This book reviews the current state of ocular drug therapy and future therapeutic opportunities for a wide variety of conditions, including Age-related Macular Degeneration, Diabetic Retinopathy and Macular Edema, Glaucoma, and Inherited Retinal Diseases. Retinal diseases are major contributors to moderate or severe vision impairment in adults aged 50 years and older. The respective patient populations for many of these indications is expected to significantly increase as the world population continues to grow older. An improved understanding of the etiological underpinnings of ocular degenerative diseases over the past decade has significantly bolstered ophthalmic drug discovery. In this volume, contributions from leading experts explore the unique challenges faced for ocular drug discovery and delivery providing the reader with detailed information on ocular pharmacokinetics, in vitro, ex vivo and in vivo models for retinal disease pathology and emerging gene therapy treatments. The book is intended for all researchers and clinicians who wish to increase their knowledge on the latest findings in ocular drug therapy.

This contributed volume presents an overview of concepts, methods, and applications used in several quantitative areas of drug research, development, and marketing. Chapters bring together the theories and applications of various disciplines, allowing readers to learn more about quantitative fields, and to better recognize the differences between them. Because it provides a thorough overview, this will serve as a self-contained resource for readers interested in the pharmaceutical industry, and the quantitative methods that serve as its foundation. Specific disciplines covered include: Biostatistics Pharmacometrics Genomics Bioinformatics Pharmacoepidemiology Commercial analytics Operational analytics Quantitative Methods in Pharmaceutical Research and Development is ideal for undergraduate students interested in learning about real-world applications of quantitative methods, and the potential career options open to them. It will also be of interest to experts working in these areas.

Addressing concerns for patient welfare while protecting producer reputation, and providing a database for formulation of other products, this multiauthored reference blends fundamental theory and practical advice on drug product stability in scientific, technical, and regulatory environments, covering development of indicating assays, computer use, clinical trial materials, strategic planning, and packaging. Describing the documentation required to minimize the changes of regulatory citations, the book lists manufacturers of photostability testing chambers, stability system software, and laboratory information management systems for pharmaceutical applications.

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 chemists; cell and molecular biologists; biochemists; and upper-level undergraduate and graduate students in these disciplines.

Suppliers of pharmaceutical manufacturing equipment must ensure that their equipment is provided to their customers in a validatable state. Written in simple, clear, and concise language that gets past all the regulationese, this book covers the basics of validation, planning process equipment design and construction, documentation requirements, avoiding validation pitfalls, and the types of services the supplier should provide. The book provides insights on how to avoid the costly and time-consuming problem of reworking the equipment to develop the information that is needed to successfully complete their validation package - after the equipment has been delivered and installed. Here in one volume is all the information suppliers and manufacturers need to be able to effectively conduct business in a cost- and time-effective manner. Key areas of discussion include: o Validation and GMP issues o Why validation is so important to pharmaceutical manufacturers o The role of equipment suppliers in supporting validation o How validation affects the quality of drugs o A discussion of the importance of each phase of validation o Examples of pre-validation work o Pharmaceutical industry conventions for equipment design & construction o Questions to ask about validation, including a checklist o Regulations in plain language, including the terms and vocabulary o Computer validation o Business & cost issues

A reference on drug metabolism and metabolite safety in the development phase, this book reviews the analytical techniques and experimental designs critical for metabolite studies. It features case studies of lessons learned and real world examples, along with regulatory perspectives from the US FDA and EMA. Reviews the analytical techniques and experimental designs critical for metabolite studies Covers methods including chirality, species differences, mass spectrometry, radiolabels, and in vitro / in vivo correlation Discusses target pharmacology, in vitro systems aligned to toxicity tests, and drug-drug interactions Includes perspectives from authors with firsthand involvement in industry and the study of drug metabolites, including viewpoints that have influenced regulatory guidelines

Thanks to their unique properties, chitosan and chitosan-based materials have numerous applications in the field of biomedicine, especially in drug delivery. This book examines biomedical applications of functional chitosan, exploring the various functions and applications in the development of chitosan-based biomaterials. It also describes the chemical structure of chitosan and discusses the relationship between their structure and functions, providing a theoretical basis for the design of biomaterials. Lastly, it reviews chemically modified and composite materials of chitin and chitosan derivatives for biomedical applications, such as tissue engineering, nanomedicine, drug delivery, and gene delivery.

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide "one stop shopping" for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.

