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Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
Phytomedicine has become more important and gained constant improvement today for the betterment of health. Herbal medicine plays a significant role in the development of new drugs, contrary to the modern medicinal systems. For more than a decade, there has been a drastic improvement in phytomedicine across the world. This growth has reached a higher level in development by pharmaceutical industries everywhere. People have drifted toward herbal medication and practices for their food and health care. Therefore, in order to create abundant interest in the research of phytosciences, this book is one of the better reference tools. The bioactive compounds in plants need to be explored to know the scientific value and therapeutic properties of the medicinal plants against many diseases. This book contains chapters that are relevant to the advanced research in herbal medicines and will enlighten readers to the importance of medicinal plants as daily sources of nutrition and cures for diseases. This book highlights the unique features of the plants that have not been studied so far for their therapeutic potential. To prove the efficacy of medicinal plants, they have to be studied, examined, and scientifically verified. Hence, this book will better serve the researchers working under different aspects of phytomedicine. Features * The information provided through scientific validation is useful to study the pharmacological activity of herbals and their administration in the modern era. * The readers can find clear understanding in the research and development of phytopharmaceutical drugs. * The ideas incorporated in each chapter reveal the knowledge gained in studying the biological activities of the compounds present in the plant, which are indeed most worthy for the development of drugs. * The harvesting of new ideology toward modern scientific technologies that are employed in the field of pharmacological research.
Designed to enable readers to plan and execute their own audits, this comprehensive guide presents both discussions and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section III illustrates with examples the document requirements of the Quality Assurance Unit and provides a clear understanding of its function. Section IV comprises the full texts of the relevant standards and regulations along with the Principles of Good Laboratory Practice.
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and analysis of stability studies. After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies. To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.
State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book's three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.
Since 1945, "The Annual Deming Conference on Applied Statistics" has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry. Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of Phase II dose-ranging trials, thorough QT/QTc clinical trials, and assay sensitivity and the constancy assumption in noninferiority trials. The second section examines adaptive designs in drug development, discusses the consequences of group-sequential and adaptive designs, and illustrates group sequential design in R. The third section focuses on oncology clinical trials, covering competing risks, escalation with overdose control (EWOC) dose finding, and interval-censored time-to-event data. In the fourth section, the book describes multiple test problems with applications to adaptive designs, graphical approaches to multiple testing, the estimation of simultaneous confidence intervals for multiple comparisons, and weighted parametric multiple testing methods. The final section discusses the statistical analysis of biomarkers from omics technologies, biomarker strategies applicable to clinical development, and the statistical evaluation of surrogate endpoints. This book clarifies important issues when designing and analyzing clinical trials, including several misunderstood and unresolved challenges. It will help readers choose the right method for their biostatistical application. Each chapter is self-contained with references.
Improve your patient's health through a fresh view of their behaviors Patients who use over-the-counter (OTC) and prescription medicine often do not take the drugs as intended, sometimes to the detriment to their health and well-being. These widespread problems cause health professionals to agonize over how to try to make sure patients comply with medication instructions. Patient Compliance with Medication: Issues and Opportunities tackles this tough issue by exploring in detail the range of noncompliance behavior, the negative impacts the behavior has on patients as well as society at large, and practical ways to influence people to take their medicine for optimum health. Respected pharmacist and author Jack Fincham and other noted experts provide insights, surprising data, and effective solutions to a challenge nearly all health professionals encounter. Patients often use drugs they get from a multitude of sources, making the capability of monitoring drug use difficult. Other problems can also interfere with a patient's health, such as a patient borrowing drugs from family or friendsor even not taking them at all simply because he or she are unable to pay for them. Patient Compliance with Medication: Issues and Opportunities goes beyond the standard pat explanations and mostly ineffective quick solutions usually offered for the complicated noncompliance issue. Leading authorities describe the range of reasons for a patient's behavior and provide practical strategies that strike at the root of the problem. Helpful tables, figures, and extensive references are also included. Topics in Patient Compliance with Medication: Issues and Opportunities include: the prevalence of noncompliance costs of noncompliance drug therapies that lead to noncompliance measuring compliance models to evaluate patient compliance evaluation methods ethical considerations health professionals' roles in compliance disease state management future considerations much more Patient Compliance with Medication: Issues and Opportunities is insightful, crucial information for health professionals, educators, and students.
