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Fundamentals of Biologicals Regulation

Fundamentals of Biologicals Regulation
Vaccines and Biotechnology Medicines

by Rebecca Sheets

  • Publisher : Academic Press
  • Release : 2017-12-13
  • Pages : 450
  • ISBN : 0128094435
  • Language : En, Es, Fr & De
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Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals. Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products

Fundamentals of Pharmaceutical and Biologics Regulations, Third Edition

Fundamentals of Pharmaceutical and Biologics Regulations, Third Edition
A Book

by Gloria Hall

  • Publisher : Unknown Publisher
  • Release : 2020-07-29
  • Pages : 129
  • ISBN : 9781947493513
  • Language : En, Es, Fr & De
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Fundamentals of Canadian Pharmaceutical, Biologic and Medical Device Regulations

Fundamentals of Canadian Pharmaceutical, Biologic and Medical Device Regulations
A Book

by Gloria Hall

  • Publisher : Unknown Publisher
  • Release : 2019-04-16
  • Pages : 129
  • ISBN : 9781947493292
  • Language : En, Es, Fr & De
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Fundamentals of US Regulatory Affairs

Fundamentals of US Regulatory Affairs
10th Edition

by Syed Rizwanuddin Ahmad,Cassie Alexander,Berry Berger,Mitchell Berger,Peggy Berry,Charles Breen,David Brindley,Fernando Henrique X. de Brito,Elizabeth Campbell,Kell Canon,Carol Cooper,Pallavi Sharma Das,Sunny Kamlesh Dave,Seameen Dehdashti,Cindy DiBiasi,Jim DiBiasi,Joy Frestedt,Abhishek Gurnani,Robert Guzman,Michael Hinckle,Karen Jaffe,Jocelyn Jennings,Angela Johnnson,Kurt Karst,Allison Komiyama,Mona Koshkouei,Carrie Kuehn,Evangeline Loh,Demetra Macheras,Robert Martin,Nancy Mathewson,Kirsten Messmer,Bernard Naughton,Tina O'Brien,Valerie Ramsey,Sarah Robinson,Joanne Rupprecht,Alexandra Beumer Sassi,Kathrin Scalper,Charity-Anne Schuller,Kandarp Shah,William Sietsema,Andrew Slade,James Smith,Edward Steele,Ashhish Talati,Nancy Teague,Snehal Trivedi,Gresham Weatherly,Martha Wells,Jennifer Wilhelm,Holly Winchell,Linda Yang

  • Publisher : Unknown Publisher
  • Release : 2017-07
  • Pages : 129
  • ISBN : 9780997769777
  • Language : En, Es, Fr & De
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An Overview of FDA Regulated Products

An Overview of FDA Regulated Products
From Drugs and Cosmetics to Food and Tobacco

by Eunjoo Pacifici,Susan Bain

  • Publisher : Academic Press
  • Release : 2018-06-13
  • Pages : 280
  • ISBN : 0128111569
  • Language : En, Es, Fr & De
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Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations

Advances in Nanomedicine for the Delivery of Therapeutic Nucleic Acids

Advances in Nanomedicine for the Delivery of Therapeutic Nucleic Acids
A Book

by Surendra Nimesh,Ramesh Chandra,Nidhi Gupta

  • Publisher : Woodhead Publishing
  • Release : 2017-04-04
  • Pages : 256
  • ISBN : 0081005636
  • Language : En, Es, Fr & De
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Advances in Nanomedicine for the Delivery of Therapeutic Nucleic Acids addresses several issues related to safe and effective delivery of nucleic acids (NAs) using nanoparticles. A further emphasis would be laid on the mechanism of delivery of NAs, the barriers encountered and the strategies adapted to combat them. An exhaustive account of the advantages as well shortcomings of all the delivery vectors being employed in delivery of various NAs will be provided. On final note the regulatory aspects of nanoparticles mediated NA would be discussed, with focus on their clinical relevance. The design and development of nucleic acid-based therapeutics for the treatment of diseases arising from genetic abnormalities has made significant progress over the past few years. NAs have been widely explored for the treatment of cancer and infectious diseases or to block cell proliferation and thereby caused diseases. Advances in synthetic oligonucleotide chemistry resulted in synthesis of NAs that are relatively stable in in vivo environments. However, cellular targeting and intracellular delivery of NAs still remains a challenge. Further development of NA-based therapeutics depends on the progress of safe and effective carriers for systemic administration. Nanomedicine has facilitated availability of vectors with diminished cytotoxicity and enhanced efficacy which are rapidly emerging as systems of choice. These vectors protect NAs from enzymatic degradation by forming condensed complexes along with targeted tissue and cellular delivery. During the past few years, a myriad reports have appeared reporting delivery of NAs mediated by nanoparticles. This book will provide an overview of nanoparticles being employed in the in vitro and in vivo delivery of therapeutically relevant NAs like DNA, siRNA, LNA, PNA, etc. Provides a complete overview of the applicatiosn of nanomedicine in the delivery of nucleic acids, from characterization of nanoparticles, to in vitro and in vivo studies Discusses delivery issues of less well explored nucleic acids, like PNAs, Ribozymes, DNAzymes, etc. Summarizes the current state of research in nucleic acid delivery and underscores the future of nanomedicine in this field

