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Biomedical Product Development: Bench to Bedside

Author : Babak Arjmand
Publisher : Springer Nature
Page : 164 pages
File Size : 10,21 MB
Release : 2020-02-05
Category : Medical
ISBN : 3030356264

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This textbook covers all the steps in manufacturing a biomedical product from bench to bedside. It specifically focuses on quality assurance and management and explains the different good practice principles in the various phases of product development as well as how to fulfill them: Good laboratory practice, good manufacturing practice and good clinical practice. It provides readers with the know-how to design biomedical experiments to ensure quality and integrity, to plan and conduct standard preclinical studies and to assure the quality of the final manufactured biomedical products. Importantly, it also addresses ethical concerns and considerations. The book discusses the guidelines and ethical considerations for preclinical and clinical studies, to allow readers to identify safety concerns regarding biomedical products and to improve pre-clinical studies for the development of better products. This textbook is a valuable guide for biomedical students (B.Sc., M.S., and Ph.D. students) in the field of molecular medicine, medical biotechnology, stem cell research and related areas, as well as for professionals such as quality control staff, tissue bankers, policy-makers and health professionals.

Cell Biology and Translational Medicine, Volume 16

Author : Kursad Turksen
Publisher : Springer Nature
Page : 197 pages
File Size : 25,58 MB
Release : 2022-07-28
Category : Science
ISBN : 3031106385

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Much research has focused on the basic cellular and molecular biological aspects of stem cells. Much of this research has been fueled by their potential for use in regenerative medicine applications, which has in turn spurred growing numbers of translational and clinical studies. However, more work is needed if the potential is to be realized for improvement of the lives and well-being of patients with numerous diseases and conditions. This book series 'Cell Biology and Translational Medicine (CBTMED)' as part of Springer Nature’s longstanding and very successful Advances in Experimental Medicine and Biology book series, has the goal to accelerate advances by timely information exchange. Emerging areas of regenerative medicine and translational aspects of stem cells are covered in each volume. Outstanding researchers are recruited to highlight developments and remaining challenges in both the basic research and clinical arenas. This current book is the 16th volume of a continuing series. Chapter "Epithelial Stem Cells: Making, Shaping and Breaking the Niche" is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.

Ophthalmic Product Development

Author : Seshadri Neervannan
Publisher : Springer Nature
Page : 650 pages
File Size : 32,17 MB
Release : 2022-03-11
Category : Medical
ISBN : 3030763676

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This is a comprehensive textbook addressing the unique aspects of drug development for ophthalmic use. Beginning with a perspective on anatomy and physiology of the eye, the book provides a critical appraisal of principles that underlie ocular drug product development. The coverage encompasses topical and intraocular formulations, small molecules and biologics (including protein and gene therapies), conventional formulations (including solutions, suspensions, and emulsions), novel formulations (including nanoparticles, microparticles, and hydrogels), devices, and specialty products. Critical elements such as pharmacokinetics, influence of formulation technologies and ingredients, as well as impact of disease conditions on products development are addressed. Products intended for both the front and the back of the eye are discussed with an eye towards future advances. @font-face {font-family:"Cambria Math"; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:0; mso-generic-font-family:roman; mso-font-pitch:variable; mso-font-signature:3 0 0 0 1 0;}@font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4; mso-font-charset:0; mso-generic-font-family:swiss; mso-font-pitch:variable; mso-font-signature:-469750017 -1073732485 9 0 511 0;}p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:""; margin:0cm; mso-pagination:widow-orphan; font-size:12.0pt; font-family:"Times New Roman",serif; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}.MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-family:"Calibri",sans-serif; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}div.WordSection1 {page:WordSection1;}

Principles of Translational Science in Medicine

Author : Martin Wehling
Publisher : Academic Press
Page : 365 pages
File Size : 35,58 MB
Release : 2015-04-02
Category : Science
ISBN : 0128007214

