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Pharmaceutical and Medical Device Validation by Experimental Design
by Lynn D. TorbeckThis title demonstrates how designed experiments are the most scientific, efficient, and cost effective method of data collection for validation in a laboratory setting. Intended as a learn-by-example guide, Pharmaceutical and Medical Device Validation by Experimental Design demonstrates why designed experiments are the most logical and rational ap
Pharmaceutical Blending and Mixing
by P. J. Cullen Rodolfo Romañach Nicolas Abatzaglou Chris D. RiellyWritten in four parts, this book provides a dedicated and in-depth reference for blending within the pharmaceutical manufacturing industry. It links the science of blending with regulatory requirements associated with pharmaceutical manufacture. The contributors are a combination of leading academic and industrial experts, who provide an informed and industrially relevant perspective of the topic. This is an essential book for the pharmaceutical manufacturing industry, and related academic researchers in pharmaceutical science and chemical and mechanical engineering.
Pharmaceutical Excipients: Properties, Functionality, and Applications in Research and Industry
by Otilia M. KooThis book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts.* Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development* Describes the physico-chemical properties and biological effects of excipients* Discusses chemical classes, safety and toxicity, and formulation* Addresses recent efforts in the standardization and harmonization of excipients
Pharmaceutical Microbiological Quality Assurance and Control: Practical Guide for Non-Sterile Manufacturing
by David Roesti Marcel GoverdeRelying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Pharmaceutical Microscopy
by Robert Allen CarltonMicroscopy plays an integral role in the research and development of new medicines. Pharmaceutical Microscopy describes a wide variety of techniques together with numerous practical applications of importance in drug development. The first section presents general methods and applications with an emphasis on the physical science aspects. Techniques covered include optical crystallography, thermal microscopy, scanning electron microscopy, energy dispersive x-ray spectrometry, microspectroscopy (infrared and Raman), and particle size and shape by image analysis. The second section presents applications of these techniques to specific topics of pharmaceutical interest, including studies of polymorphism, particle size and shape analysis, and contaminant identification. Pharmaceutical Microscopy is designed for those scientists who must use these techniques to solve pharmaceutical problems but do not need to become expert microscopists. Consequently, each section has exercises designed to teach the reader how to use and apply the techniques in the book. Although the focus is on pharmaceutical development, workers in other fields such as food science and organic chemistry will also benefit from the discussion of techniques and the exercises. Provides comprehensive coverage of key microscopy techniques used in pharmaceutical development Helps the reader to solve specific problems in pharmaceutical quality assuranceOriented and designed for pharmaceutical scientists who need to use microscopy but are not expert microscopistsIncludes a large number of practical exercises to give the reader hands-on experience with the techniquesWritten by an author with 21 years of experience in the pharmaceutical industry
Pharmaceutical Nanobiotechnology for Targeted Therapy (Nanotechnology in the Life Sciences)
by Hamed Barabadi Ebrahim Mostafavi Muthupandian SaravananThe field of nanotechnology for targeted therapy initiated more than decade ago has grown fast and interest is increasing. Given the importance of the field for targeted drug and gene delivery systems, there are a large number of laboratory investigations today researching nanobiomaterials for diagnostic and therapeutic applications. Because of the ability of scientists to load nanoparticles with any agent, interest continues to grow and technology in this arena is rapidly evolving. These emerging nanobiomaterials-based medicines can overcome the disadvantages of traditional medicines by target-oriented and site-specific delivery of precise medicines (immunotherapeutic agents, chemotherapeutic agents, diagnostic agents, and so on). Pharmaceutical Nanobiotechnology for Targeted Therapy presents an updated overview of recent advancements in the field of pharmaceutical nanobiotechnology and nano-based drug and gene delivery systems. This comprehensive knowledge will allow researchers to discover innovative nanobiomaterials for targeted therapeutics. The chapters deal with various emerging nanobiomaterials for targeted therapeutic delivery systems and the writing is in a style that is easily disseminated and in a manner that can be readily adopted as sources for new and further studies. This book should be useful for researchers and professionals from academia and industry working in the field of nanotechnology, nanobiotechnology, as well as in the field of pharmaceutical nanotechnology. It should also be useful to those interested in a range of disciplines from material science, chemistry, molecular biology, polymer chemistry, and many more interdisciplinary areas.