New Horizons in Health-Promoting Technologies: From Development to Rational Use

New Horizons in Health-Promoting Technologies: From Development to Rational Use
A Book

by Luciane Cruz Lopes,Cristiane De Cássia Bergamaschi,Silvio Barberato-Filho,Marcus Tolentino Silva,Brian Godman

  • Publisher : Frontiers Media SA
  • Release : 2020-10-08
  • Pages : 129
  • ISBN : 2889660435
  • Language : En, Es, Fr & De
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Fundamentals of Law and Regulation: An in-depth look at foods, veterinary medicines, and cosmetics

Fundamentals of Law and Regulation: An in-depth look at foods, veterinary medicines, and cosmetics
A Book

by Robert P. Brady

  • Publisher : Fdli
  • Release : 1997
  • Pages : 533
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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American Pharmacy: Fundamental principles and practices. Pharmaceutical preparations. Biologicals

American Pharmacy: Fundamental principles and practices. Pharmaceutical preparations. Biologicals
A Book

by Rufus Ashley Lyman

  • Publisher : Unknown Publisher
  • Release : 1945
  • Pages : 129
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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American Pharmacy ...: Fundamental principles and practices. Pharmaceutical preparations. Biologicals. -2. Advanced pharmacy. Medical, surgical and dental supplies. Animal health pharmacy

American Pharmacy ...: Fundamental principles and practices. Pharmaceutical preparations. Biologicals. -2. Advanced pharmacy. Medical, surgical and dental supplies. Animal health pharmacy
A Book

by Rufus Ashley Lyman

  • Publisher : Unknown Publisher
  • Release : 1945
  • Pages : 129
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Fundamentals of Hazardous Materials Incidents

Fundamentals of Hazardous Materials Incidents
A Book

by Reginald Campbell,R. Everett Langford

  • Publisher : CRC Press
  • Release : 2020-10-14
  • Pages : 472
  • ISBN : 100011497X
  • Language : En, Es, Fr & De
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This book evolved from the course developed at the U.S. Department of Labor's National Mine, Health, and Safety Academy to develop the legislation that eventually became 29 CFR 1910.120. Fundamentals of Hazardous Materials Incidents offers the reader a basic understanding of the principles involved in toxicology, federal regulations, respiratory protection, personal protective equipment, radiation, environmental considerations, industrial hygiene sampling, site safety, and chemically resistant suits. Thousands of people have been trained using this manual, now revised and available for the first time in hardcover format. The book is essential for identifying potential problems at hazardous waste sites, covers diverse topics throughout the area of hazardous materials response, and is ideal for training courses to meet 29 CFR 1910.120 requirements. Quantity discounts available.

The Pineal Gland and Its Hormones

The Pineal Gland and Its Hormones
Fundamentals and Clinical Perspectives

by Franco Fraschini,Russel J. Reiter,Bojidar Stankov

  • Publisher : Springer Science & Business Media
  • Release : 2012-12-06
  • Pages : 233
  • ISBN : 146151911X
  • Language : En, Es, Fr & De
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This volume contains the written contributions to the proceedings of a workshop related to the pineal gland and its hormones, which was held in Erice, Italy, on June 7 -June 13, 1994. This series of workshops, which began in 1982 and which have been held at four-year intervals since that time, has provided important continuity for advancing the state of knowledge relating to this very important investigative area. The enthusiasm for these conferences has increased steadily, as reflected in the number of individuals applying to attend and in the input of individuals who participate in the meeting. The 1994 meeting was important because of its timeliness. In the two years preceding the meeting a number of revolutionary discoveries were made relative to the actions of the pineal hormone melatonin. The Xenopus melatonin receptor was cloned, melatonin was demonstrated to be a potent antioxidant, the significance of melatonin receptors at the level of pars tuberalis in the regulation of the hypothalamo-pituitary-gonadal axis was questioned, a number of melatonin receptor analogues were discovered and successfully utilized, the mechanisms by which melatonin retards initiation and promotion of cancer was further elucidated, the clinical aspects of the pineal gland was re-scrutinized. Reviews relating to each of these subjects, as well as many others, are contained in this proceedings book. This volume represents an up-to-date repository for the most recent information related to this rapidly advancing field.