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Principles of Translational Science in Medicine: From Bench to Bedside, Second Edition, provides an update on major achievements in the translation of research into medically relevant results and therapeutics. The book presents a thorough discussion of biomarkers, early human trials, and networking models, and includes institutional and industrial support systems. It also covers algorithms that have influenced all major areas of biomedical research in recent years, resulting in an increasing numbers of new chemical/biological entities (NCEs or NBEs) as shown in FDA statistics. The book is ideal for use as a guide for biomedical scientists to establish a systematic approach to translational medicine. Provides an in-depth description of novel tools for the assessment of translatability of trials to balance risk and improve projects at any given stage of product development New chapters deal with translational issues in the fastest growing population (the elderly), case studies, translatability assessment tools, and advances in nanotherapies Details IPR issues of translation, especially for public-private-partnerships Contains contributions from world leaders in translational medicine, including the former NIH director and authorities from various European regulatory institutions

Cell Biology and Translational Medicine, Volume 17

Author : Kursad Turksen
Publisher : Springer Nature
Page : 249 pages
File Size : 28,22 MB
Release : 2022-11-01
Category : Science
ISBN : 3031205146

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Much research has focused on the basic cellular and molecular biological aspects of stem cells. Much of this research has been fueled by their potential for use in regenerative medicine applications, which has in turn spurred growing numbers of translational and clinical studies. However, more work is needed if the potential is to be realized for improvement of the lives and well-being of patients with numerous diseases and conditions. This book series 'Cell Biology and Translational Medicine (CBTMED)' as part of Springer Nature’s longstanding and very successful Advances in Experimental Medicine and Biology book series, has the goal to accelerate advances by timely information exchange. Emerging areas of regenerative medicine and translational aspects of stem cells are covered in each volume. Outstanding researchers are recruited to highlight developments and remaining challenges in both the basic research and clinical arenas. This current book is the 17th volume of a continuing series.

Biomedical Devices

Author : Raymond H. W. Lam
Publisher : Springer
Page : 379 pages
File Size : 50,27 MB
Release : 2019-08-16
Category : Medical
ISBN : 3030242374

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This textbook provides essential knowledge for biomedical product development, including material properties, fabrication processes and design techniques for different applications, as well as process design and optimization. This book is multidisciplinary and readers can learn techniques to apply acquired knowledge for various applications of biomedical design. Further, this book encourages readers to discover and convert newly reported technologies into products and services for the future development of biomedical applications. This is an ideal book for upper-level undergraduate and graduate students, engineers, technologists, and researchers working in the area of biomedical engineering and manufacturing. This book also: Provides a comprehensive set of fundamental knowledge for engineering students and entry level engineers to design biomedical devices Offers a unique approach to manufacturing of biomedical devices by integrating and formulating different considerations in process design tasks into optimization problems Provides a broad range of application examples to guide readers through the thinking process of designing and manufacturing biomedical devices, from basic understanding about the requirements and regulations to a set of manufacturing parameters

Biofertilizers

Author : Inamuddin
Publisher : John Wiley & Sons
Page : 690 pages
File Size : 47,60 MB
Release : 2021-08-03
Category : Technology & Engineering
ISBN : 1119724678

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Great attention has been paid to reduce the use of conventional chemical fertilizers harming living beings through food chain supplements from the soil environment. Therefore, it is necessary to develop alternative sustainable fertilizers to enhance soil sustainability and agriculture productivity. Biofertilizers are the substance that contains microorganisms (bacteria, algae, and fungi) living or latent cells that can enrich the soil quality with nitrogen, phosphorous, potassium, organic matter, etc. They are a cost-effective, biodegradable, and renewable source of plant nutrients/supplements to improve the soil-health properties. Biofertilizers emerge as an attractive alternative to chemical fertilizers, and as a promising cost-effective technology for eco-friendly agriculture and a sustainable environment that holds microorganisms which enhance the soil nutrients' solubility leading a raise in its fertility, stimulates crop growth and healthy food safety. This book provides in-depth knowledge about history and fundamentals to advances biofertilizers, including latest reviews, challenges, and future perspectives. It covers fabrication approaches, and various types of biofertilizers and their applications in agriculture, environment, forestry and industrial sectors. Also, organic farming, quality control, quality assurance, food safety and case-studies of biofertilizers are briefly discussed. Biofertilizers' physical properties, affecting factors, impact, and industry profiles in the market are well addressed. This book is an essential guide for farmers, agrochemists, environmental engineers, scientists, students, and faculty who would like to understand the science behind the sustainable fertilizers, soil chemistry and agroecology.

