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Fundamentals of Biologicals Regulation, By Rebecca Sheets, PhD, CAPT (Retired), USPHS, Pri


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Автор: By Rebecca Sheets, PhD, CAPT (Retired), USPHS, Pri
Название:  Fundamentals of Biologicals Regulation
ISBN: 9780443219887
Издательство: Elsevier Science
Классификация:


ISBN-10: 0443219885
Обложка/Формат: Paperback
Страницы: 450
Вес: 0.45 кг.
Дата издания: 01.11.2025
Издание: 2 ed
Размер: 235 x 191
Подзаголовок: Vaccines and biotechnology medicines
Ссылка на Издательство: Link
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Поставляется из: Европейский союз
Описание: Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines, Second Edition serves as an introduction to the international regulatory arena in which biologicals are developed, offering an overview of processes and insights into the scientific concepts underpinning global regulations. The book provides in-depth coverage of Quality by Design, Combination Products, Quality Target Product Profiles, Risk Management Plans, REMS, and switching from reliance on in vivo to in vitro analytical methods. It reflects new developments and processes accelerated by the COVID-19 vaccine experience, including emergency use authorizations and conditional marking authorizations. New pedagogic elements and case studies have been added to improve learning outcomes.This book provides multiple levels of readership, with guidance on basic concepts, a detailed look at regulatory challenges, and practical insights into how regulators consider regulatory science and regulatory process issues across various regions, with an emphasis on the European Medicines Agency and the U.S. Food and Drug Administration.
Дополнительное описание: Feature new chapters on Advanced Therapy Medicinal Products (including cell and gene therapies), Combination Products, and PharmacovigilancePresents new and updated case studies, including lessons learned from the development of COVID VaccinesProvides mor


      Старое издание
Fundamentals of Biologicals Regulation

Автор: Sheets, Rebecca
Название: Fundamentals of Biologicals Regulation
ISBN: 0128092904 ISBN-13(EAN): 9780128092903
Издательство: Elsevier Science
Цена: 132500 T
Наличие на складе: Поставка под заказ.
Описание:

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.



Introductory Physics for Biological Scientists

Автор: Aegerter Christof M.
Название: Introductory Physics for Biological Scientists
ISBN: 1108466508 ISBN-13(EAN): 9781108466509
Издательство: Cambridge Academ
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Цена: 66530.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: An introduction to the fundamental physical principles related to the study of biological phenomena. Chapters are structured around biological examples, and the topics covered include waves, optics and mechanics. With quiz questions and a detailed appendix, it is perfect for students looking to develop their quantitative and analytical tools.

Sabiston Textbook Of Surgery International Edition

Автор: Townsend, Courtney M. et al.
Название: Sabiston Textbook Of Surgery International Edition
ISBN: 032364063X ISBN-13(EAN): 9780323640633
Издательство: Elsevier Science
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Цена: 111010.00 T
Наличие на складе: Поставка под заказ.

Understanding the Biological Basis of Behavior: Developing Evidence-Based Interventions for Clinical, Counseling and School Psychologists

Автор: D`Amato Rik Carl, Davis Andrew S., Power Elizabeth
Название: Understanding the Biological Basis of Behavior: Developing Evidence-Based Interventions for Clinical, Counseling and School Psychologists
ISBN: 3030591611 ISBN-13(EAN): 9783030591618
Издательство: Springer
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Цена: 83850.00 T
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Описание: Introduction and Foundations of Clinical Practice.- Understanding the past, present, and future of clinical neuropsychology for professional practice.- Understanding the development of the central nervous system and its relationship to clinical practice.- The importance of understanding functional neuroanatomy.- Understanding neurodevelopment in children and adults.- Neuroimaging and neurodiagnostic procedures.- Assessment for Intervention in Clinical, Counseling, and School Psychology.- Using a standardized model to guide assessment for interventions.- Integrated assessments for intervention in clinical neuropsychology.- Qualitative assessment in clinical neuropsychology.- Using Research to Guide our Neuropsychologically Based Clinical Practice.- Designing single subject-based interventions for clinical neuropsychology practice.- Designing Qualitative Research-Based Interventions for clinical neuropsychology practice.- Designing quantitative research-based interventions for clinical neuropsychology practice.- Interventions Driven by Brain-Based Understanding.- Understanding and using psychopharmacology in clinical practice.- Neurospsychologically driven evidence-based interventions in clinical neuropsychology.- Neuropsychologically driven evidence-based interventions in counseling psychology.- Neuropsychologically driven evidence-based interventions in school psychology.- What we need to learn about the biological basis of behavior for clinical practice.- Appendix A: three sample case reports.


Textbook of Biological Psychiatry

Автор: Jaak Panksepp
Название: Textbook of Biological Psychiatry
ISBN: 0471434787 ISBN-13(EAN): 9780471434788
Издательство: Wiley
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Цена: 194250.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This comprehensive reference examines the biochemistry of neurotransmission, behavioral pharmacology and clinical aspects of psychiatric problems including depression, manic-depression, and mood disorders. Other chapters address the biological mechanisms and treatment of depression, anxiety, panic, obsessive-compulsive disorder, and addictions.