Liposome Technology, Volume I: Liposome Preparation and Related Techniques, Third Edition, is a thoroughly updated and expanded new edition of a classic text in the field. Including step-by-step technical details, Volume I illustrates numerous methods for liposome preparation and auxiliary techniques necessary for the stabilization and characterization of liposomes. This source also offers critical discussions of the methodologies of each technology described so that readers can examine the benefits and limitations and compare it to other approaches.
In the fast-developing field of nanomedicine, a broad variety of materials have been used for the development of advanced delivery systems for drugs, genes, and diagnostic agents. With the recent breakthroughs in the field, we are witnessing a new age of disease management, which is governed by precise regulation of dosage and delivery. This book presents the advances in the use of metal-based and other nanomaterials for medical imaging, diagnosis, theranostics, and drug delivery. It discusses silver, hybrid gold, and surface-modified magnetic nanoparticles, fluorescent quantum dots, lipid bubbles, and nanobubbles. It provides all available information about these materials and describes in detail their advantages and disadvantages and the areas where they could be utilized successfully. The text also covers topics such as improving bioactivity of poorly soluble actives, cellular and molecular toxicology of nanoparticles, and biofate of nanoemulsions.
1) Discusses the affordability of future therapy and the possible challenges for health insurance systems 2) Highlights the gradual move from repeated treatment administration to one single administration with potential for a definite cure 3) Describes the potential change of paradigm which will challenge all payers and may question the sustainability of our health care systems
Healing Plants of Nigeria: Ethnomedicine and Therapeutic Applications offers comprehensive information on the use of herbal medicines in West Africa. Combining an evidence-based, ethnobotanical perspective with a pharmacological and pharmaceutical approach to phytomedicine, the book bridges the gap between the study of herbal plants' pharmacological properties and active compounds for the development of clinical drugs and community-oriented approaches, emphasising local use. It demonstrates how the framework of African traditional medicine can be preserved in a contemporary clinical context. The book outlines the history and beliefs surrounding the traditional use of herbs by the local population alongside their application in contemporary phytotherapy in Nigeria and West Africa. It features a critical assessment of the scientific rationale behind the use of these plants in ethnomedicine and offers a composite catalogue of phytotherapeutic and wellness agents, detailing the safety profile, efficacy, and scientific integrity of plants used to treat diseases and optimise health. Features: An ethnobotanical survey containing over 200 full-colour photographs of Nigerian and West African plants. A unique combination of ethnobotany and pharmacognosy, bridging the divide between pharmaceutical and community-oriented approaches to herbal medicine research. Contextual discussion of the therapeutic potential of Nigerian herbal medicine. Offers a template which can be used to separate the superstitious aspects of ethnomedicine from culturally inherited deposits of knowledge. A handbook for herbal and natural medicine practitioners, the book is aimed at African thinkers, scientists, healthcare providers and students of pharmacology and ethnomedicine.
This set of six volumes provides a systematic and standardized description of 23,033 chemical components isolated from 6,734 medicinal plants, collected from 5,507 books/articles published in Chinese and international journals. A chemical structure with stereo-chemistry bonds is provided for each chemical component, in addition to conventional information, such as Chinese and English names, physical and chemical properties. It includes a name list of medicinal plants from which the chemical component was isolated. Furthermore, abundant pharmacological data for nearly 8,000 chemical components are presented, including experimental method, experimental animal, cell type, quantitative data, as well as control compound data. The seven indexes allow for complete cross-indexing. Regardless whether one searches for the molecular formula of a compound, the pharmacological activity of a compound, or the English name of a plant, the information in the book can be retrieved in multiple ways.
