Microbiologists working in both the pharmaceutical and medical device industries, face considerable challenges in keeping abreast of the myriad microbiological references available to them, and the continuously evolving regulatory requirements. The Handbook of Microbiological Quality Control provides a unique distillation of such material, by providing a wealth of microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. All the chapters have been written by leading experts in this field. The Handbook of Microbiological Quality Control provides guidance on safe microbiological practices, including laboratory design and sampling techniques. The design storage, use and quality control of microbiological culture is considered in depth. Principles of enumeration and identification of micro-organisms, using both traditional and rapid methods as well as the pharmacopoeial methods for the detection of specified organisms, are elaborated in detail. Guidance is given on laboratory methods supporting the sterility assurance system: sterility testing, bioburden testing, the use of biological indicators and environmental monitoring methods, as well as methods for detecting and quantifying endotoxins. Pharmacopoeial methods for microbiological assay and preservative efficacy testing are reviewed. Problems for those involved in disinfection and cleansing techniques and microbiological audit are discussed from a practical viewpoint. Finally, a number of pertinent case studies and worked examples illustrate problems highlighted in the text. The Handbook of Microbiological Quality Control is the essential reference source for the professional microbiologist.

The identification of the role of tumor stroma-the tissue in the surroundings of cancer cells-in cancer development, progression, and metastasis has revolutionized the fields of cancer biology as well as cancer therapeutics. This book provides a comprehensive overview of this rapidly-evolving field including tumor stroma biology, therapeutic targets, molecular imaging, and advanced tumor stroma in vitro models. The book will serve as a handbook for graduate students, postgraduate researchers, pharmaceutical scientists, and biomedical engineers.

Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields. Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.

Emphasizes recent advances in biotechnologies that will help in tackling emerging global health challenges Provides detailed information on how to harness indigenous bio-resources including microorganisms and plants for health care delivery Introduces new frontiers in the area of molecular diagnostics and DNA forensic science and bioinformatics with case studies, recent advances in medical insect biotechnology, molecular genetics of pest towards the exploitation of arthropod midgut components to develop interventions against infectious diseases Reviews bioactive molecules derived from commonly used and underutilized medicinal plants that could be used to develop novel drugs for improved healthcare delivery Discuss current approaches in medical and biopharmaceutical biotechnology, deployment of inexpensive genomics-based vector surveillance for effective disease outbreak prediction and control of mosquito-borne viruses

Key features include: Details the role of plants for the treatment and management of cancer and diabetes Discusses the role of phytocompounds as ligands for cancer and diabetic targets Reviews plants and the potential of phytochemicals as antidiabetic and anticancer drugs Explores the green biosynthesis of nanoparticles and their treatment efficiency

This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. Complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design. The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin). The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear. The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products. The Science and Regulations of Naturally Derived Complex Drugs addresses the interests among industry, academics, and government on the issues surrounding the future development of mixtures for medicinal use.

This book focuses on important decision points and evidence needed for making decisions at these points during the development of a new drug. It takes a holistic approach towards drug development by incorporating explicitly knowledge learned from the earlier part of the development and available historical information into decisions at later stages. In addition, the book shares lessons learned from several select examples published in the literature since the publication of the first edition. The second edition reiterates the need for making evidence-based Go/No Go decisions in drug development discussed in the first edition. It substantially expands several topics that have seen great advances since the publication of the first edition. The most noticeable additions include three adaptive trials conducted in recent years that offer excellent learning opportunities, the use of historical data in the design and analysis of clinical trials, and extending decision criteria to the cases when the primary endpoint is binary. The examples used to illustrate the additional materials all come from real trials with some post-trial reflections offered by the authors. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and decision making at different stages of drug development. Prior knowledge includes information pertaining to historical controls. To assist decision making, the book discusses appropriate metrics and the formulation of go/no-go decisions for progressing a drug candidate to the next development stage. Using the concept of the positive predictive value in the field of diagnostics, the book leads readers to the assessment of the probability that an investigational product is effective given positive study outcomes. Lastly, the book points out common mistakes made by drug developers under the current drug-development paradigm. The book offers useful insights to statisticians, clinicians, regulatory affairs managers and decision-makers in the pharmaceutical industry who have a basic understanding of the drug-development process and the clinical trials conducted to support drug-marketing authorization. The authors provide software codes for select analytical approaches discussed in the book. The book includes enough technical details to allow statisticians to replicate the quantitative illustrations so that they can generate information to facilitate decision-making themselves.

