It gives me immense pleasure to present a book entitled "Quality assurance techniques in pharmaceuticals". Need to write this book is ever increasing the data on the subject matter of quality assurance. In the era of quality assurance, every firm need to be quality assured so that it can achieve its quality goal. Book is prepared to emphasis on the basic techniques, methods, plans, certification procedures for quality assurance, keeping in mind the syllabus of quality assurance techniques laid by various Indian universities. Goal of this book is to provide primary and update knowledge of various quality assurance data to master of pharmacy students in the professional programme of their study. The on statistical methods used for method development is prepared by keeping in mind the need of method development for various drug combinations. Special emphasis is given on modern techniques like SUPAC and PAT. Beside these ISO,GMP,ICH Guidelines are very well explained.

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.

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

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

Describes the biobased natural products to combat microbial diseases. Examines the antimicrobial potential of mushrooms, endophytes and secondary metabolites. Discusses the role of defensins and terpenes in microbial diseases. Incorporates natural products from Amazon for microbial diseases.

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.

Translational medicine addresses the gap between research and the clinical application of new discoveries. To efficiently deliver new drugs to care centers, a preclinical evaluation, both in vitro and in vivo, is required to ensure that the most active and least toxic compounds are selected as well as to predict clinical outcome. Antimicrobial nanomedicines have been shown to have higher specificity in their therapeutic targets and the ability to serve as adjuvants, increasing the effectiveness of pre-existing immune compounds. The design and development of new standardized protocols for evaluating antimicrobial nanomedicines is needed for both the industry and clinical laboratory. These protocols must aim to evaluate laboratory activity and present models of pharmacokinetic-pharmacodynamic and toxicokinetic behavior that predict absorption and distribution. Likewise, these protocols must follow a theranostics approach, be able to detect promising formulations, diagnose the infectious disease, and determine the correct treatment to implement a personalized therapeutic behavior. Given the possibilities that nanotechnology offers, not updating to new screening platforms is inadequate as it prevents the correct application of discoveries, increasing the effect of the valley of death between innovations and their use. This book is structured to discuss the fundamentals taken into account for the design of robust, reproducible and automatable evaluation platforms. These vital platforms should enable the discovery of new medicines with which to face antimicrobial resistance (RAM), one of the great problems of our time.

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.

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 book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development. It discusses the applications of experimental designs that shall include oral, topical, transdermal, injectables preparations, and beyond for nanopharmaceutical product development, leading to dedicated case studies on various pharmaceutical experiments through illustrations, art-works, tables and figures. This book is a valuable guide for all academic and industrial researchers, pharmaceutical and biomedical scientists, undergraduate and postgraduate research scholars, pharmacists, biostatisticians, biotechnologists, formulations and process engineers, regulatory affairs and quality assurance personnel.

This book is a comprehensive compilation of modern and cutting-edge chromatographic techniques written by pharmaceutical industry experts, academics, and vendors in the field. This book is an inclusive guide to developing all chromatographic methods (such as liquid chromatography and gas chromatography). It covers modern techniques for developing methods using chromatographic development software, requirements for validations, discussion on orthogonality, and how to transfer methods from HPLC to UHPLC. The text introduces some newer techniques that are heavily employed by chemists analyzing proteins and RNAi, as well as novel techniques such as counter current chromatography. This book is valuable for both the novice starting out in undergraduate labs and those who are new to the pharmaceutical industry and is a useful reference for seasoned analysts.

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.

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.

Vol. 2 of Chemoinformatics of Natural Products introduces the reader to the currently available tools for toxicity prediction, drug property prediction, an enumeration of compounds, scaffolds and functional groups in nature, computational methods for lead identification, metabolite biosynthesis, etc. Selected case studies and hands-on tutorial exercises have been included.

This Fourth Edition has been thoroughly revised and updated to take account of international developments in pharaceutical chemistry and to maintain the position of Practical Pharmaceutical Chemistry as the leading University textbook in the field of pharaceutical analysis and quality control. Part 2 deals with physical techniques of analysis for more advanced courses. It gives a broad coverage of the most widely used techniques in quantative chromatography. The treatmentof spectroscopy and radiopharmaceuticals has also been increased. Thre are additional chapters on the contribution and role of physical methods of analysis in the various stages of drug development; and a series of workshop-style exercises, illustrating the application of spectroscopic techniques in structural elucidation and verification of identity. Users of the two volumes will welcome the internationalisation of the text, with examples based on drugs and dosage forms that are widespread and in commun use in human medicine in Britain, continental Europe and North America. Additionally there is some reference to veterinary pharmaceuticals where they provide appropriate examples.

