D.A. Wells: High Throughput Bioanalytical Sample Preparation

Abstract

Book’s topic The discovery and development of safe and effective new medicines is a long and complex process. Pharmaceutical companies typically invest 9–15 years of research and hundreds of millions of dollars in this effort. With the development of combinatorial chemistry and high-throughput pharmacological testing, the number of new drug candidates to be tested in preclinical drug metabolism has jumped dramatically. In order to screen drug candidates more efficiently in the early stages, cassette dosing and independent dosing of multiple drug candidates in pharmacological, toxicological, and pharmacokinetic studies have become increasingly popular. In these studies, speed of analysis and sample throughput is critical. Especially, sample preparation for biological fluids such as plasma, serum, or urine is rate-limiting. It is, therefore, important to develop a bioanalytical sample-preparation method with high-throughput capability in terms of the number of compounds and samples. The new book ‘‘High Throughput Bioanalytical Sample Preparation’’ provides a wealth of knowledge essential for sample preparation with high throughput (rapid productivity) in the field of drug development, covering a wide range of topics from the fundamental principles of various sample preparation techniques to strategies for method development and automation. Contents and critical assessment The book consists of 15 chapters. It begins with an introductory overview of bioanalysis in pharmaceutical drug development, focusing on activities performed at each stage of drug discovery, preclinical research, clinical development, and regulatory approval. Recent developments and industry trends in rapid sample throughput and data generation are introduced, together with examples of how high throughput needs are being met in bioanalysis. Specific roles of bioanalysis in screening of drug leads, metabolite identification, pharmacokinetics and therapeutic drug monitoring are also discussed. Chapter 2 reinforces the readers’ fundamental understanding of strategies for sample preparation and at the same time gives a preview of subsequent chapters on different techniques available to the bioanalyst. The author enables readers to master knowledge of the available tools needed to perform high-throughput sample-preparation techniques, with introductions and discussions on microplates (Chap. 3), accessory products (Chap. 4) and automation devices (Chap. 5). Selecting and using these high-throughput tools are thoroughly discussed. Particular strategies for efficient use of automation within a bioanalytical laboratory are also presented. The instruments available for automation of bioanalytical applications are discussed in three distinct groups: task-specific devices, liquid-handling workstations operating in a semi-automated or fully-automated mode, and application-specific workstations or systems. Next are reviews of four common sample-preparation techniques: protein precipitation (Chaps. 6 and 7),