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
网页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...
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.
Overview of preclinical research - ScienceDirect
网页2023年1月1日 · Preclinical research is an essential starting point for the development and evaluation of nearly all translational, clinically relevant medical interventions. Understanding the underlying components of preclinical research is essential for designing robust experimental frameworks.
Preclinical testing—Understanding the basics first - ScienceDirect
网页2020年1月1日 · Preclinical testing or assessment is the interlink between drug discovery (i.e., bench—in vitro, in silico, in vivo—research and development, drug candidate selection) and clinical testing and ultimate availability of the drug product to the patient (i.e., bedside).
Overview of preclinical research - ScienceDirect
网页2023年1月1日 · Preclinical research encompasses all the investigations of a new intervention with the goal of evaluating the efficacy and safety of that intervention before implementation in humans. Preclinical studies are broadly divided into in vitro and in vivo studies, examples of which include cell culture experiments (in vitro) and animal models of ...
Harnessing the predictive power of preclinical models for ... - Nature
网页2021年10月26日 · In this Review, we outline issues in preclinical-to-clinical translatability of molecularly targeted cancer therapies, present concepts and examples of successful reverse translation, and...
Preclinical research | Nature Medicine
网页2023年4月24日 · Nanoparticle vaccines show promise in preclinical models; clinical evaluation is warranted to assess whether they could help reduce the burden of disease associated with EBV in humans.
Pre-clinical drug discovery - Nature
网页2023年3月23日 · Pre-clinical drug discovery lies at the intersection of many disciplines in the life sciences and showcases how advancements in these fields can contribute directly to the betterment...