Fundamentals of Animal Cell Encapsulation and Immobilization

Fundamentals of Animal Cell Encapsulation and Immobilization
A Book

by Mattheus F. A. Goosen

  • Publisher : CRC Press
  • Release : 1992-11-10
  • Pages : 336
  • ISBN : 9780849359446
  • Language : En, Es, Fr & De
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Fundamentals of Animal Cell Encapsulation and Immobilization is a concise reference volume that consolidates and expands our understanding of animal cell immobilization technology. The book presents fundamental studies that examine polymer toxicity, biocompatibility, mass transfer, and modeling of cell growth and diffusion. Specific applications of encapsulation to Parkinson's Disease are discussed in detail, and droplet generation and scale-up information will benefit researchers attempting to scale-up their cell immobilization systems. Fundamentals of Animal Cell Encapsulation and Immobilization provides valuable information for industrial and biomedical researchers involved in animal cell immobilization, as well as for materials scientists, biochemists, microbiologists, biologists, and biochemical engineering students who wish to specialize in cell encapsulation.

Fundamentals of Pharmacology for Veterinary Technicians

Fundamentals of Pharmacology for Veterinary Technicians
A Book

by Janet Amundson Romich,Sarah Wagner

  • Publisher : Cengage Learning
  • Release : 2020-02-25
  • Pages : 736
  • ISBN : 0357461649
  • Language : En, Es, Fr & De
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Romich’s FUNDAMENTALS OF PHARMACOLOGY FOR VETERINARY TECHNICIANS, 3E demonstrates how the best veterinary technicians succeed on the frontlines of animal patient care through effective drug administration. Following a body-systems approach, chapters cover important drugs, their actions and potentially adverse effects, diseases, dosing, and delivery -- all with the goal of developing a deeper understanding of drugs used in veterinary care. To bring practice into the classroom, chapters also explore veterinary technician roles and duties, dosage calculations, legal requirements, pharmacy management, clinical tips and more. And the MindTap platform offers extra digital resources such as practice quizzes, games, drug updates for better success in the classroom and on the VTNE certification exam. Important Notice: Media content referenced within the product description or the product text may not be available in the ebook version.

Fundamentals of Drug Delivery

Fundamentals of Drug Delivery
A Book

by Heather A. E. Benson,Michael S. Roberts,Adrian C. Williams,Xiaowen Liang

  • Publisher : John Wiley & Sons
  • Release : 2021-10-26
  • Pages : 592
  • ISBN : 1119769604
  • Language : En, Es, Fr & De
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A comprehensive guide to the current research, major challenges, and future prospects of controlled drug delivery systems Controlled drug delivery has the potential to significantly improve therapeutic outcomes, increase clinical benefits, and enhance the safety of drugs in a wide range of diseases and health conditions. Fundamentals of Drug Delivery provides comprehensive and up-to-date coverage of the essential principles and processes of modern controlled drug delivery systems. Featuring contributions by respected researchers, clinicians, and pharmaceutical industry professionals, this edited volume reviews the latest research in the field and addresses the many issues central to the development of effective, controlled drug delivery. Divided in three parts, the book begins by introducing the concept of drug delivery and discussing both challenges and opportunities within the rapidly evolving field. The second section presents an in-depth critique of the common administration routes for controlled drug delivery, including delivery through skin, the lungs, and via ocular, nasal, and otic routes. The concluding section summarizes the current state of the field and examines specific issues in drug delivery and advanced delivery technologies, such as the use of nanotechnology in dermal drug delivery and advanced drug delivery systems for biologics. This authoritative resource: Covers each main stage of the drug development process, including selecting pharmaceutical candidates and evaluating their physicochemical characteristics Describes the role and application of mathematical modelling and the influence of drug transporters in pharmacokinetics and drug disposition Details the physiology and barriers to drug delivery for each administration route Presents a historical perspective and a look into the possible future of advanced drug delivery systems Explores nanotechnology and cell-mediated drug delivery, including applications for targeted delivery and toxicological and safety issues Includes comprehensive references and links to the primary literature Edited by a team of of internationally-recognized experts, Fundamentals of Drug Delivery is essential reading for researchers, industrial scientists, and advanced students in all areas of drug delivery including pharmaceutics, pharmaceutical sciences, biomedical engineering, polymer and materials science, and chemical and biochemical engineering.

