Books in the Wiley Series on Pharmaceutical Science and Biotechnology: Practices, Applications and Methods series

The area of drug discovery has generated widespread interest, particularly with regard to the use of analytical technology for analysis. This book covers current analytical approaches, industry practices, and strategies in drug discovery. Analytical applications that require trace-mixture analysis are prominently featured.

The book highlights the current practices and future trends in structural characterization of impurities and degradants.

This book examines the background, industrial context, process, analytical methodology, and technology of metabolite identification. It emphasizes the applications of metabolite identification in drug research. While primarily a textbook, the book also functions as a comprehensive reference to those in the industry.

Due to its enormous sensitivity and ease of use, mass spectrometry has grown into the analytical tool of choice in most industries and areas of research.

This book covers the fundamentals, experimental procedures, and applications of dried blood spot (DBS) sampling in combination with various qualitative and quantitative analytical techniques. This includes sample collection, storage, transportation, and sample preparation for various analysis.

Presents Practical Applications of Mass Spectrometry for Protein Analysis and Covers Their Impact on Accelerating Drug Discovery and Development* Covers both qualitative and quantitative aspects of Mass Spectrometry protein analysis in drug discovery* Principles, Instrumentation, Technologies topics include MS of peptides, proteins, and ADCs , instrumentation in protein analysis, nanospray technology in MS protein analysis, and automation in MS protein analysis* Details emerging areas from drug monitoring to patient care such as Identification and validation of biomarkers for cancer, targeted MS approaches for biomarker validation, biomarker discovery, and regulatory perspectives* Brings together the most current advances in the mass spectrometry technology and related method in protein analysis

Specifically geared to personnel in the pharmaceutical and biotechnology industries, this book describes the basics and challenges of oral bioavailability one of the most significant hurdles in drug discovery and development.

The first book to offer a blueprint for overcoming the challenges to successfully quantifying biomarkers in living organisms The demand among scientists and clinicians for targeted quantitation experiments has experienced explosive growth in recent years.

Revised and expanded handbook provides comprehensive introduction and complete instruction for sample preparation in vital category of bioanalysis Following in the footsteps of the previously published Handbook of LC-MS Bioanalysis, this book is a thorough and timely guide to all important sample preparation techniques used for quantitative Liquid Chromatography-Mass Spectrometry (LC-MS) bioanalysis of small and large molecules. LC-MS bioanalysis is a key element of pharmaceutical research and development, post-approval therapeutic drug monitoring, and many other studies in human healthcare. While advances are continually being made in key aspects of LC-MS bioanalysis such as sensitivity and throughput, the value of research/study mentioned above is still heavily dependent on the availability of high-quality data, for which sample preparation plays the critical role. Thus, this text provides researchers in industry, academia, and regulatory agencies with detailed sample preparation techniques and step-by-step protocols on proper extraction of various analyte(s) of interest from biological samples for LC-MS quantification, in accordance with current health authority regulations and industry best practices. The three sections of the book with a total of 26 chapters cover topics that include: Current basic sample preparation techniques (e.g., protein precipitation, liquid-liquid extraction, solid-phase extraction, salting-out assisted liquid-liquid extraction, ultracentrifugation and ultrafiltration, supported liquid extraction, and sample extraction via electromembranes) Sample preparation techniques for uncommon biological matrices (e.g., tissues, hair, skin, nails, bones, mononuclear cells, cerebrospinal fluid, aqueous humor) Crucial aspects of LC-MS bioanalytical method development (e.g., pre-analytical considerations, derivatization strategies, stability, non-specific binding) in addition to sample preparation techniques for challenging molecules (e.g., lipids, peptides, proteins, oligonucleotides, antibody-drug conjugates) Sample Preparation in LC-MS Bioanalysis will prove a practical and highly valuable addition to the reference shelves of scientists and related professionals in a variety of fields, including pharmaceutical and biomedical research, mass spectrometry, and analytical chemistry, as well as practitioners in clinical pharmacology, toxicology, and therapeutic drug monitoring.

Bioanalytical Aspects in Biological TherapeuticsDeepen your understanding of how critical data are generated from bioanalysisIn Bioanalytical Aspects in Biological Therapeutics, a team of renowned chemists, immunologists, and biologists delivers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more.Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics. Alongside coverage of topics like PK, immunogenicity, neutralizing antibody assays, and the importance of quality control for reagents, readers will benefit from:* A thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics* Comprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies* Practical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays* In-depth examinations of critical reagents in bioanalysis* Regulatory expectations for bioanalytical method development, validation, and sample testingPerfect for pharmaceutical scientists in industry, Bioanalytical Aspects in Biological Therapeutics will also earn a place in the libraries of pharmaceutical regulators and other professionals working in pharmaceutical companies, as well as graduate students studying bioanalytical assays for biological therapeutics.