This book is a comprehensive review of thrombin, especially as regulatory protease. The ready availability of highly purified thrombin has stimulated rapid advances in the cell biology of this important macromolecule. The text focuses on research findings from the discovery of thrombin by Andrew Buchanan in 1842 to the present. A substantial amount of this work was conducted by the author and his colleagues. His work on the purification of thrombin was seminal to much subsequent work on thrombin. This volume provides a framework for future studies now made possible by the discovery of the importance of exosites in the physiology of thrombin function. The current work describes the process of the development of an oral inhibitor of thrombin used in the prevention of thrombosis. Key Features Reviews the history of Thrombin (Fibrin Ferment) Documents the relation of protein engineering and chemical modification in the study of thrombin Summarizes the interaction of thrombin with fibrinogen and fibrin Outlines the role of exosites in thrombin function Describes the development of an oral inhibitor for thrombin

Endotoxin detection and control is a dynamic area of applied science that touches a vast number of complex subjects. The intersection of test activities includes the use of an ancient blood system from an odd "living fossil" (Limulus). It is used to detect remnants of the most primitive and destructive forms of life (prokaryotes) as contaminants of complex modern systems (mammalian and Pharma). Recent challenges in the field include those associated with the application of traditional methods to new types of molecules and manufacturing processes. The advent of "at will" production of biologics in lieu of harvesting animal proteins has revolutionized the treatment of disease. While the fruits of the biotechnology revolution are widely acknowledged, the realization of the differences in the means of production and changes in the manner of control of potential impurities and contaminants in regard to the new versus the old are less widely appreciated. Endotoxin as an ancient, dynamic interface between lifeforms, provides a singular perspective from which to view the parallel development of ancient and modern organisms as well as the progress of man in deciphering the complexity of their interactions in his efforts to overcome disease.

The first and only book on Spray-freeze-drying" which is a relatively recent drying technique, that provides the signature advantages of spray-drying and freeze-drying, while overcoming the limitations of both. Provides examples and case studies of nuances and intricacies associated with each stage of the spray-freeze-drying process Contains 200+ illustrations and tabulations Highlights the applications of spray-freeze-drying in the production of food products including soluble coffee, dairy powders, probiotics, and flavors.

As the most common health-care intervention, prescription drug use shares the most important characteristics of the health-care system in the United States. When everything works well, it makes possible breathtakingly successful applications of science to the prevention and cure of human suffering. But everything doesn't always work well. Pharmaceutical Public Policy provides the understanding and framework required for effective organization, financing, and delivery of pharmaceutical products and services. It supplies an overview of the policy process as well as the roles of legislation and regulation in pharmaceutical policy. The book identifies the goals, objectives, and key policy issues of concern to stakeholders involved in the development of products, use of pharmaceuticals in healthcare, and administration of insurance programs by both the private and government sectors. Policy issues examined include the appropriateness of prescribing and patient adherence. Addressing questions of access, quality, and cost, the book considers the operation of the Affordable Care Act and Medicare Part D. It details the responsibilities of Federal providers of pharmaceutical care and private and public payers such as managed care organizations, pharmacy benefit managers, Medicare, and Medicaid. The book covers the policies and practices involved in promoting pharmaceutical products. It also considers pharmacoeconomics as a response to market failure. Finally, the book describes the market, the role of the manufacturer, drug shortages, and the responsibilities of the FDA. The book includes a Foreword by Jerry Avorn, MD, Professor of Medicine, Harvard Medical School; and Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Woman's Hospital.