Fundamentals of Human Physiology

Fundamentals of Human Physiology
A Book

by Giovanni Cavagna

  • Publisher : Springer
  • Release : 2020-08-14
  • Pages : 249
  • ISBN : 9783030194062
  • Language : En, Es, Fr & De
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This textbook explores the fundamental qualitative and quantitative aspects of human physiology. It approaches biological and physiological processes and phenomena from a quantitative perspective, revealing how physiological problems can be mathematically formulated starting from simple laws of physics. The book addresses a broad range of topics, including: the statics and dynamics of circulation; muscle and sarcomere force-length and force-velocity relations, together with their mechanisms and functional consequences; subdivisions and meaning of the heat produced by muscle; locomotion, statics and dynamics of respiration; diffusion of gases and acid base equilibrium; phonation; general functions of the kidney and of the different sections of the nephron; changes in clearance with a substance’s plasmatic concentration; pH regulation and the kidney; Donnan’s equilibrium and its consequences; and the Nernst equation. The book offers the ideal learning resource for students of human physiology courses in medicine and biomedicine, as well as biomedical engineering and biophysics graduate students. An elementary grasp of mathematics and physics is sufficient to understand the content.

Fundamentals of Pharmacology for Children's Nurses

Fundamentals of Pharmacology for Children's Nurses
A Book

by Ian Peate,Peter Dryden

  • Publisher : John Wiley & Sons
  • Release : 2021-10-25
  • Pages : 448
  • ISBN : 1119633214
  • Language : En, Es, Fr & De
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Registered Nurses must have thorough knowledge of pharmacology, medicines administration, and the effects of medicines. Fundamentals of Pharmacology for Children's Nurses is written for nurses and allied health professionals involved in the care of children and young people (CYP) to focus exclusively on pharmacology. Filling a gap in current literature on the subject, this much-needed resource develops the competence and confidence required to prescribe, dispense, and administer medicines to children and young people. Emphasising the importance of patient-centered care to CYP, the text describes the role of the healthcare provider working with CYP and their families; explains how to use pharmaceutical and prescribing reference guides; discusses legal and ethical issues; examines pharmacodynamics and pharmacokinetics, and more. Helping readers respond appropriately and compassionately to the needs of those receiving care and their families, this textbook: Covers a wide range of medications used in diabetes, cancer, mental health, and other areas Features a wealth of full-colour images and numerous pedagogical tools including learning objectives, self-test questions, and reflective exercises to enable readers to contextualise and assess their knowledge Presents case studies to reinforce learning, and illustrate the application of theory to practice Provides authoritative and practical guidance on formulations, adverse drug reactions, analgesics, antibiotics, immunisations, and the medications most commonly used when providing care to CYP Includes access to a companion website with interactive MCQs, case studies, references, an image bank, and links to further reading and supplemental resources Fundamentals of Pharmacology for Children's Nurses is essential reading for undergraduate children’s nursing students, trainee nursing associates, those undertaking healthcare programmes of study, as well as those seeking to better understand pharmacology.

Fundamentals of Entomology

Fundamentals of Entomology
A Book

by Richard J. Elzinga

  • Publisher : Prentice Hall
  • Release : 1987
  • Pages : 456
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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The Fundamentals of Life Sciences Law

The Fundamentals of Life Sciences Law
Drugs, Devices, and Biotech

by David J. Bloch

  • Publisher : Unknown Publisher
  • Release : 2007
  • Pages : 502
  • ISBN : 9781422439753
  • Language : En, Es, Fr & De
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Frontiers in Tissue Engineering

Frontiers in Tissue Engineering
A Book

by C.W. Patrick,A.G. Mikos,L.V. McIntire

  • Publisher : Elsevier
  • Release : 1998-02-20
  • Pages : 700
  • ISBN : 9780080532059
  • Language : En, Es, Fr & De
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Frontiers in Tissue Engineering is a carefully edited compilation of state-of-the-art contributions from an international authorship of experts in the diverse subjects that make up tissue engineering. A broad representation of the medical, scientific, industrial and regulatory community is detailed in the book. The work is an authoritative and comprehensive reference source for scientists and clinicians working in this emerging field. The book is divided into three parts: fundamentals and methods of tissue engineering, tissue engineering applied to specialised tissues, and tissue engineering applied to organs. The text offers many novel approaches, including a detailed coverage of cell-tissue interactions at cellular and molecular levels; cell-tissue surface, biochemical, and mechanical environments; biomaterials; engineering design; tissue-organ function; new approaches to tissue-organ regeneration and replacement of function; ethical considerations of tissue engineering; and government regulation of tissue-engineered products.