This book covers nanotechnology based approaches for improving the therapeutic efficacy of natural products. It critically explores lipid nanoarchitectonics, inorganic particles and nanoemulsion based tools for delivering them. With its chapters from eminent experts working in this discipline, it is ideal for researchers and professionals working in the area.

This book covers recent advances of the fragment molecular orbital (FMO) method, consisting of 5 parts and a total of 30 chapters written by FMO experts. The FMO method is a promising way to calculate large-scale molecular systems such as proteins in a quantum mechanical framework. The highly efficient parallelism deserves being considered the principal advantage of FMO calculations. Additionally, the FMO method can be employed as an analysis tool by using the inter-fragment (pairwise) interaction energies, among others, and this feature has been utilized well in biophysical and pharmaceutical chemistry. In recent years, the methodological developments of FMO have been remarkable, and both reliability and applicability have been enhanced, in particular, for non-bio problems. The current trend of the parallel computing facility is of the many-core type, and adaptation to modern computer environments has been explored as well. In this book, a historical review of FMO and comparison to other methods are provided in Part I (two chapters) and major FMO programs (GAMESS-US, ABINIT-MP, PAICS and OpenFMO) are described in Part II (four chapters). dedicated to pharmaceutical activities (twelve chapters). A variety of new applications with methodological breakthroughs are introduced in Part IV (six chapters). Finally, computer and information science-oriented topics including massively parallel computation and machine learning are addressed in Part V (six chapters). Many color figures and illustrations are included. Readers can refer to this book in its entirety as a practical textbook of the FMO method or read only the chapters of greatest interest to them.

This book contains most updated information on synthesis of magnetic nanohybrids, their physio-chemical properties, and key biological applications. It highlights the complexity of nanoheterostructures, especially magnetic metal oxides, ferrites and doped magnetic nanomaterials, and discusses their potential applications in the early detection, imaging and treatment of cancer. It also covers the toxicity and risk assessment of multifunctional nanomaterials. Providing an overview of magnetic nanoheterostructures, it appeals to a wide audience, from beginners and graduate-level students to experts in academia and industry.

This book includes an international group of researchers who present the latest achievements in the field of enzyme, immune system, and microbial and nano-biosensors. It highlights the experimental evidence for formation of biological fuel cells (BFCs)-which has a dual purpose - as a device that produces electricity and the systems which produce it simultaneously cleaning up the environment from polluting organic compounds. Considering the work in the field of macro, micro and nano-biosensors, considerable attention is paid to the use of nanomaterials for the modification of working electrodes. Nanomaterials in some cases can significantly improve the parameters of analytical systems. Readers will be interested in the projection of the presented theoretical and experimental materials in the field of practical application of modern analytical developments. The presented results in many cases imply the possibility of using the created models of macro, micro and nano-biosensors, and biofuel elements in the field of health, and protection/restoration of the environment. It includes information about all existing types of transducers of signals in biosensors - electrochemical, optical and quantum-optics, thermoelectric, data of atomic force microscopy, piezoelectric, and more. On the basis of these principles, descriptions are given about the functioning of macro, micro and nano- biosensors for the detection of compounds used in medicine, detection of compounds that clog the environment, and thus affect human health, for compounds that are potentially the basis for the production of drugs, for the selection of compounds that have medicinal activity, for immunodetection, and to assess the quality of food. These questions form the basis of research carried out in the field of biosensors in the world. Since the described models of biosensors have high sensitivity, high measurement speed and selectivity, the described results attract the attention of both the ordinary reader and business class specialists who create and implement analytical technologies. This book is very useful for researchers in life sciences, chemical sciences, physics, and engineering. In addition, it will be useful for the persons working in industry. Advanced technologies specialists will be attracted by the novelty of the proposed solutions and their relevance and ease of implementation. Since the studies contain sections describing the parameters of different biosensors, BFCs, they are easily navigated into assessing the effectiveness of the practical use of the proposed device. The relevant sections indicate such characteristics as detection ranges, life span, type of biological material used, the method of formation of the bio-receptor part. These parameters are of interest to both developers of new models of biosensors and BFC, and their manufacturers.

Inorganic Controlled Release Technology: Materials and Concepts for Advanced Drug Formulation provides a practical guide to the use and applications of inorganic controlled release technology (iCRT) for drug delivery and other healthcare applications, focusing on newly developed inorganic materials such as bioresorbable glasses and bioceramics. The use of these materials is introduced for a wide range of applications that cover inorganic drug delivery systems for new drug development and the reformulation of existing drugs. The book describes basic concepts, principles, and industrial practices by discussing materials chemistry, physics, nano/microstructure, formulation, materials processing, and case studies, as well as the evaluation and characterization of iCRT systems commonly investigated during industrial R&D.