This book explores efficient syntheses of indole alkaloids based on gold-catalyzed cascade cyclizations, presenting two strategies for total synthesis of these natural products based on gold-catalyzed reactions of conjugated diyne or ynamide. The book first describes the total and formal synthesis of dictyodendrins A-F based on direct construction of the pyrrolo[2,3-c]carbazole core using the gold-catalyzed annulation of azido-diynes and protected pyrrole. This synthetic strategy features late-stage functionalization of the pyrrolo[2,3-c]carbazole scaffold at several positions and allows diverse access to dictyodendrins and their derivatives. Secondly, the book discusses the formal synthesis of vindorosine based on the pyrrolo[2,3-d]carbazole construction using the gold-catalyzed cascade cyclization of ynamide. Importantly, the reaction using a chiral gold complex provides the optically active pyrrolo[2,3-d]carbazole. This strategy facilitates the rapid construction of the pyrrolocarbazole core structure of aspidosperma and related alkaloids, including vindorosine. These methodologies can accelerate the medicinal application of pyrrolocarbazole-type alkaloids and related compounds.

This useful reference describes the statistical planning and design of pharmaceutical experiments, covering all stages in the development process-including preformulation, formulation, process study and optimization, scale-up, and robust process and formulation development.Shows how to overcome pharmaceutical, technological, and economic constraints on experiment design!Directly comparing the advantages and disadvantages of specific techniques, Pharmaceutical Experimental DesignA* offers broad, detailed, up-to-date descriptions of designs and methods not easily accessible in other booksA* reviews screening designs for qualitative factors at different levelsA* presents designs for predictive models and their use in optimizationA* highlights optimization methods, such as steepest ascent, optimum path, canonical analysis, graphical analysis, and desirabilityA* discusses the Taguchi method for quality assurance and approaches for robust scaling up and process transferA* details nonstandard designs and mixturesA* analyzes factorial, D-optimal design, and offline quality assurance techniquesA* reveals how one experimental design evolves from anotherA* and more!Featuring over 700 references, tables, equations, and drawings, Pharmaceutical Experimental Design is suitable for industrial, research, and clinical pharmaceutical scientists, pharmacists, and pharmacologists; statisticians and biostatisticians; drug regulatory affairs personnel; biotechnologists; formulation, analytical, and synthetic chemists and engineers, quality assurance personnel; all users of statistical experimental design in research and development; and postgraduate and postdoctoral research workers in these disciplines.

Pharmacology in Drug Discovery and Development: Understanding Drug Response, Second Edition, is an introductory resource illustrating how pharmacology can be used to furnish the tools necessary to analyze different drug behavior and trace this behavior to its root cause or molecular mechanism of action. The concepts discussed in this book allow for the application of more predictive pharmacological procedures aimed at increasing therapeutic efficacy that will lead to more successful drug development. Chapters logically build upon one another to show how to characterize the pharmacology of any given molecule and allow for more informed predictions of drug effects in all biological systems. New chapters are dedicated to the interdisciplinary drug discovery environment in both industry and academia, and special techniques involved in new drug screening and lead optimization. This edition has been fully revised to address the latest advances and research related to real time kinetic assays, pluridimensional efficacy, signaling bias, irreversible and chemical antagonism, allosterically-induced bias, pharmacokinetics and safety, target and pathway validation, and much more. With numerous valuable chapter summaries, detailed references, practical examples and case studies throughout, Dr. Kenakin successfully navigates a highly complex subject, making it accessible for students, professors, and new researchers working in pharmacology and drug discovery.

Nanophytomedicine is a field that involves the application of nanomedicine-based systems to phytotherapy and phytopharmacology. This book assesses the clinical successes and failures of nanophytomedicine and also highlights emerging concepts in this field. The content is divided into three sections, the first of which describes core issues in the pharmaceuticals industry in connection with the successes, failures and prospects of nanophytomedicine. The second section highlights recent advances in phytomedicine formulation development based on nanotechnology approaches, while also discussing a variety of nanocarrier systems for the successful delivery of phytomedicines. Focusing on the clinical perspective, the third section addresses the current clinical status of nanophytomedicine as a single drug therapy or combinatorial drug therapy, pharmacovigilance, pharmacokinetics, drug interactions and toxicological profiles, while also providing concluding remarks on recent experimental findings, and considering ethical issues & regulatory challenges in nanophytomedicine. Given its scope, the book offers a valuable guide for early career researchers, young scientists, master level students, academics and industrial scientists working in various healthcare fields, e.g. the pharmaceutical and biological sciences, life sciences, biotechnology, biomedical engineering, and nanobiotechnology.

Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors' substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book:

The book presents a comprehensive and up-to-date overview of phytochemicals as efficient cancer therapeutics. Over the last few decades there has been a paradigm shift from conventional cancer therapeutic approaches to alternative and complementary medicinal approaches especially using phytoconstituents from natural products. As such, the book provides an in-depth understanding of phytochemicals targeting diverse signaling pathways involved in cancer along with the evaluation of the cancer modulatory effects of phytochemicals. It also highlights the potential modulatory effect of single nucleotide polymorphisms (SNPs) on the cancer-associated cellular pathways and their interactions with the phytochemicals. Further, it analyzes the drug delivery methods, bioavailability of active components of botanicals, and toxicity of phytochemicals. Lastly, the book elucidates the 3D cell culture and animal models systems to analyze the beneficial effects of phytochemicals in cancer.

This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process.
Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms
details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process
describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization
considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance
elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity
shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends
reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications
and more
Furnished with helpful references, tables, and drawings, this practical guide is indispensable for pharmaceutical, medicinal, and protein chemists; molecular biologists; process engineers; purification scientists; biopharmaceutical and pharmaceutical formulators and product developers; quality control, quality assurance, and regulatory compliance personnel; and upper-level undergraduate and graduate students in these disciplines.

This incomparable Second Edition of a highly regarded reference has been entirely rewritten and enlarged to reflect the explosion of information and technologies that have emerged since the publication of the previous edition.
Strikes the perfect balance between proven traditional approaches and modern methods that promise to yield new products and processes
Specifically addressing microbially derived commercially important bioactive products that are currently or soon-to-be available, Biotechnology of Antibiotics, Second Edition
analyzes the use of recombinant enzymes to produce biologically active molecules, including a cholesterol-lowering agent, an anti-HIV drug for the treatment of AIDS, and b-lactam antibiotics
gives insight into the biochemistry, molecular biology, and production of antibiotics used as therapeutic agents
focuses on state-of-the-art techniques for the development of new antibiotics using novel approaches and strategies
highlights recent advances in the genetic manipulation of antibiotic biosynthesis genes to create structures from gene combinations for new biological activities
describes in detail the development and current status of newly created antibiotics and pharmacologically active natural products
and much more
Written by authorities from both industry and academia and containing nearly 4000 bibliographic citations, Biotechnology of Antibiotics, Second Edition is an outstanding resource for pharmaceutical scientists, medicinal chemists and biochemists, molecular biologists and industrial microbiologists, chemical engineers, fermentation bioengineers, bioprocess technologists, and upper-level undergraduate and graduate students in these disciplines.

Continuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research groups from different academic institutions have significantly contributed to this field with an immense amount of published research addressing a variety of topics related to continuous processing. The book is structured to have individual chapters on the different continuous unit operations involved in drug substance and drug product manufacturing. A wide spectrum of topics are covered, including basic principles of continuous manufacturing, applications of continuous flow chemistry in drug synthesis, continuous crystallization, continuous drying, feeders and blenders, roll compaction and continuous wet granulation.The underlying theme for each of these chapters is to present to the reader the recent advances in modeling, experimental investigations and equipment design as they pertain to each individual unit operation. The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality/GMP aspects, as well as regulatory gaps and challenges. Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. In addition, our advanced readers and practitioners in this field will find that the technical content of Continuous Pharmaceutical Processing is at the forefront of recent technological advances, with coverage of future prospects and challenges for this technology.

Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.

This practical book provides detailed guidance on all aspects of clean room airflow, the mechanics of airflow, and how microbial contamination is carried. Ljungqvist and Reinmuller draw on years of experience in clean room design and operation. The book contains maps of the effect of human interference on unidirectional airflow and the potential for contamination. Particle challenge test methods and tracer gas detection methods are explained, and the impact and interpretation of the results obtained from these test methods are discussed. Topics include: o Dispersion of Airborne Contaminants o Contamination Risks o Wakes (including factual situations) o Open, Unidirectional Air Flow Benches (laminar flow benches) o Microbiological Assessment o Weighing Stations o Air Flow Through Openings o Mathematical Treatment of Contamination Risks o Simulation of Air Flows & Dispersion of Contaminants through Doorways in a Suite of Clean Rooms o Regulatory Requirements

This text lists the necessary steps for meeting compliance requirements during the drug development process. It presents comprehensive approaches for validating analytical methods for pharmaceutical applications.

This book summarizes experimentally-supported research on the therapeutic efficacy of plant extracts and their constituents on a range of respiratory diseases including infections. It discusses the pharmacological, cellular and molecular factors involved in the pathogenies of respiratory diseases and their modulation by plant-derived compounds. Additionally, it underlines the growing relevance of medicinal plant-based advanced drug delivery systems for treating lung diseases providing maximal therapeutic efficacy with better patient compliance. Overall, this comprehensive book is a blend of translational, biological, chemical and drug delivery aspects of medicinal plants employed in targeting respiratory diseases and attracts a range of audiences including physiochemist, translational and clinical researchers working in the field of respiratory diseases.

