The first edition of this now classic work helped to establish mass spectrometry as the premier tool for drug metabolism studies. Completely rewritten from start to finish, Using Mass Spectrometry for Drug Metabolism Studies, Second Edition brings medicinal chemists and mass spectrometry professionals up to speed with the rapid advances in the field, the emergence of cutting-edge approaches, and ways to meet steadily increasing vendor demands. Written by international scientists who are experts in their respective disciplines, this state-of-the-art reference effectively encapsulates current mass spectrometry best practices. The stand-alone chapters cover various topics - from metabolite identification to fast chromatography with UPLC - and in a style that is understandable to experts and field newcomers alike. The second edition of this bestseller includes coverage of new instrumentation and software as well as a wealth of updated information on the latest findings surrounding biomarkers and metabolomics and new chapters on both UPLC and DESI/DART. With more than 180 illustrations and an eight-page color insert, this valuable reference explores multiple modern mass spectrometry techniques and strategies. It includes an excellent overview of the entire drug discovery process plus the latest developments on how mass spectrometry is used to support this endeavor.

Essential principles and practice of assay development

The first comprehensive, integrated treatment of the subject, Assay Development: Fundamentals and Practices covers the essentials and techniques involved in carrying out an assay project in either a biotechnology/drug discovery setting or a platform setting.

Rather than attempting comprehensive coverage of all assay development technologies, the book introduces the most widely used assay development technologies and illustrates the art of assay development through a few commonly encountered biological targets in assay development (e.g., proteases, kinases, ion channels, and G protein-coupled receptors). Just enough biological background for these biological targets is provided so that the reader can follow the logics of assay development. Chapters discuss:

The basics of assay development, including foundational concepts and applications

Commonly used instrumental methods for both biochemical assays and cell-based assays

Assay strategies for protein binding and enzymatic activity

Cell-based assays

High-throughput screening

An in-depth study of the now popular Caliper's off-chip kinase assay provides an instructive, real-world example of the assay development process.

Completely revised, this second edition provides the practical, hands-on labeling information needed to secure rapid regulatory approval, gain marketplace acceptance, and assure user comprehension. A complete guide to all aspects of advertising, labeling, and packaging, it explains the relevant laws, regulations, and requirements in major markets worldwide and provides examples of compliance and noncompliance. Coverage includes requirements such as text, dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, over the counter products, in vitro diagnostic products, radiation emitting devices, contraceptive devices, and more.

Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.

Bayesian analyses have made important inroads in modern clinical research due, in part, to the incorporation of the traditional tools of noninformative priors as well as the modern innovations of adaptive randomization and predictive power. Presenting an introductory perspective to modern Bayesian procedures, Elementary Bayesian Biostatistics explores Bayesian principles and illustrates their application to healthcare research. Building on the basics of classic biostatistics and algebra, this easy-to-read book provides a clear overview of the subject. It focuses on the history and mathematical foundation of Bayesian procedures, before discussing their implementation in healthcare research from first principles. The author also elaborates on the current controversies between Bayesian and frequentist biostatisticians. The book concludes with recommendations for Bayesians to improve their standing in the clinical trials community. Calculus derivations are relegated to the appendices so as not to overly complicate the main text. As Bayesian methods gain more acceptance in healthcare, it is necessary for clinical scientists to understand Bayesian principles. Applying Bayesian analyses to modern healthcare research issues, this lucid introduction helps readers make the correct choices in the development of clinical research programs.

Teaching can happen anywhere, at any time - not just in classrooms but in churches, in bookstores, in homes, anywhere people get together to share ideas that affect their daily life. In Teaching Community, bell hooks shows how complex ideas of cultural theory can be simplified and made relevant to the lives of working people, and how the values of shared knowledge and learning can be a catalyst for progressive social change. Teaching - so often undervalued in our society - can be a joyous and inclusive activity and, as hooks shows, can never be confined to the classroom.

This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)

Since its initial publication in 1993, Development and Evaluation of Drugs from Laboratory through Licensure to Market has been used as a textbook and reference for scientists in biomedical research, industry, and regulatory agencies. Updated and expanded, this second edition examines recent advances in scientific and regulatory approaches as well as changes in the way in which drugs are discovered, developed, and evaluated. The information provided outlines critical steps beginning from drug discovery in the laboratory to licensure and approval for market.