This new volume, Natural Polymers for Pharmaceutical Applications, Volume 1: Plant-Derived Polymers, presents some of the latest research on the applications of natural polymers in drug delivery and therapeutics for healthcare benefits. Polymers and their applications from several plants are discussed in depth, including tamarind gum, gum Arabic, natural carbohydrate polymer gum tragacanth, pectin, guar gum and its derivatives, locust bean gum, sterculia gum, okra gum, and others. The use of the polymers derived from plants as potential pharmaceutical excipients is expanding day by day because of their stability in the biological system, drug-releasing capability, drug-targeting abilities, as well as their bioavailability.

Many polymers derived from various marine sources and microorganisms possess some important biological properties such as biocompatibility, biodegradability, and bioadhesivity that make them attractive as pharmaceutical excipients in various pharmaceutical dosage forms. Moreover, these polymers can be modified physically and/or chemically to improve their biomaterial properties. In this volume, Natural Polymers for Pharmaceutical Applications, Volume 2: Marine- and Microbiologically Derived Polymers, looks at how these polymers have been explored and exploited for pharmaceutical uses, such as in tablets, microparticles, nanoparticles, ophthalmic preparations, gels, emulsions, suspensions, etc. Some commonly used marine- and microbiologically derived polymers used as pharmaceutical excipients include alginates, agar-agar, gellan gum, carrageenan; chitosan, xanthan gum, and others. The book focuses on important recent advances from experts around the world on marine-derived polysaccharides and pharmaceutical applications of alginates, agar-agar, gellan gum, carrageenan, chitosan derivatives, xanthan gum.

In recent years, many animal-derived polymers have emerged as an attractive category of naturally derived polymers because of their advantageous physicochemical, chemical, and biological properties. The important biological properties of these natural polymers derived from animals are biocompatibility and biodegradation. These polymers are generally composed of repeated units of amino acids. Moreover, these polymers can be modified physically and/or chemically to improve their biomaterial properties. Natural Polymers for Pharmaceutical Applications, Volume 3: Animal-Derived Polymers looks at how these polymers can be exploited as pharmaceutical excipients in various pharmaceutical dosage forms, like microparticles, nanoparticles, ophthalmic preparations, gels, implants, etc. The commonly used animal-derived polymers used as pharmaceutical excipients are hyaluronic acid (hyaluronan), albumin, collagen, gelatin, chondroitin, etc.

This first-of-its-kind handbook offers crucial information on the safety of drugs taken during pregnancy. It covers an exhaustive list of common and less common drugs and provides for each drug the FDA letter categorization and newly approved "Pregnancy and Lactation Labeling Rule (PLLR)" systems for rating drug risks in pregnancy, imposed by the U.S. Food and Drug Administration (FDA). Drugs in Pregnancy: A Handbook for Pharmacists and Physicians covers the pregnancy ramifications of using anti-infective, cardiovascular, hematologic, dermatologic drugs and drugs affecting the endocrine, central, autonomic, gastrointestinal, musculoskeletal systems in addition to herbs, vitamins and dietary supplements. To enable the reader to develop well-informed knowledge about a drug safety profile during pregnancy, three sections of data have been provided for each drug: FDA Category, Risk Summary, and Further Reading.

"Hills is probably the best person I can think of to write this book. He has the deepest background combined with considerable experience in solving problems with food." —R. G. Bryant, University of Virginia.

Food scientists have many excellent tools at their disposal with which to study food at both the micro- and macrostructural levels. But, when it comes to analyzing dynamic structural changes in food during processing and storage, none can compare with magnetic resonance imaging (MRI). Still a very young approach, MRI food imaging has contributed greatly to recent advances in food science, and promises to yield much more valuable information in the years ahead. Written by a leading pioneer in the field, Magnetic Resonance Imaging in Food Science covers the latest in MRI food imaging theory and practice.