Bioactive natural products are a rich source of novel therapeutics. Thus, the search for bioactive molecules from nature continues to play an important role in fashioning new medicinal agents. This volume, which comprises sixteen chapters written by active researchers and leading experts in natural products chemistry, brings together an overview of current discoveries in this remarkable field. It also provides information on the industrial application of natural products for medicinal purposes. This book will serve as a valuable resource for researchers to predict promising leads for developing pharmaceuticals to treat various ailments and disease manifestations.
The proliferation of herbal remedies worldwide has most dangerously outpaced quality information on their safe use. This book fills a tremendous void by offering authoritative information on the actions of herbal remedies and the results of their interactions with standard medications. It offers specific, authoritative information with a conceptual approach that focuses not only on the specific interactions, but also on the mechanisms behind those interactions and their clinical significance. With contributions from leading experts on herb-drug interactions, the text examines the overall use of herbs, includes sections on individual herbs, and considers regulatory issues and concerns.
Selecting illustrative examples from the recent literature, this reference studies the underlying principles and physics of a wide range of spectroscopic techniques utilized in the pharmaceutical sciences and demonstrates various applications for each method analyzed in the text-showing how knowledge of the mechanisms of spectroscopic phenomena may facilitate more advanced technologies in the field.
Divided into three expansive sections on biotechnological advances, applications, and research prospects, this reference provides expert summaries of the state-of-the-science in personal care product development-clearly depicting the latest breakthroughs and practices in biotechnology for the formulation and increased safety of new personal care ingredients.
The need to screen targets faster and more efficiently, coupled with advances in parallel and multiplex chemical synthesis, has contributed to the increasing use of multiwell assays for drug discovery. The Handbook of Assay Development in Drug Discovery is a reference that describes the complete armament of tools currently available for performing various assay techniques. Featuring contributions from assay developers in the pharmaceutical and vendor communities, the book presents descriptions of methods, laboratory guidelines and protocols used to perform such methods, specific examples of each assay system, and troubleshooting tools. The handbook describes biochemical assay classes as well as non-class specific assay development for cell-based assays. It covers a wide range of target classes-including kinases, proteases, nuclear receptors, and GPCRs-and describes currently employed methods and assay types, such as radioligand binding assays, image analysis assays, enzyme fragment complementation, and bioluminescent and fluorescent-based assays. Designed as a guide to running an assay from start to finish, the Handbook of Assay Development in Drug Discovery is an ideal bench top companion for discovery researchers, laboratory managers, academics, and other scientists involved in drug discovery screening, lead profiling, therapeutic target evaluation, and assay development and implementation in the pharmaceutical and biotechnology industries. Daniel E. Levy, editor of the Drug Discovery Series, is the founder of DEL BioPharma, a consulting service for drug discovery programs. He also maintains a blog that explores organic chemistry.
Melville's Monumental Imagination explores the connection between the contested 19th century American monument tradition and one of the nation's most revered authors, Herman Melville (1819-1891). The book was written to fill a void in recent Melville scholarship. To date, there has not been a monograph that focuses exclusively on Melville's incorporation of monuments in his fictional world. The book charts the territory of Melville's novels in order to provide a trajectory of the monumental image in one particular literary form. This feature allows the reader to gradually see the monumental image as an important marker that sheds light into Melville's eventual abandonment of long fiction. Melville's Monumental Imagination combines literary analysis and cultural criticism for a long neglected aspect of our nation's iconic development in statuary.
Presenting breakthrough research pertinent to scientists in a wide range of disciplines-from medicine and biotechnology to cosmetics and pharmacy-this Second Edition provides practical approaches to complex formulation problems encountered in the development of particulate delivery systems at the micro- and nano-size level. Completely revised and expanded to represent the most up-to-date studies in the field, this guide covers advances in pulsatile delivery systems, injectable microparticulate systems, and site-specific delivery systems, as well as potential therapeutic applications of nanotechnology.