Pharmaceutical Nanotechnology: Innovation and Production, 2 Volumes
by Andrew Owen Arno Kwade Jean Cornier Marcel Van de VoordeWith its focus on concrete methods and recent advances in applying nanotechnology to develop new drug therapies and medical diagnostics, this book provides an overall picture of the field, from the fundamentals of nanopharmacy with the characterisation and manufacturing methods to the role of nanoparticles and substances. Actual examples of utilization include drug development issues, translation to the clinic, market prospects, and industrial commercialization aspects. The applications described are taken from cancer treatment as well as other major therapeutic areas, such as infectious diseases and dermatology. An in-depth discussion on safety, regulatory, and societal aspects rounds off the book. Written by a top team of editors and authors composed of the leading experts in Europe and the USA who have pioneered the field of nanopharmacy!
Pharmaceutical Nanotechnology: Basic Protocols (Methods in Molecular Biology #2000)
by Volkmar Weissig Tamer ElbayoumiThis volume details protocols on formulation, surface modification, characterization, and application of a variety of pharmaceutical nanocarriers such as micelles, nanoparticles, dendrimers, carbon dots, polymersomes, and others. Chapters are targeted toward investigators working in academic and industrial laboratories conducting research in the broad field of pharmaceutical sciences, with an emphasis on drug delivery. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Pharmaceutical Nanotechnology: Basic Protocols aims to be a source of inspiration to all investigators who are interested in the potential of the merger of nanotechnology with pharmaceutical sciences.
Pharmaceutical Process Chemistry
by Takayuki Shioiri Kunisuke Izawa Toshiro KonoikeCovering the whole area of process chemistry in the pharmaceutical industry, this monograph provides the essential knowledge on the basic chemistry needed for future development and key industrial techniques, as well as morphology, engineering and regulatory compliances. Application-oriented and well structured, the authors include recent examples of excellent industrial production of active pharmaceutical ingredients.
Pharmaceutical Supply Chains - Medicines Shortages (Lecture Notes in Logistics)
by João Luís de Miranda Ana Paula Barbosa-Povoa Helena JenzerThis book provides an insight of relevant case studies and updated practices in “PharmaceuticalSupply Chains” (PharmSC) while addressing the most relevant topics within the COST Action “Medicines Shortages” (CA15105).The volume focuses on the most recent developments in the design, planning and scheduling ofPharmSC, broadening from the suppliers’ selection to the impact on patients and healthcaresystems, addressing uncertainty and risk mitigation, and computational issues. It is directed at MSc/PhD students and young researchers (Post-Docs) in Pharmaceutics/Pharmaceutical sciences, Engineering fields, Economics/Management, as well as pharmaceutical decision makers, managers, and practitioners, and advanced readers demanding a fresh approach to decision making for PharmSC. The contributed chapters are associated with the homonymous COST Training Schools (TS), and the book creates a better understanding of the Action “Medicines Shortages” challenges and opportunities.
Pharmaceutical Vendors Approval Manual: A Comprehensive Quality Manual for API and Packaging Material Approval
by Erfan Syed AsifThis book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications. The Pharmaceutical Vendors Approval Manual provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. This book provides a simple, concise and easy to use reference tool covering basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies. It is equally relevant to Quality Assurance officers, Quality Control Analysts, Quality Auditors and other personnel involved in GMP/GLP services in the company. The book will also be beneficial for the institutions conducting Pharmaceutical technology study courses in terms of GMP and GLP applications. This book provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements covers basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry provides ready to use regulatory documentation, e.g. letter of commitment, questionnaire, SOP, etc. required for API and Packaging Materials contract Provided material can be easily tailored to incorporate changes to add in-house vendor’s qualification requirements. Erfan Syed Asif, Ph.D is a Senior Consultant at PharmEng Technology.