Written primarily for food scientists and engineers, the book offers a practical, unified approach to the subject. Material is organized in three main parts corresponding to the distances of scale probed by MRI studies—namely, the macroscopic, microscopic, and macromolecular. Throughout, the emphasis is on ways in which studies of food undergoing processes can be modeled using the equations of heat, mass, and momentum transport, and how those models can be used in process design optimization programs.

Magnetic Resonance Imaging in Food Science provides researchers with the most up-to-date, detailed coverage of:

• Traditional and cutting-edge MRI food imaging techniques and technologies, including STRAFI, gradient-echo imaging, and functional imaging
• Whole plant functional imaging, flow imaging and rheology, and other specialized MRI applications
• The roles of food microstructure and molecular relaxation mechanisms in controlling moisture and heat transport
• Techniques for modeling structural changes during food processing.

Magnetic Resonance Imaging in Food Science is an important working resource for all researchers engaged in the never-ending struggle to produce safer, higher-quality foods more efficiently.

Particularly in healthcare fields, there is growing movement away from traditional lecture style course towards active learning and team-based activities to improve learning and build higher level thinking through application of complex problems with a strong foundation of facts and data. Essential Pharmaceutics is suited to this modern teaching style, and is the first book of its kind to provide the resources and skills needed for successful implementation of an active learning pharmaceutics course.This text offers a format that is specifically suited for integration in an active learning, team-based classroom setting. It is ideal for self-learning for the beginning pharmaceutics student, based upon the extensive utilization of figures, tables, and its overview of essential topics in pharmaceutics. Also unique to this text is the integration of case studies based upon modern pharmaceutical products which are designed to reinforce importance pharmaceutical concepts and teach essential skills in literature review and patent searching. Case studies covering all topics covered in the text have been developed by the authors that allow application of the content in the flipped-classroom pharmaceutical course.

Presents cutting-edge research in biomedical engineering from materials, devices, imaging, and information perspectives All chapters are results of collaborative research in engineering and life sciences Useful resource for researchers, students, and general readers in biomedical engineering

Nanotechnology has the potential to change every part of our lives. Today, nanotechnology-based products are used in many areas, and one of the most important areas is drug delivery. Nanoparticulate drug delivery systems not only provide controlled delivery of drugs and improved drug solubility but also improve drug efficiency and reduce side effects via targeting mechanisms. However, compared with conventional drug delivery systems, few nanoparticle-based products are on the market and almost all are nontargeted or only passively targeted systems. In addition, obtaining targeted nanoparticle systems is quite complex and requires several evaluation mechanisms. This book discusses the production, characterization, regulation, and currently marketed targeted nanoparticle systems in a broad framework. It provides an overview of targeted nanoparticles' (i) in vitro characterization, such as particle size, stability, ligand density, and type; (ii) in vivo behavior for different targeting areas, such as tumor, brain, and vagina; and (iii) current advances in this field, including clinical trials and regulation processes.

Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible. The 11th CMR Workshop, held in September 1995, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss views and exchange experiences on the subject of improving the review process. The proceedings of this meeting provide a comprehensive overview of the current review process around the world. The contributors describe the present situation and highlight company strategies and regulatory initiatives to improve the review process. This volume also summarises the suggestions that were developed by the participants, covering many facets of this process, including the quality and size of the dossier, dialogue, submission strategies, feedback and the response to questions.

