Preclinical development - Wikipedia
The main goals of preclinical studies are to determine a starting, safe dose for first-in-human study and assess potential toxicity of the product, which typically include new medical devices, prescription …
Step 2: Preclinical Research | FDA
After preclinical testing, researchers review their findings and decide whether the drug should be tested in people.
What Are Preclinical Studies and Why Are They Important?
Aug 20, 2025 · Preclinical studies are a fundamental early step in developing new medical innovations, such as medicines, vaccines, and medical devices. They occur in a laboratory setting, before any …
Preclinical vs Nonclinical: Key Differences Explained | GMP Pros
Oct 6, 2025 · Preclinical is narrower, focusing on the initial safety and efficacy work. Nonclinical is broader, covering all animal and laboratory studies throughout development.
Preclinical research - Latest research and news | Nature
Dec 17, 2025 · Preclinical research involves the evaluation of potential therapeutic interventions in cells and animals. Candidates for entry into clinical trials can then be selected based on their...
Preclinical vs. Clinical Research: Key Stages of Drug Development
In summary, preclinical research is a highly controlled, laboratory‐based process focused on safety and mechanism, whereas clinical research involves carefully regulated human testing of safety and efficacy.
Ultimate Guide to Preclinical Trials | Pharmacology Mentor
Dec 28, 2025 · While often simplified as “animal testing,” preclinical development is a highly regulated, scientifically rigorous process designed to bridge the gap between a chemical discovery and a …
Preclinical Studies in Drug Development | Process, Importance
Feb 14, 2025 · Preclinical studies refer to laboratory and animal testing conducted before human clinical trials. These studies aim to evaluate the safety, efficacy, and pharmacological properties of a drug …
Preclinical Studies in Drug Development: Foundations and Best Practices
Dec 21, 2025 · What are Preclinical Studies? Preclinical studies encompass a series of laboratory experiments and animal studies designed to collect safety, efficacy, and pharmacological data about …
Definition of preclinical study - NCI Dictionary of Cancer Terms
Research using animals to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies take place before any testing in humans is done.