DRUG DEVELOPMENT PROCESS
INTRODUCTION
The drug development process is designed to ensure the innovative a new medicine are effective, safe and available professions in a student possible time.
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery.
It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug.
STEPS INVOLVED IN DRUG DEVELOPMENT PROCESS
Step 1 : Discovery and Development
Step 2 : Preclinical Research
Step 3 : Clinical Research
Step 4 : FDA Review
Step 5 : FDA Post-Market Safety Monitoring
Step 1 : Discovery and Development
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.
New technologies, such as those that provide new ways to target medical products to specific sites within the body or to manipulate genetic material.
How it is absorbed, distributed, metabolized, and excreted.
Its potential benefits and mechanisms of action.
The best dosage.
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 vitro
In vivo
These regulations set the minimum basic requirements for:
study conduct
personnel
facilities
equipment
written protocols
operating procedures
study reports
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.
On this page you will find information on:
Designing clinical trials
Step 4 : 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. The process includes the following:
Each member of the review team conducts a full review of his or her section of the application. For example, the medical officer and the statistician review clinical data, while a pharmacologist reviews the data from animal studies. Within each technical discipline represented on the team, there is also a supervisory review.
The project manager assembles all individual reviews and other documents, such as the inspection report, into an “action package.” This document becomes the record for FDA review. The review team issues a recommendation, and a senior FDA official makes a decision.
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. FDA reviews reports of problems with prescription and over-the-counter drugs, and can decide to add cautions to the dosage or usage information, as well as other measures for more serious issues.
REFERENCE
https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
https://en.wikipedia.org/wiki/Drug_development
https://www.slideteam.net/drug-discovery-and-development-process.html
Student Name: Dhamodhiram A
Student ID: 174/082023
Qualification: M.Sc., Biotechnology
e-Mail ID: dhamubiotech824@gmail.com
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