Social and Behavioral Aspects of Pharmaceutical Care takes known social and behavioral science principles and applies them to pharmacy practice. This allows readers who are training to deliver or already delivering pharmaceutical care to enhance their communication, counseling, and patient education skills. While working through this superb text, students and practitioners will develop optimal skills as problemsolvers, therapeutic consultants, patient educators, and counselors as they learn how to enhance patient compliance, negate stigma, and help patients become more comfortable with their medical situations. The instructor's manual that comes with the text is filled with exercises that highlight the most important aspects of each chapter and engages readers in the content of each chapter. Readers who approach this text with a real desire to better understand how behavior links to the complexities of an individual's or social group's actions and deeds will find it exhilarating reading as they gain a better understanding of and appreciation for pharmaceutical care and its behavioral underpinnings.Also, instead of offering only a few definitive answers, Social and Behavioral Aspects of Pharmaceutical Care contains extensive descriptions of phenomena known to be true but which are all subject to change when new variables are introduced. This helps readers become more aware of and comfortable with the gray areas of pharmacy. Authors in Social and Behavioral Aspects of Pharmaceutical Care take pieces of the complex web of pharmaceutical care, describe known microcosmic components of such care, and then relate the pieces back to the integrity of the web. Readers will find that the behavior of the patient, the prescriber, the systems that allow for these interactions, and, ultimately, the outcomes of medication use are in fact, not as simple as they may appear.Readers learn to deal with these complexities by improving their interactive skills in these areas: compliance placebosmedication stigma self-medicationhealth beliefs opinion informationprofessionalism socializationnonmedical drug use public healthillness behavior sick rolehow attitudes affect behaviorsethics Using this text in pharmaceutical administration, social pharmacy, and behavioral pharmacy courses better prepares training pharmacists for contemporary and future roles that more closely bind them to their patients and their prescribing community. It offers an excellent, comprehensive overview of the social-economic aspect of pharmaceutical care through its theoretical models and practical examples that elaborate on the pharmacist's role in identifying patients'non-compliant behavior and in managing other drug-related problems.Undergraduate and graduate pharmacy students; pharmacy school, drug company, and health science center libraries; practicing retail and hospital pharmacists; and national, state, and local pharmacy associations will find Social and Behavioral Aspects of Pharmaceutical Care an important addition to their reading material as it serves as a valuable developmental tool for both students and practicing professionals

This book examines death rituals and the social significance of undertaking in western society and presents an ethnographic account of funeral directing in an area of east London which, for the purposes of anonymity. It is concerned with undertakers' perceptions and organization of death rituals.

Genetically Engineered Plants as a Source of Vaccines Against Wide Spread Diseases: An Integrated View provides an integrated outlook of the disciplines involved in the development of plant-based vaccines as well as an updated compilation of the successful developments in the field. The volume covers immunological aspects of mucosal vaccine design, molecular approaches to attain high levels of the recombinant antigens, the rationale of using bioreactor to expand plant biomass, and pharmaceutical technology approaches that have been applied to the development of plant-based vaccine formulations. Practical figures and tables are presented to facilitate reading and identification of key points. Perspectives for this field are also discussed. Written by authorities in the field, Genetically Engineered Plants as a Source of Vaccines Against Wide Spread Diseases: An Integrated View is a comprehensive resource for researchers and students interested in plant genetics and breeding, immunology, and genetic engineering.

A range of factors must be considered when developing a topical antimicrobial for use in a healthcare personnel handwash, surgical scrub, or preoperative skin preparation. Antimicrobial effectiveness, low skin irritation, ease of use, and pleasing aesthetics are all essential if the product is to succeed. In addition, all facets of the product must comply with stringent regulatory requirements. With updated protocols and research, Topical Antimicrobials Testing and Evaluation, Second Edition comprehensively presents and reviews the latest techniques for testing antimicrobial compounds for effectiveness and regulatory compliance. Topics include: The anatomical structure of the skin and skin microbiology relevant to product testing Use of antimicrobial products against specific microorganisms such as Staphylococcus and Streptococcus species Measurement of antimicrobial action of topical antimicrobials from experimental design, microbiological, biostatistical, and marketplace perspectives Various aspects of the topical antimicrobial products currently in common use in medical, food service, and consumer markets Statistical analysis and specific statistical designs for clinical trials Epistemological requirements in evaluating the effects of specific treatments Evaluation strategies and sample working protocols for hand and body soaps, food-handler antimicrobial products, and medical/healthcare industry antimicrobial products The book is designed to inform industry and academia on the requirements to get products approved by the FDA and to market while also providing critical insight on ways to best service expanding markets.