Biomedical research is an intrinsically changing and evolving field. A more direct strategy for drug discovery has gradually replaced random screening of natural products. More rapid identification of key molecular structures for new drug candidates and characterization of biomolecules including proteins, polysaccharides, and nucleic acids are now possible. The ability to chemically modify cell surfaces and carbohydrate linkages has facilitated designs of the next generation of new drugs. Thoroughly discussing these issues and more, Development and Evaluation of Drugs from Laboratory through Licensure to Market, Second Edition focuses on the latest developments in the science and regulation of bringing new drugs to market, including activities of the International Commission on Harmonization.

This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations * EC and IPEC guidelines * ISO/BSI standards referenced in the checklists furnished in volume 1 Easy-to-read and organized to provide fast access to guidelines and regulations, this is an essential reference for those working in the field.

Pharmaceutical Chemistry:Therapeutic Aspects of Biomacromolecules offers a comprehensive and balanced introduction to this exciting and rapidly developing subject. Key strategies involved in the development and production of a range of clinically useful compounds are presented along with a broad overview of the way in which peptides, proteins, nucleic acids and carbohydrates are used therapeutically.

Illustrated with numerous examples, the book covers essential compounds and explains how they exert their influence through an understanding of biological processes. Pharmaceutical chemistry has become progressively more important in terms of both research and teaching, and this new book includes latest developments with examples carefully selected in order to emphasise the molecular basis of specific disease processes

Features:

• a comprehensive introduction to this evolving field
• numerous examples and problems focusing on fundamental concepts and ideas to enhance student understanding
• coverage of various strategies behind the development and production of a range of key clinically useful compounds

Integrated Drug Discovery Technologies provides a global overview of emerging drug development technologies by presenting and integrating new techniques from the disciplines of chemistry, biology, and computational sciences. It combines integration of contemporary mechanization with strategies in drug delivery. Topics include: functional genomics, microfabrication techniqes, integrated proteomics technologies, high throughput screening, and fluorescence correlation spectroscopy methods.

Pharmaceutical Process Validation, Third Edition explores the roots of pharmaceutical process validation originating in Switzerland and Germany in the 1980s. It covers troubleshooting procedures, validation in contract manufacturing, and harmonization trends. New chapters include Validation for Medical Devices, Validation of Biotechnology Processes, Transdermal Process Validation, Integrated Packaging Validation, Statistical Methods for Uniformity and Dissolution Testing, Change Control and SUPAC, Validation in Contract Manufacturing, and Harmonization, GMPs, and Validation. It includes contributions by research and industry specialists from the U.S., Europe, and Japan.

Furthering efforts to simulate the potency and specificity exhibited by peptides and proteins in healthy cells, this remarkable reference supplies pharmaceutical scientists with a wealth of techniques for tapping the enormous therapeutic potential of these molecules-providing a solid basis of knowledge for new drug design. Provides a broad, comprehensive overview of peptides and proteins as mediators of cell movement, proliferation, differentiation, and communication. Written by more than 50 leading international authorities, Peptides and Protein Drug Analysis discusses strategies for dealing with the complexity of peptides and proteins in conformational flexibility and amino acid sequence variability analyzes drug formulations facilitated by solid-phase peptide synthesis and recombinant DNA technology examines chemical purity analysis by high-pressure chromatographic, capillary electrophoretic, gel electrophoretic, and isoelectric focusing methods highlights drug design elements derived from protein folding, bioinformatics, and computational chemistry demonstrates uses of unnatural mutagenesis and combinatorial chemistry explores mass spectrometry, protein sequence, and carbohydrate analysis illustrates bioassays and other new functional analysis methods surveys spectroscopic techniques such as ultraviolet, fluorescence, Fourier transform infrared, and nuclear magnetic resonance (NMR) addresses ways of distinguishing between levels of therapeutic and endogenous agents in cells reviews structural analysis tools such as ultracentrifugation and light, X-ray, and neutron scattering and more! Featuring over 3400 bibliographic citations and more than 500 tables, equations, and illustrations, Peptide and Protein Drug Analysis is a must-read resource for pharmacists; pharmacologists; analytical, organic, and pharmaceutical chemis

