Biomedical Product Development Bench To Bedside

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Biomedical Product Development: Bench to Bedside

Babak Arjmand,Moloud Payab,Parisa Goodarzi
Biomedical Product Development Bench to Bedside Book PDF

Author : Babak Arjmand,Moloud Payab,Parisa Goodarzi
Publisher : Springer Nature
Page : 164 pages
File Size : 50,9 Mb
Release : 2020-02-05
Category : Medical
ISBN : 9783030356262

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Biomedical Product Development: Bench to Bedside by Babak Arjmand,Moloud Payab,Parisa Goodarzi Pdf

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.

Ophthalmic Product Development

Seshadri Neervannan,Uday B. Kompella
Ophthalmic Product Development Book PDF

Author : Seshadri Neervannan,Uday B. Kompella
Publisher : Springer Nature
Page : 650 pages
File Size : 49,6 Mb
Release : 2022-03-11
Category : Medical
ISBN : 9783030763671

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Ophthalmic Product Development by Seshadri Neervannan,Uday B. Kompella Pdf

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;}

Cell Biology and Translational Medicine, Volume 16

Kursad Turksen
Cell Biology and Translational Medicine Volume 16 Book PDF

Author : Kursad Turksen
Publisher : Springer Nature
Page : 197 pages
File Size : 41,9 Mb
Release : 2022-07-28
Category : Science
ISBN : 9783031106385

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Cell Biology and Translational Medicine, Volume 16 by Kursad Turksen Pdf

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.

Biomedical Product and Materials Evaluation

P.V. Mohanan
Biomedical Product and Materials Evaluation Book PDF

Author : P.V. Mohanan
Publisher : Woodhead Publishing
Page : 808 pages
File Size : 46,7 Mb
Release : 2022-01-22
Category : Technology & Engineering
ISBN : 9780128241738

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Biomedical Product and Materials Evaluation by P.V. Mohanan Pdf

Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation. This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology. Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies Discusses standardization and ethical hurdles in biomedical product development and how to overcome them

Cell Biology and Translational Medicine, Volume 17

Kursad Turksen
Cell Biology and Translational Medicine Volume 17 Book PDF

Author : Kursad Turksen
Publisher : Springer Nature
Page : 249 pages
File Size : 40,5 Mb
Release : 2022-11-01
Category : Science
ISBN : 9783031205149

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Cell Biology and Translational Medicine, Volume 17 by Kursad Turksen Pdf

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.

Biofertilizers

Inamuddin,Mohd Imran Ahamed,Rajender Boddula,Mashallah Rezakazemi
Biofertilizers Book PDF

Author : Inamuddin,Mohd Imran Ahamed,Rajender Boddula,Mashallah Rezakazemi
Publisher : John Wiley & Sons
Page : 690 pages
File Size : 51,5 Mb
Release : 2021-08-03
Category : Technology & Engineering
ISBN : 9781119724674

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Biofertilizers by Inamuddin,Mohd Imran Ahamed,Rajender Boddula,Mashallah Rezakazemi Pdf

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.

Biomedical Applications of Electrospinning and Electrospraying

Naresh Kasoju,Hua Ye
Biomedical Applications of Electrospinning and Electrospraying Book PDF

Author : Naresh Kasoju,Hua Ye
Publisher : Woodhead Publishing
Page : 484 pages
File Size : 54,5 Mb
Release : 2021-05-05
Category : Medical
ISBN : 9780128224908

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Biomedical Applications of Electrospinning and Electrospraying by Naresh Kasoju,Hua Ye Pdf

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

Principles of Translational Science in Medicine

Martin Wehling
Principles of Translational Science in Medicine Book PDF

Author : Martin Wehling
Publisher : Academic Press
Page : 364 pages
File Size : 47,6 Mb
Release : 2015-04-02
Category : Science
ISBN : 9780128007211

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Principles of Translational Science in Medicine by Martin Wehling Pdf

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

Bioactive Components

Monika Thakur,Tarun Belwal
Bioactive Components Book PDF

Author : Monika Thakur,Tarun Belwal
Publisher : Springer Nature
Page : 609 pages
File Size : 44,6 Mb
Release : 2022-12-01
Category : Technology & Engineering
ISBN : 9789811923661

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Bioactive Components by Monika Thakur,Tarun Belwal Pdf

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.

