actually evolves over the months and even years that make up a product’s lifetime in the marketplace. 




HERE IS A QUICK VIDEO TO SUMMARIZE THE DRUG DISCOVERY PROCESS .