Empathy

Author : Jean Decety
Publisher : MIT Press
Page : 335 pages
File Size : 37,92 MB
Release : 2012
Category : Psychology
ISBN : 0262016613

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Recent work on empathy theory, research, and applications, by scholars from disciplines ranging from neuroscience to psychoanalysis. There are many reasons for scholars to investigate empathy. Empathy plays a crucial role in human social interaction at all stages of life; it is thought to help motivate positive social behavior, inhibit aggression, and provide the affective and motivational bases for moral development; it is a necessary component of psychotherapy and patient-physician interactions. This volume covers a wide range of topics in empathy theory, research, and applications, helping to integrate perspectives as varied as anthropology and neuroscience. The contributors discuss the evolution of empathy within the mammalian brain and the development of empathy in infants and children; the relationships among empathy, social behavior, compassion, and altruism; the neural underpinnings of empathy; cognitive versus emotional empathy in clinical practice; and the cost of empathy. Taken together, the contributions significantly broaden the interdisciplinary scope of empathy studies, reporting on current knowledge of the evolutionary, social, developmental, cognitive, and neurobiological aspects of empathy and linking this capacity to human communication, including in clinical practice and medical education.

Biomedical Applications of Electrospinning and Electrospraying

Author : Naresh Kasoju
Publisher : Woodhead Publishing
Page : 484 pages
File Size : 27,16 MB
Release : 2021-05-05
Category : Medical
ISBN : 0128224908

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Biomedical Applications of Electrospinning and Electrospraying describes the principles and laboratory set up for electrospinning and electrospraying, addressing a range of biomedical applications. Sections cover novel combinational approaches, such as electrospinning/spraying and 3D printing. Electrospinning has evolved from being a technique to prepare random networks of textile fibers to a technique to fabricate highly ordered patterns of biomedical materials of defined scale. The technological advancements in recent years with regard to the way the jet is facilitated, how the jet path is controlled, and how the fibers are collected have provided invaluable insights into controlled fabrication of a material of choice. Additionally, the electrospray technique has also evolved from being a technique to prepare food formulations to a technique to prepare cell encapsulated beads for transplantation in clinics. Several innovations in this line, such as those leading to core-shell materials have tremendously changed the way the technique is used. Thus, a combinational approach using electrospinning, electrospraying and 3D printing has emerged. Introduces electrospinning and electrospraying concepts and describes state-of-the-art methodologies Provides comprehensive coverage of electrospun/spray materials in drug delivery, tissue engineering and biosensor applications Presents details of instrumentation involved, along with novel devices for bench to bedside translation, Covers novel combinational approaches using electrospinning, electrospraying and 3D printingIntroduces electrospinning and electrospraying concepts and describes state-of-the-art methodologies Provides comprehensive coverage of electrospun/spray materials in drug delivery, tissue engineering and biosensor applications Presents details of instrumentation involved, along with novel devices for bench to bedside translation Covers novel combinational approaches using electrospinning, electrospraying and 3D printing

Bioactive Components

Author : Monika Thakur
Publisher : Springer Nature
Page : 609 pages
File Size : 30,5 MB
Release : 2022-12-01
Category : Technology & Engineering
ISBN : 9811923663

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This book compiles updated information about the role and health benefits of various bioactives in food. Different chapters are contributed by academicians, food scientists, technologists, and medical practitioners. The book addresses both theoretical and applied aspects of bioactive components and provides exhaustive knowledge about bioactive components. It comprises 27 chapters organized into 4 major sections covering topics in food science and technology, functional foods, and nutraceuticals. It provides perspectives for innovation, sources, applications, and sustainability in bioactive component research. The first section starts with introduction of bioactive components consisting of seven different chapters primarily focusing on the bioactive components and their sources with respective health benefits. The second section, comprising five different chapters, deals with different technological trends, regulations, and safety aspects of bioactive components. With eight chapters, the third section covers the role of bioactive components in human health and the role of functional foods in combating various health-related issues. The fourth section reviews functional foods through six chapters that cover the use of bioactive components in various food products. The book will prove useful to advanced food technology graduate and undergraduate students and research scholars, practicing food technologists in food and related industries, entrepreneurs, food-pharma researchers, and other scientists seeking information about smart and sustainable processes as well as information needed to design and develop these processes.