This book addresses the use of food hydrocolloids as agents for encapsulating biological active ingredients. It details the challenges of poorly-controlled rate of hydration, thickness, decrease in viscosity upon storage, and susceptibility to microbial contamination. Food Hydrocolloids as Encapsulating Agents in Delivery Systems briefly describes various emerging biomaterials including food gums, starches, beta glucans, and proteins for their potential role as wall material in the development of nutraceutical delivery systems. Further, it describes different techniques of fabrication of nanodelivery systems. Features: Provides an introduction to food hydrocolloids as encapsulating agents Covers starches and their derivatives as delivery systems Includes gum-based delivery systems Discusses the classification, isolation, and purification of protein delivery systems This book would be helpful to food scientists and pharmaceutical scientists working in areas including nanotechnology, polymer chemistry, and nutraceutical delivery, as well as regulators and government researchers in US FDA, USDA, and UK FSA regulatory agencies.

Hepatitis C is a liver disease caused by the hepatitis C virus (HCV) and infects approximately 75 million individuals worldwide. It is also one of the major causes of liver cancer and liver transplants. The elucidation of the HCV genome, and the development of a whole cell system to study the virus spurred the search for novel direct acting antiviral drugs to cure this disease. This global effort culminated in the development of direct acting antiviral drugs that led to cure rates approaching 100% in all patient populations after only 8-12 weeks of therapy. These efforts resulted in one of the greatest achievements in public health and provides the potential for eliminating HCV as a major disease worldwide. This volume is aimed at a broad audience of academic and industrial scientists interested in the discovery and development of drugs to treat viral diseases and those interested in reading about one of the most unique accomplishments in biomedical research. The volume will provide a one of a kind reference work that highlights the many efforts, from the discovery of the HCV virus, to the invention of breakthrough medicines and their use in the real world to cure patients. It is the companion book to the volume "HCV: The Journey from Discovery to a Cure - Volume II".

"The most significant changes in isolation technology during the past five years have not been in the technology itself but in its increased acceptance. This acceptance is clearly demonstrated by the series of monographs, guidelines, and standards produced by regulatory bodies to describe best practice in the design and operation of isolators. Thoroughly revised and updated, Isolation Technology: A Practical Guide, Second Edition provides an in-depth overview of new standards and new technology. Here's what's new in the Second Edition: ""

This publication details the isolation of proteins from biological materials, techniques for solid-liquid separation, concentration, crystallization, chromatography, scale-up, process monitoring, product formulation, and regulatory and commercial considerations in protein production. The authors discuss the release of protein from a biological host, selectivity in affinity chromatography, precipitation of proteins (both non-specific and specific), extraction for rapid protein isolation, adsorption as an initial step for the capture of proteins, scale-up and commercial production of recombinant proteins, and process monitoring in downstream processing.

Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation practices. The book discusses how to clinical trial designs according to their probability for success, techniques to define distributions of virtual subjects' characteristics, methods to determine the sensitivity of the trial design, and the population relationship between dosing schedules and patient response.

As our understanding of the science and functions of color in food has increased, the preferred colorants, forms of use, and legislation regulating their uses have also changed. Natural Colorants for Food and Nutraceutical Uses reflects the current tendency to use natural pigments. It details their science, technology, and applications as well as their nutraceutical properties.

Starting with the basics, the book creates an understanding of physical colors, discusses color measurement, and analyzes why natural pigments are preferred today. The authors present an overview of global colorants, including safety, toxicity and regulatory aspects. Information about inorganic and synthetic colorants is included. The book then focuses on applications of natural colorants, with special attention given to characteristics, extraction and processing stability, and the use of biotechnology and molecular biology to increase colorant production. Finally, the book examines the nutraceutical properties of natural colorants and compares them to other well-known nutraceutical components.

From the basics to highly specialized concepts and applications, Natural Colorants for Food and Nutraceutical Uses presents essential, practical information about pigments in the food industry. With its coverage of state-of-the-art technologies and future trends in the application of color to food, this book provides the most comprehensive, up-to-date survey of the field.