Pharmaceuticals in Aquatic Environments: Remediation Technologies and Future Challenges
by Vinod Kumar Garg Ashok Pandey Navish Kataria Caterina FaggioThis book covers pharmaceutical residue dispersion in the aquatic environment and its toxic effect on living organisms. It discusses conventional and advanced remediation technologies such as the use of biomaterials for the sequestration of contaminants, nanotechnology, and phytoremediation. The book includes topics such as the removal of pharmaceutical and personal care product residues from water bodies, green chemistry, and legal regimens for pharmaceuticals in the aquatic environment. It also covers the application of modified biochar in pharmaceutical removal.FEATURES Explores the management of the environment through green chemistry Describes phytoremediation technology for decontamination of pharmaceutical-laden water and wastewater Covers the detection methods and quantification of pharmaceutical residues in various contaminated sources Discusses ecotoxicological aspects and risk assessment of pharmaceuticals in the aquatic environment Reviews degradation and treatment technologies including nanotechnology, biomaterials, and biochar This book is meant for pharmaceutical, toxicology, and environmental science industry experts and researchers.
Pharmaceuticals to Nutraceuticals: A Shift in Disease Prevention
by Dilip Ghosh R. B. SmartaRecently, there has been a fundamental shift in the global health and wellness industry from disease treatment to preventing chronic diseases. The use of nutraceuticals and functional foods in prevention efforts could lead to a decreased dependency on drugs. The pharmaceutical industry recognizes this shift; however, serious concerns have arisen regarding the claimed efficacy, quality, and safety of products used as medical foods. This book examines the consumer and industry mindshift, including the scientific evidence of these foods as effective adjuncts to pharmacotherapy during all stages of treatment of various diseases, thus indicating that pharmaceuticals and nutraceuticals can and should coexist. It details quality, safety, and efficacy of foods, drugs, and nutrients; marketing and product positioning; regulatory perspectives; biomarkers and metabolites; probiotics; food/drug interactions; and future industry trends. In addition, food bioactives represent diet-based molecules that perform physiological roles related to disease prevention and treatment. As such, a considerable overlap exists between food bioactives and drugs—this book presents the case for comparing and contrasting foods versus drugs in several models of health and disease.
Pharmacological Interventions for Osteoporosis (Tissue Repair and Reconstruction)
by Andy H. Choi Sian Yik LimThis book provides readers a fundamental insight into the basic properties of the pharmaceutical agents used in the treatment of osteoporosis. It provides insight into mechanisms of action, updated information on clinical utility, and possible side effects associated with the use of these pharmaceutical agents. In particular, it highlights the use of two monoclonal antibodies romosozumab and denosumab in activating osteoblast differentiation and inhibiting osteoclasts. It also discusses two anabolic pharmaceutical agents, teriparatide and abaloparatide to treat osteoporosis. They have been shown to reduce the incidence of non-vertebral and vertebral fractures significantly after they were administered to patients daily as subcutaneous injections. The content of this book caters to researchers, scientists, and clinical practitioners who are interested in the treatment of osteoporosis using pharmaceutical agents.
Pharmacological Properties of Plant-Derived Natural Products and Implications for Human Health (Advances in Experimental Medicine and Biology #1308)
by George E. Barreto Amirhossein SahebkarMedicinal plants and their derived products remain as an indispensable source of bioactive molecules that serve as either drug candidates or lead compounds for drug design and discovery. There are several advantages for plant-derived therapeutics including wide availability, diverse pharmacological actions and a generally good profile of safety and tolerability. Over the recent years, there have been numerous reports from clinical studies testifying to the efficacy and safety of medicinal plants and phytochemicals in ameliorating several human diseases. A plethora of basic studies has also unravelled molecular mechanisms underlying the health benefits of herbal medicines. Nevertheless, issues such as identification of bioactive ingredients, standardization of the products and drug interactions remain to be further studied. In this book, we aim to put together several chapters on the medicinal properties and pharmacological action of medicinal plants, plant species and phytochemicals. The goal is to present a comprehensive collection on most of the therapeutic aspects of plant-derived natural products and molecular mechanisms thereof.
