Preclinical Studies & Clinical Trials

Introduction and Necessary of Preclinical Studies & Clinical Trials

The process of developing new drugs is always time-consuming and costly. Thorough in vitro and in vivo preclinical testing is essential to evaluate aspects of pharmacodynamics, pharmacokinetics, and toxicology for new drugs. To better mimic the complex mechanisms of human diseases, it is necessary to optimize current standard preclinical and clinical approaches.

Further clinical trials refer to the clinical studies on human participants. The data on dosage, safety, and efficacy can be obtained. Generally speaking, clinical trials must be approved by the health authority/ethics committee in the corresponding country/region before proceeding. According to statistics, only 10% of all drugs in human clinical trials become approved drugs.

From basic research to an approved drug. Fig 1. From basic research to an approved drug. (Honek, 2017)

Introduction of Preclinical Studies

Preclinical research aims to provide information about the safety and effectiveness of drug candidates before they are tested in humans. Furthermore, preclinical studies have to follow guidelines dictated by Good Laboratory Practice to ensure reliable results.

The Ideal Preclinical Models

Phases of Clinical Trials

Creative Biolabs has been a long-term expert in the field of drug discovery. As a pioneer and the undisrupted global leader, we offer a variety of products and services. If you are interested in our products or services, please do not hesitate to contact us for more detailed information.

Reference

  1. Honek, J. Preclinical research in drug development. Medical Writing. 2017, 26: 5-8.
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