Bioreactors: Animal Cell Culture Control for Bioprocess Engineering presents the design, fabrication, and control of a new type of bioreactor meant especially for animal cell line culture. The new bioreactor, called the "see-saw bioreactor," is ideal for the growth of cells with a sensitive membrane. The see-saw bioreactor derives its name from its principle of operation in which liquid columns in either limb of the reactor alternately go up and down. The working volume of the reactor is small, to within 15 L. However, it can easily be scaled up for large production in volume of cell mass in the drug and pharmaceutical industries. The authors describe the principle of operation of the see-saw bioreactor and how to automatically control the bioprocess. They discuss different control strategies as well as the thorough experimental research they conducted on this prototype bioreactor in which they applied a time delay control for yield maximization. To give you a complete understanding of the design and development of the see-saw bioreactor, the authors cover the mathematical model they use to describe the kinetics of fermentation, the genetic algorithms used for deriving the optimal time trajectories of the bioprocess variables, and the corresponding control inputs for maximizing the product yield. One chapter is devoted to the application of time delay control. Following a description of the bioreactor's working setup in the laboratory, the authors sum up their investigation and define the future scope of work in terms of design, control, and software sensors.

This book is devoted to a broader understanding of liposomes as a versatile tool used in many domains, including basic research and applied technology, focusing on less common applications and recent developments. Over the past few years, new types of liposomes made of nonphospholipid molecules have opened new perspectives in applications. These lipid vesicles, already used in cosmetology, are being manufactured for industrial and agricultural uses. However, "Stealth" liposomes, pH-sensitive liposomes, and cationic liposomes have enlarged and improved the application field of liposomes in clinical research. The book covers these different uses of liposomes with particular attention to new formulations and new applications.

Key features: The most comprehensive resource available on the biodiversity of algal species, their industrial production processes and their use for human consumption in food, health and varied applications. Emphasis on basic and applied research, addressing aspects of scale-up for commercial exploitation for the development of novel phytochemicals (phytochemicals from algae). Addresses the underexplored and underutilized potential of chemicals from marine sources for health benefits. Each chapter, written by expert contributors from around the world, includes Summary Points, Figures and Tables, as well as up-to-date references. The first book in this two-volume set explores the diversity of algal constituents for health and disease applications. The commercial value of chemicals of value to food and health is about $6 billion annually, of which 30 percent relates to micro and macro algal metabolites and products for health food applications. This comprenhensive volume looks in detail at algal genomics and metabolomics as well as mass production of microalgae. As a whole, the two-volume set covers all micro and macro algal forms and their traditional uses; their constituents which are of value for food, feed, specialty chemicals, bioactive compounds for novel applications, and bioenergy molecules. Bio-business and the market share of algae-based products are also dealt with, providing global perspectives.

Novel Drug Delivery Systems for Phytoconstituents discusses general principles of drug targeting, construction material and technological concerns of different phytoconstituent in delivery systems. It focuses on the development of novel herbal formulations and summarizes their method of preparation, type of active ingredients, route of administration, biological activity and their applications. It dicusses therapeutic activities of plant derived chemicals, their limitations in clinical applications and novel drug delivery solutions to overcome them to provide better therapeutic effects with controlled and targeted drug delivery. Focus on drug delivery of phytomolecules Act as bridge between natural product scientist and clinical doctors Discusses mechanism of poor bioavailability of herbal molecules Increases awareness towards phytochemical efficacy Summarizes efficient novel delivery systems-based formulations. It extensively covers the applications of novel drug delivery systems including polymeric nanoparticles, solid lipid nanoparticles, nanostructured lipid capsules, liposomes, phytosomes, microsphere, transferosomes, and ethosomes. Some chapters are especially focused on anticancer phytodrugs, silymarin, andrographolide, berberine, and curcumin delivery with special emphasis on their application.

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval. New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance pharmacovigilance programs designed to prevent widespread safety issues legal issues surrounding the sourcing of foreign APIs the issues of counterfeit drugs updates on quality standards

Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors' experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusses differences in the work of a biostatistician in small pharma and big pharma. Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels. Describes some useful statistical background that can be capitalized upon in the drug development enterprise. Explains some hot topics and current trends in biostatistics in simple, non-technical terms. Discusses incompleteness of any system of standard operating procedures, rules and regulations. Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial. Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed. Discusses realistic planning of open-ended projects.