Pharmacology of Drug Stereoisomers (Progress in Drug Research #76)
by Alexander A. Spasov Igor N. Iezhitsa Pavel M. Vassiliev Alexander A. Ozerov Renu AgarwalThe book is devoted to an important aspect of pharmacology and pharmaceutical chemistry, i.e. the significance of stereoisomerism of drugs for their biological effect from the point of view of their pharmacokinetics, pharmacodynamics and toxicology. The authors review the landmarks in the development of stereochemistry and stereopharmacology. Present-day IUPAC terminology is discussed; general issues of stereoisomerism are considered including separation of racemic mixtures and asymmetric synthesis of isomers, methods of quantifying the isomers of a drug in biological material. The authors put special emphasis on general problems of the influence of stereoisomerism on pharmacological and adverse effects of drugs. A classification of drugs based on stereochemical properties of their isomers is proposed. Possibilities of interaction of stereoisomers in racemic mixtures are discussed. A considerable portion of the book is devoted to pharmacological action of the main groups of drugs whose structure includes asymmetric atoms (that is, drugs with several isomers). Detailed attention is paid to advisability of developing single isomer drugs and to the specifics of their study at the stage of preclinical and clinical trials.
Phase Analysis of Sound Fields: A System-Theoretical Approach
by Mikio TohyamaThis book deals with the phase properties in the context such as sound fields in rooms from a perspective of transfer functions for sound paths. Phase analysis, i.e., investigations of zeros of transfer functions, is a qualitative or system theoretic approach to sound fields rather than the wave-theoretic power spectral analysis. The examination of phase responses offers new insights into sound fields and yields results that the standard power spectral analysis cannot provide. This book presents experimental data and numerical examples based on the mathematical formulations. It shows the mathematical formulations of acoustics and communication systems for engineers and physicists to get familiar with the basics of science. Chapters 1–5 provide the theoretical basis on the system theoretic approach to sound fields where Chapters 1 and 2 are introductions to discrete acoustic systems, Chapters 3–5 summarize wave equations, geometrical and random theories of room acoustics, and Chapters 6–10 develop details of transfer functions in sound.
Phase Behavior of Two-Dimensional Water Confined in Graphene Nanocapillaries (Springer Theses)
by YinBo ZhuIn this book, the authors use molecular dynamics simulations to conduct a comprehensive study of the compression/superheating limit and phase transition of 2D (monolayer, bilayer, and trilayer) water/ice constrained in graphene nanocapillaries. When subjected to nanoscale confinement and under ultrahigh pressure, water and ice behave quite differently than their bulk counterparts, partly because the van der Waals pressure can spark a water-to-ice transformation, known as the metastability limit of two-dimensional (2D) liquids. From a mechanical standpoint, this liquid-to-solid transformation characterizes the compression limit (or metastability limit) of 2D water. The findings presented here could help us to better understand the phase behavior of 2D confined water/ice.
Phase Change Material-Based Heat Sinks: A Multi-Objective Perspective
by Srikanth Rangarajan C. BalajiPhase-change Material based heat sinks and associated optimization remains a topic of great interest, as evident from the increasing number of citations and new applications and miniaturization. Often the multi objective perspective of such heat sinks is ignored. This book introduces the readers to the PCM based heat sinks and Multi objective optimization. The authors have also included interesting in house experimental results on the "Rotating heat sinks" which is a first of a kind work. Useful to budding thermal researchers and practicing engineers in the field, this book is also a great start for students to understand the cooling applications in electronics and an asset to every library in a technical university. Since this book not only gives a critical review of the state of the art but also presents the authors' own results. The book will encourage, motivate and let the reader consider pursuing a research career in electronic cooling technologies.