The book presents an innovative technology based on injection of a very weak current to trace the quantity of a drug carried immediately after the administration. The book makes the reader familiar with the technology, from the conception through the design of the instrument, up to the preliminary clinical applications. In the first chapter, the method of transdermal drug delivery and the use of impedance spectroscopy in the dermatological field are presented. The second chapter describes a screening measurement campaign aimed at proving the feasibility of the assessment method and identifying the bandwidth of interest. The prototyping, validation and characterization of an instrument to measure the amount of drug delivered (DUSM: Drug Under Skin Meter) are presented in chapter three. In the fourth chapter three experimental campaigns, based on the electrical analysis of the biological tissue behavior due to the drug delivery, are reported: (i) laboratory emulation on eggplants, (ii) ex-vivo tests on pig ears, and finally (iii) in-vivo tests on human volunteers. In the fifth chapter a behavioral model, based on Finite Elements and Partial Differential Equation, of an impedance-based measurement system for assessing the drug released under the skin, during transdermal delivering, is proposed. The last chapter is dedicated to present a campaign in order to prove the suitability for insulin therapy applications. This book is intended for biomedical engineers, biomedical engineering students, operators working in the field of biomedical instrumentation, biotechnologists, and technicians of transdermal vehiculation.

The definitive compendium of bioassay procedures and applications

A virtual encyclopedia of key bioassay protocols, this up-to-date, essential resource reviews the methods and applications of bioassays that quantify drug activity and evaluate the validity of pharmacological models.

Demonstrating the specific ways in which various pharmaceutical bioassays interpret the activity of drug molecules, the book covers the evaluation and screening of drug compounds in a wide spectrum of therapeutic categories.

Throughout, the authors use various models to link experimental observations with findings that clarify the effect of drug compounds on cellular biology and measure the pharmacological activity of chemical substances. This provides an important technological platform for successful drug research and clinical therapy, making "Pharmaceutical Bioassays" an ideal sourcebook for pharmacologists, pharmaceutical and medical researchers, analytical chemists, toxicologists, and students.

Just as a fundamental knowledge of pharmaceutical bioassays is vital to understanding how bioactive agents and new drugs are defined, discovered, and developed, so too is this indispensable reference, which:

Offers a complete reference on pharmaceutical bioassays and their specific applications in the assessment of therapies for cancer, Alzheimer's, diabetes, epilepsy, inflammation, antimalarials, pharmacogenomics, and other major therapeutic areas

Covers bioassays that measure toxicity, including those for chemical toxicity and hepatoxicity--a particularly significant consideration in the development of safe and tolerable medications

Highlights clinically relevant methods, ideas, and techniques to support any pharmaceutical researcher

Suggests guidelines and systems to enhance communication between pharmacologists, chemists, and biologists

Provides an informative analysis of pharmaceutical bioassay technologies and lab applications

Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made available, we are realizing the non-linearity of these systems. The concepts and techniques of nonlinear analysis allow for more realistic and accurate models in science. The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy who are interested in an entirely new approach to how we will treat disease in the future. Key Features: Addresses a new approach of nonlinear analysis. Applies a theory of projection to chalk out the future, instead of basing on linear evolution. Provides an opportunity to better understand the non-linearity in biological systems and its applications in various areas of science, primarily pharmaceutical sciences. Helps change the thought process for those looking for answers to their questions which they do not find in the linear relationship approach. Encourages a broader perspective for the creative process of drug development.

Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made available, we are realizing the non-linearity of these systems. The concepts and techniques of nonlinear analysis allow for more realistic and accurate models in science. The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy who are interested in an entirely new approach to how we will treat disease in the future. Key Features: Addresses a new approach of nonlinear analysis. Applies a theory of projection to chalk out the future, instead of basing on linear evolution. Provides an opportunity to better understand the non-linearity in biological systems and its applications in various areas of science, primarily pharmaceutical sciences. Helps change the thought process for those looking for answers to their questions which they do not find in the linear relationship approach. Encourages a broader perspective for the creative process of drug development.

The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a "one of a kind" contribution to the field. The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated bioanalysis of both small and large molecule therapeutics from both a scientific and regulatory viewpoint. The content will be useful to a wide spectrum of readers: from those new to bioanalysis; to those developing their experience in the laboratory, or working in one of the many critical supporting roles; to seasoned practitioners looking for a solid source of information on this exciting and important discipline.