Written by a pioneer in the development of spin labeling in biophysics, this expert book covers the fundamentals of nitroxide spin labeling through cutting-edge applications in chemistry, physics, materials science, molecular biology, and biomedicine. Nitroxides have earned their place as one of the most popular organic paramagnets due to their suitability as inhibitors of oxidative processes, as a means to polarize magnetic nuclei, and, in molecular biology, as probes and labels to understand molecular structures and dynamics AS DRAGS FOR CANCER AND OTHER DISEASES. Beginning with an overview of the basic methodology and nitroxides' 145-year history, this book equips students with necessary background and techniques to undertake original research and industry work in this growing field.

Statistical Issues in Drug Development The revised third edition of Statistical Issues in Drug Development delivers an insightful treatment of the intersection between statistics and the life sciences. The book offers readers new discussions of crucial topics, including cluster randomization, historical controls, responder analysis, studies in children, post-hoc tests, estimands, publication bias, the replication crisis, and many more. This work presents the major statistical issues in drug development in a way that is accessible and comprehensible to life scientists working in the field, and takes pains not to gloss over significant disagreements in the field of statistics, while encouraging communication between the statistical and life sciences disciplines. In addition to new material on topics like invalid inversion, severity, random effects in network meta-analysis, and explained variation, readers will benefit from the inclusion of: A thorough introduction to basic topics in drug development and statistics, including the role played by statistics in drug development An exploration of the four views of statistics in drug development, including the historical, methodological, technical, and professional An examination of debatable and controversial topics in drug development, including the allocation of treatments to patients in clinical trials, baselines and covariate information, and the measurement of treatment effects Perfect for life scientists and other professionals working in the field of drug development, Statistical Issues in Drug Development is the ideal resource for anyone seeking a one-stop reference to enhance their understanding of the use of statistics during drug development.

Pharmaceutical research draws on increasingly complex techniques to solve the challenges of drug design. Bringing together a number of the latest informatics techniques, this book looks at modelling and bioinformatic strategies; structural genomics and X-ray crystallography; virtual screening; lead optimisation; ADME profiling and vaccine design. A number of relevant case studies, focussing on techniques that have demonstrated their use, will concentrate on G-protein coupled receptors as potential disease targets. Providing details of state-of-the-art research, Drug Design: Cutting Edge Approaches will be invaluable to all drug discovery scientists, including medicinal and combinatorial chemists, molecular modellers, bio- and chemoinformaticians, and pharmacologists, amongst others. University and pharmaceutical company libraries will also benefit from having a copy on their shelves.

Reflecting the fascinating and dramatic changes in pharmacy, pharmaceutical education, and the pharmaceutical industry in recent years, this authoritative volume focuses on the practice of marketing both prescription and nonprescription medications. In a dozen comprehensive chapters, author Mickey Smith highlights the economic social, and legal aspects of marketing pharmaceutical products, examines the consumers and prescribers, and explores successful marketing, pricing, and distributions strategies. The text explains in detail how marketing is conducted, gives examples of successful marketing, and presents "real world" cases to illustrate the technical points.Written from the industry perspective, Pharmaceutical Marketing enables those involved in marketing on a daily basis to greater understand the functions of pharmaceutical marketing and consequently, plan more carefully and accurately, their marketing strategies. Those entering the field of marketing pharmaceutical products--sales people, assistant product managers, marketing staff--and government policymakers in the drug field, will gain a greater understanding of the industry. You will benefit from the information on the marketing mix--product, promotion, distribution, and pricing; marketing environments; corporate and competitive analysis; and market and marketing research as presented in this unique book.An invaluable reference for anyone involved in pharmaceutical marketing, this excellent book will be of great benefit not only to market researchers but also to chain-store executives, wholesale executives, and detail men, especially those new to these positions. In addition the book will serve as a good text for graduate and undergraduate students in pharmaceutical marketing programs. Although consciously directed at those who would or do practice pharmaceutical marketing,this highly readable book will also provide an understanding of the functions of pharmaceutic

An introductory but detailed treatise which includes some 1,000 references and solved examples and end-of-chapter problems, making it useful to both students and practitioners. The pharmokinetics, pharmacodynamics, and biological and biopharmaceutical parameters pertinent to each route of administra