Development of FDA-Regulated Medical Products

Elaine Whitmore
Development of FDA Regulated Medical Products Book PDF

Author : Elaine Whitmore
Publisher : Quality Press
Page : 257 pages
File Size : 47,8 Mb
Release : 2012-02-15
Category : Medical
ISBN : 9780873892216

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Development of FDA-Regulated Medical Products by Elaine Whitmore Pdf

Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia—regardless of functional specialty, workplace, or seniority—who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution—from bench to bedside—has become known as translational research and development, and this approach is what this book illuminates. "I have been working in medical device design and design assurance for over 10 years...Elaine Whitmore really gets this right...The point is that quality regulations are not going to go away, and those responsible for healthcare product development will have to lead the charge to keep up the momentum in their organizations. I am going to have to buy several copies of this for my clients!" Joseph P. Sener, P.E.

Using Animal Models in Biomedical Research

Pierce K. H. Chow,Robert T. H. Ng,Bryan E. Ogden
Using Animal Models in Biomedical Research Book PDF

Author : Pierce K. H. Chow,Robert T. H. Ng,Bryan E. Ogden
Publisher : World Scientific
Page : 309 pages
File Size : 44,9 Mb
Release : 2008
Category : Medical
ISBN : 9789812706638

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Using Animal Models in Biomedical Research by Pierce K. H. Chow,Robert T. H. Ng,Bryan E. Ogden Pdf

Animal models play crucial roles in the continuum of experimental activities that make up biomedical research. This book fills this gap in knowledge and provides material not easily sourced by the average biomedical researcher, such as current information biosafety, animal protocal design and histological-pathological support.

Design of Biomedical Devices and Systems, 4th edition

Paul H. King,Richard C. Fries,Arthur T. Johnson
Design of Biomedical Devices and Systems 4th edition Book PDF

Author : Paul H. King,Richard C. Fries,Arthur T. Johnson
Publisher : CRC Press
Page : 725 pages
File Size : 53,9 Mb
Release : 2018-10-03
Category : Medical
ISBN : 9780429786051

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Design of Biomedical Devices and Systems, 4th edition by Paul H. King,Richard C. Fries,Arthur T. Johnson Pdf

This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated. Features Provides updated material as needed to each chapter Incorporates new examples and applications within each chapter Discusses new material related to entrepreneurship, clinical trials and CRISPR Relates critical new information pertaining to FDA regulations. Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments Presents multiple case examples of entrepreneurship in this field Addresses multiple safety and ethical concerns for the design of medical devices and processes

Empathy

Jean Decety
Empathy Book PDF

Author : Jean Decety
Publisher : MIT Press
Page : 335 pages
File Size : 46,7 Mb
Release : 2014-01-10
Category : Psychology
ISBN : 9780262525954

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Empathy by Jean Decety Pdf

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.

Real-World Evidence in Medical Product Development

Weili He,Yixin Fang,Hongwei Wang
Real World Evidence in Medical Product Development Book PDF

Author : Weili He,Yixin Fang,Hongwei Wang
Publisher : Springer Nature
Page : 431 pages
File Size : 47,9 Mb
Release : 2023-05-11
Category : Mathematics
ISBN : 9783031263286

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Real-World Evidence in Medical Product Development by Weili He,Yixin Fang,Hongwei Wang Pdf

This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standard for the evaluation of efficacy and safety of medical products. However, the cost, duration, practicality, and limited generalizability have incentivized many to look for alternative ways to optimize drug development. This book provides a comprehensive list of topics together to include all aspects with the uptake of RWE/D, including, but not limited to, applications in regulatory and non-regulatory settings, causal inference methodologies, organization and infrastructure considerations, logistic challenges, and practical use cases.

Stem Cells and Lineage Commitment

Kursad Turksen
Stem Cells and Lineage Commitment Book PDF

Author : Kursad Turksen
Publisher : Springer Nature
Page : 228 pages
File Size : 47,6 Mb
Release : 2023-12-09
Category : Science
ISBN : 9781071635377

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Stem Cells and Lineage Commitment by Kursad Turksen Pdf

This detailed volume explores a variety of techniques used to study lineage commitment in stem cells. Further elucidation of the process that stem cells undergo on their way to becoming more specified cell types is vital for a more complete understanding of cell biology and overall physiology. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step and readily reproducible laboratory protocols, as well as tips on troubleshooting and avoiding known pitfalls. Authoritative and practical, Stem Cells and Lineage Commitment: Methods and Protocols serves as an ideal guide for experts and novices in the field of stem cell biology.