Edited by two of the most distinguished pioneers in genetic manipulation and bioprocess technology, this bestselling reference presents a comprehensive overview of current cell culture technology used in the pharmaceutical industry. Contributions from several leading researchers showcase the importance of gene discovery and genomic technology development in the production of biotechnology products, tissue engineering, and cell-based therapies. Offering detailed guidance, they cover the steps leading up to the creation of viable therapies including host cell selection, cloning and gene amplification, bioreactor design and operation, protein purification, optimization, scale-up, and facility design.
Research and development of medicines is one of our most challenging, stimulating and successful industrial activities and this book sets out to interest those seeking information about different careers in and associated with the pharmaceutical industry. Since publication of the 1st edition of this book there have been many changes in the environment of medicines research; changes in philosophy, direction, organisation, communication, financing and regulation, reflected here in the updated and additional chapters. The mapping of the human genome, the growth of information technology and the globalisation of medicines research and development to international standards are just some of the changes which have a major impact on the way we perceive and address discovery research, development and the marketing needs of medicines. In addition, as with many other industries, the concept of job for life has been replaced by the need to acquire transferable skills through continuing education and training. For those already in the industry, this book will help maintain a clear focus for career development opportunities in the light of the current structure. While it is not possible to cover all the variants of jobs and opportunities that exist in such a complex industry, it is hoped that enough light is thrown on the different careers in pharmaceuticals to allow those at the start of their working life as well as those seeking a new direction in their career to make the right choice.
This book provides a comprehensive overview of biomotors (molecular motors) within the body with a specific concentration on revolving molecular motors. The bioengineering of these new revolving molecular motors will go a long way in creating machines that will be able to carry RNA and DNA drugs directly to diseased cells to destroy them. The book goes into specific details regarding the bioengineering, fabrication, synthesis, and future utilization of these devices for nanomedicine.
1 R. Levy: Types of Filtration.- 2 T. Meltzer: Modus of Filtration.- 3 O.W. Reif: Microfiltration Membranes: Characteristics and Manufacturing.- 4 M. Jornitz: Filter Constructions and Design.- 5 R. Madsen: Filter Validation.- 6 M. Jornitz: Integrity Testing.-
A follow-up to the experimental and instrumental aspects described in Basic Principles of Analytical Ultracentrifugation, the volume Sedimentation Velocity Analytical Ultracentrifugation: Discrete Species and Size-Distributions of Macromolecules and Particles describes the theory and practice of data analysis. Mathematical models for the sedimentation process and the evolution of detected signals are developed in a comprehensive framework, jointly with the description of current and historical strategies for how to extract from noisy experimental data the physical parameters of interest, such as size, mass, and shape, composition, and polydispersity of sedimenting particles. The methods are extensively illustrated, and supported with practical applications, as well as cross-references where to find the methods in the public domain software SEDFIT and SEDPHAT. The systems covered are discrete or polydisperse mixtures of sedimenting molecules or particles in dilute solution, such as proteins and other biomolecules and their stable complexes, man-made polymers, and nanoparticles, observed in different optical systems. A useful reference for researchers and graduate students of macromolecular disciplines, these methods form the essential foundation for the analysis of dynamic interacting systems, which are covered in the volume Sedimentation Velocity Analytical Ultracentrifugation: Interacting Systems. Software referenced in the book is available for download at: https://sedfitsedphat.nibib.nih.gov/default.aspx
The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this six-volume set compiles data from FDA new drug applications, patent applications, and other sources of generic and proprietary formulations to cover the broad spectrum of GMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.
The Progress in Medicinal Chemistry series spans a wide range of
topics of interest to the drug discovery community. This particular
volume touches upon the following: Elsevier book series on ScienceDirect gives multiple users throughout an institution simultaneous online access to an important compliment to primary research. Digital delivery ensures users reliable, 24-hour access to the latest peer-reviewed content. The Elsevier book series are compiled and written by the most highly regarded authors in their fields and are selected from across the globe using Elsevier's extensive researcher network. For more information about the Elsevier Book Series on
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