Successful Scientific Writing.A Step-by-Step Guide for the Biological and Medical Sciences

Автор: Matthews, Janice R. (Scientific Editing Services) Matthews, Robert W. (University of Georgia)
Название: Successful Scientific Writing.A Step-by-Step Guide for the Biological and Medical Sciences
ISBN: 1107691931 ISBN-13(EAN): 9781107691933
Издательство: Cambridge Academ
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Цена: 36960.00 T
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Описание: The new edition of this best-selling guide has been thoroughly updated for today`s digital world, covering all aspects of the writing process and now including extensive coverage of ethical issues, including plagiarism. It offers a rich blend of practical advice, abundant examples from actual manuscripts, and hands-on exercises.

Organic chemistry with biological applications

Автор: Mcmurry, John
Название: Organic chemistry with biological applications
ISBN: 128584291X ISBN-13(EAN): 9781285842912
Издательство: Cengage Learning
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Цена: 85530.00 T
Наличие на складе: Нет в наличии.
Описание: Provides coverage of the foundations of organic chemistry - enhanced by biological examples throughout. This book discusses the organic chemistry behind biological pathways.

Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches

Автор: Ward Kevin R., Matejtschuk Paul
Название: Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches
ISBN: 1493989278 ISBN-13(EAN): 9781493989270
Издательство: Springer
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Цена: 110870.00 T
Наличие на складе: Есть
Описание: This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector - whether these be therapeutics, vaccines or diagnostic products - and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab.

Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field.


Plant Protection: From Chemicals to Biologicals

Автор: Deep Chandra Suyal, Ravindra Soni, Reeta Goel
Название: Plant Protection: From Chemicals to Biologicals
ISBN: 3110771470 ISBN-13(EAN): 9783110771473
Издательство: Walter de Gruyter
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Цена: 241680.00 T
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Описание:

Phyto-pathogens are one of the dominating components which badly affect crop production. In light of the global food demand, sustainable agricultural plans utilizing agrochemicals became necessary. The role of beneficial microbes in the defense priming of host plants has been well documented. This book details new aspects of microbial-assisted plant protection and their role in agricultural production, economy, and environmental sustainability.


Plant Protection: From Chemicals to Biologicals

Автор: Deep Chandra Suyal, Ravindra Soni, Reeta Goel
Название: Plant Protection: From Chemicals to Biologicals
ISBN: 3110771632 ISBN-13(EAN): 9783110771633
Издательство: Walter de Gruyter
Рейтинг:
Цена: 172320.00 T
Наличие на складе: Нет в наличии.
Описание:

Phyto-pathogens are one of the dominating components which badly affect crop production. In light of the global food demand, sustainable agricultural plans utilizing agrochemicals became necessary. The role of beneficial microbes in the defense priming of host plants has been well documented. This book details new aspects of microbial-assisted plant protection and their role in agricultural production, economy, and environmental sustainability.


Quality Control and Regulatory Aspects for Biologicals: Regulations and Best Practices

Автор: Misra, Gauri
Название: Quality Control and Regulatory Aspects for Biologicals: Regulations and Best Practices
ISBN: 1032697407 ISBN-13(EAN): 9781032697406
Издательство: Taylor&Francis
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Цена: 99010.00 T
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Combined Discrete and Continual Approaches  in Biological Modelling

Автор: Alexander E. Filippov; Stanislav N. Gorb
Название: Combined Discrete and Continual Approaches in Biological Modelling
ISBN: 3030415279 ISBN-13(EAN): 9783030415273
Издательство: Springer
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Цена: 102480.00 T
Наличие на складе: Поставка под заказ.
Описание: In spite of diversity of biological systems considered, two main questions are (1) what does self-organization in biology mean mathematically and (2) how one can apply this knowledge to generate new knowledge about behavior of particular biological system?

Contact Problems for Soft, Biological and Bioinspired Materials

Автор: Borodich Feodor M., Jin Xiaoqing
Название: Contact Problems for Soft, Biological and Bioinspired Materials
ISBN: 3030851745 ISBN-13(EAN): 9783030851743
Издательство: Springer
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Цена: 167700.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book contains contributions from leading researchers in biomechanics, nanomechanics, tribology, contact mechanics, materials science and applications on various experimental techniques including atomic force microscopy (AFM) for studying soft, biomimetic and biological materials and objects. Biologists, physicists, researchers applying methods of contact mechanics and researchers testing materials using indentation techniques along with many other applied scientists will find this book a useful addition to their libraries. Moreover, several reviews in this book are written as introductions to several important and rather sophisticated research areas such as depth-sensing indentation, studying of biological cells by AFM probes, mechanics of adhesive contact and contact between viscoelastic (hereditary elastic) solids. The book containing new theoretical models, results of experimental studies and numerical simulations, along with reviews of above mentioned areas of contact mechanics in application to biological systems, would be beneficial for researchers in many areas of biology, medicine, engineering, mechanics and biomimetics.


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