Preclinical development - Wikipedia
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
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: FDA requires...
临床前研究 - 百度百科
临床前研究是指药物进入临床研究之前所进行的化学合成或天然产物提纯研究，药物分析研究，药效学、药动学和毒理学研究以及药剂学的研究。
一文读懂丨新药临床前研究制剂开发策略 - 知乎
2023年12月26日 · 新药研发主要分为四个阶段：新药发现（Drug Discovery）、临床前研究（Preclinical Research）、临床研究（Clinical Research）和新药申请（New Drug Application，NDA），不同开发阶段的研究对象与研究目标不同，…
Preclinical Study - an overview | ScienceDirect Topics
Preclinical studies are vital in establishing the efficacy and safety of a new chemical entity (NCE) in humans. To deliver meaningful information, experiments have to be well defined and provide outcome that is relevant and translatable to humans.
Preclinical Studies in Drug Development | PPD
Preclinical studies play a crucial role in the journey toward new drug discovery and development, assessing the safety, efficacy and potential side effects of a target compound or medical intervention before any testing takes place on humans. Such studies help researchers make informed decisions about progressing to clinical trials, paving the ...
Overview of preclinical research - ScienceDirect
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 …
临床前 - 百度百科
临床前（preclinical）是2014年公布的药学名词。 为拟开发的新药用于临床试验而开展的一系列实验室研究工作的总称。 包括合成工艺、提取方法、理化性质及纯度、处方筛选、制备工艺、检验方法、质量指标、稳定性、药理毒理、动物药动学等。 《药学名词》第二版。 [1] 临床前（preclinical）是2014年公布的药学名词。
Preclinical research - Latest research and news - Nature
2024年12月9日 · 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...
Ultimate Guide to Preclinical Trials | Pharmacology Mentor
2023年11月20日 · Preclinical trials are the cornerstone of medical research and development. They serve as the initial step in the long journey of bringing a new drug or medical device to market. The trials are designed to evaluate the safety, efficacy, and potential side effects of new treatments before they are tested on humans.