The Drug Development Process - FDA
Research for a new drug begins in the laboratory. Drugs undergo laboratory and animal testing to answer basic questions about safety. Drugs are tested on people to make sure they are safe...
Drug development - Wikipedia
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.
The 5 Drug Development Phases - Patheon pharma services
Oct 23, 2023 · New drugs must make it through five phases: discovery and development, preclinical research, clinical research, FDA review, and safety monitoring. Learn more about each drug development phase.
Development & Approval Process | Drugs | FDA - U.S. Food and Drug …
Get to know FDA’s drug development and approval process -- ensuring that drugs work and that the benefits outweigh their known risks.
Step 1: Discovery and Development | FDA - U.S. Food and Drug Administration
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.
DRUG DISCOVERY AND DEVELOPMENT: A STEP-BY-STEP PROCESS …
Apr 7, 2023 · Explore the drug discovery process from target identification to clinical trials. Learn the step-by-step process of developing new drugs.
What Are the 5 Stages of Drug Development? - University of …
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.
The Pathway from Idea to Regulatory Approval: Examples for Drug Development
For small-molecule drugs, the path to a marketed drug involves a long and exhaustive journey through basic research, discovery of the medicine, preclinical development tests, increasingly complicated clinical trials with humans, and regulatory approval by the Food and Drug Administration (FDA).
Drug Development | Clinical Center - National Institutes of Health ...
Bringing an investigational drug from bench to bedside is a long, complicated process involving many nonclinical and clinical investigations and layers of regulatory oversight. This page provides an easy-to-follow timeline for the life cycle of a new drug and detailed descriptions for the process.
The Drug Development and Approval Process | FDAReview.org
The process of getting a drug to market, from first testing to final FDA approval, is summarized in figure 1 and described at greater length below. Drug companies continuously analyze thousands of compounds, seeking ones of therapeutic value.