Functional Studies with Human Isolated Tissues to Better Predict Clinical Safety and Efficacy
Complex Primary Human Cell Systems for Drug Discovery
Human in Vitro ADMET and Prediction of Human Pharmacokinetics and Toxicity Liabilities at the Discovery Stage
Utility of Human Stem Cells for Drug Discovery
In Silico Solutions for Predicting Efficacy and Toxicity
In Silico Organ Modelling in Predicting Efficacy and Safety of New Medicines
Human Microdosing/Phase 0 Studies to Accelerate Drug Development
Subject Index
Supplementary files
Publication details
https://doi.org/10.1039/9781782620136About this book
This book provides a history and discussion of the use of human tissues as an alternative to animal-based testing for assessing the efficacy and safety of new medicines. Beginning by providing a historical background to animal-based testing, this text then describes in detail the issues relating to access to human cells and tissue and the rules and regulations governing their use. The book illustrates what is currently possible in humanising medicines research and development, and suggests more rational and reliable means of developing safe and effective drugs for the future than those on which we currently rely. Early chapters establish the need to generate more data in human-derived test systems, and the need for resources such as tissue banks and standardised processes whilst highlighting the barriers that have prevented such developments so far. Subsequent chapters explore the alternatives to current animal toxicology studies, including stem cells and computational models, with balanced views of the technical challenges and opportunities these offer. In addition, useful information on computational methods and pharmacokinetics are included. This book is an essential read for anyone engaged in translational drug discovery who wishes to consolidate their understanding and broaden their awareness of the key issues involved in accessing primary human tissue and the advantages of doing so.