Phase Change Materials for Energy Management and Efficiency
by Seyed Mojtaba SadrameliThis book explores the prospective applications of Phase Change Materials (PCMs) in energy storage systems, thermal system temperature control, peak shifting, and energy management. It starts with definitions and a brief history of energy storage systems, followed by an exploration of different types of PCMs, encapsulation techniques, heat transfer enhancement methods, and the applications and challenges of PCMs. The book provides a comprehensive overview of PCM applications in building envelopes, free cooling, electrical appliances, lithium-ion batteries, textiles, solar panels, vehicles and logistics, and more across 14 chapters.• Demonstrates various techniques for the enhancement of energy storage systems.• Offers an applied approach.• Discusses energy management, thermal control, peak shifting, energy conservation, and energy storage.Aimed at researchers in industrial manufacturing sectors, it can also serve as a resource for undergraduate and graduate students in energy management courses. In addition, this reference is valuable for engineers and scientists focused on energy optimization and the application of sustainable materials.
Phase Change Materials for Thermal Energy Management and Storage: Fundamentals and Applications (Emerging Materials and Technologies)
by Hafiz Muhammad AliPhase Change Materials for Thermal Energy Management and Storage: Fundamentals and Applications provides the latest advances in thermal energy applications of phase change materials (PCMs). It introduces definitions and offers a brief history, and then delves into preparation techniques, thermophysical properties and heat transfer characteristics with mathematical models, performance-affecting factors, and applications and challenges of PCMs.Features Provides key heat transfer enhancement and thermophysical properties features for a wide range of PCMs. Presents detailed parameter selection procedures impacting heat transfer. Reviews available prediction methods for heat transfer and thermophysical properties of PCMs. Discusses practical applications for enhanced thermal control. Explores challenges and potential opportunities for heat transfer enhancement. This reference offers a comprehensive overview of the fundamentals, technologies, and current and near-future applications of PCMs for thermal energy management and storage for researchers and advanced students in materials, mechanical, and related fields of engineering.
Phase Diagrams and Physical Properties of Nonequilibrium Alloys: A Supplement to Landolt-Börnstein III/37 Series
by Yoshiyuki Kawazoe Ursula Carow-WatamuraThis handbook presents the data of 5-component metallic amorphous alloys, including a large number of specimen obtained by adding a 5-th component to a quaternary alloy, some were obtained by starting from lower component base alloys, and there are a few examples of so-called high-entropy alloys.It contributes both to fundamental researches and industrial applications.
Phase Equilibria: Measurement & Computation
by Andreas L. Muhlbauer J. David RaalThis work provides coverage of experimental and theoretical procedures for vapour-liquid equilibria (VLE). A survey of the different models and approaches in recent literature enables the reader to choose the appropriate action.
Phase Equilibria Diagrams of High Temperature Non-oxide Ceramics
by Zhenkun Huang Laner WuThis book explores new experimental phase diagrams of non-oxide ceramics, with a particular focus on the silicon nitride, silicon carbide and aluminum nitride, as well as the ultra-high temperature ceramic (UHTC) systems. It features more than 80 experimental phase diagrams of these non-oxide ceramics, including three phase diagrams of UHTC systems, constructed by the authors. Physical chemistry data covering the period since the 1970s, collected by the author Z.K.Huang, is presented in six tables in the appendixes. It also includes 301 figures involving about 150 material systems. Most of the phase diagrams have been selected from the ACerS-NIST database with copyright permission. The book methodically presents numerous diagrams previously scattered in various journals and conferences worldwide. Providing extensive experimental data, it is a valuable reference resource on ceramics development and design for academic researchers, R&D engineers and graduate students.
Phase Equilibria in Ionic Liquid Facilitated Liquid-Liquid Extractions
by Anand Bharti Debashis Kundu Dharamashi Rabari Tamal BanerjeeThis book provides a comprehensive overview of ionic liquid based separation techniques. The glimpse of thermodynamic predictive models along with global optimization techniques will help readers understand the separation techniques at molecular and macroscopic levels. Experimental and characterization techniques are coupled with model based predictions so as to provide multicomponent data for the scientific community. The models will focus more on the a-priori based predictions which gives higher emphasis on hydrogen-bonded systems. Particle Swarm Optimization (PSO) technique will also eventually help the readers to apply optimization technique to an extraction process. The overriding goal of this work is to provide pathways for leading engineers and researchers toward a clear understanding and firm grasp of the phase equilibria of Ionic Liquid systems.