Preclinical development - Wikipedia
网页In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.
Step 2: Preclinical Research | FDA - U.S. Food and Drug Administration
网页The two types of preclinical research are: FDA requires researchers to use good laboratory practices (GLP), defined in medical product development regulations, for preclinical laboratory...
General Principles of Preclinical Study Design - PMC
网页2020年1月1日 · In this chapter, we will focus on hypothesis testing type of preclinical studies and explain general concepts and principles in relation to the design of in vivo experiments, provide definitions of experimental biases and how to avoid them, and discuss major sources contributing to experimental biases and how to mitigate these sources.
General Principles of Preclinical Study Design | SpringerLink
网页2019年11月10日 · In this chapter, we will focus on hypothesis testing type of preclinical studies and explain general concepts and principles in relation to the design of in vivo experiments, provide definitions of experimental biases and how to avoid them, and discuss major sources contributing to experimental biases and how to mitigate these sources.
Design and Conduct Considerations for First‐in‐Human Trials
网页2018年8月24日 · The aim of this publication is to serve as a tutorial for conducting FIH trials for both small molecule and biological drug candidates with topics covering regulatory requirements, preclinical safety testing, study design considerations, safety monitoring, biomarker assessment, and global considerations.
Preclinical research - Latest research and news - Nature
网页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...
The role of early-phase trials and real-world evidence in drug
网页2024年2月15日 · Basic science studies are used to identify molecules that are likely to have clinical benefits. Early preclinical studies provide data on pharmacology and pharmacodynamics, toxicology,...
Overview of preclinical research - ScienceDirect
网页2023年1月1日 · While clinical research refers to studies in humans, preclinical research encompasses the body of research that lays the groundwork for ethical justification of human trials. In this chapter, we will focus on hypothesis-testing in preclinical studies, explain general concepts related to types of experiments and the design of in vivo experiments ...
Harnessing the predictive power of preclinical models for …
网页2021年10月26日 · In this Review, we provide suggestions to enhance preclinical to clinical translatability by reviewing examples of successful reverse translation, highlighting the utility of aligning...
Types and Phases of Clinical Trials - American Cancer Society
网页Doctors use clinical trials to learn whether a new drug, treatment, or combination works and is safe to use for people. Clinical trials are important in developing new treatments for serious diseases like cancer. All new treatments must go through clinical trials before being approved by the Food and Drug Administration (FDA).