Regulatory Aspects of Gene Therapy and Cell Therapy Products

ISBN: 9783031345661
Код товара 155335

Galli

Regulatory Aspects of Gene Therapy and Cell Therapy Products

Regulatory Aspects of Gene Therapy and Cell Therapy Products

ISBN: 9783031345661
Код товара 155335

22 359 ₽

Доставка под заказ

Если Вы закажете книгу до 29.09.2025, то мы привезём её ориентировочно 10.11.2025.

  • Автор

    Galli

  • Издатель

    Springer

  • Тип обложки

    Hardback

  • Размеры

    254 x 178

  • Год издания

    2023

  • ISBN

    9783031345661

  • Язык

    ENG

  • Кол-во страниц

    242

О чём книга?

This book discusses the different regulatory pathways for Advanced Therapy Medicinal Products implemented by national agencies in North and South America, Europe and Asia and by international bodies in the effort of international harmonization. This book represents an update of the first edition, as it covers regulatory novelties and accumulated experience in the regions already addressed. In addition, this new edition offers a wider international perspective: new chapters are included covering Advanced Therapy Medicinal Products regulations in India, Malaysia, Spain and Thailand, the European Pharmacopoeia texts for gene therapy medicinal products as well as international harmonization programs. Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure and therapeutic use of these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of Advanced Therapy Medicinal Products in the areas of product quality, pharmacology and toxicology, clinical trial design and HTA pathways, as well as pertinent ‘must-know’ guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: a Global Perspective is part of the American Society of Gene & Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.

Introduction (MCG and FN).- Updates on ATMP regulations from EU: experience with PRIME procedure and list of approved ATMP.- EU portal for clinical trials application.- European Pharmacopoeia texts on gene therapy medicinal products.- Updates on ATMP regu
Похожие книги
BRS Biochemistry, Molecular Biology, and Genetics
изд. 2025

Emma C. Schoch, Michael A. Lieberman / Эмма С. Шох, Майкл А. Либерман BRS Biochemistry, Molecular Biology, and Genetics

  • ENG
  • изд. 2025
Practical, approachable, and perfect for today’s busy medical students and practitioners, BRS Biochemistry, Molecular Biology, and Genetics, 8th Edition, provides a comprehensive yet concise review to help ensure excellence on class exams and the USMLE Step 1. The renowned Board Review Series outline...
8 750 ₽
Oxford handbook of cardiology
изд. 2025

Oxford handbook of cardiology

  • изд. 2025
6 176 ₽
Campbell-Walsh Urology 13th Edition Review
изд. 2025

Edited by Alan J. Wein, MD, PhD (Hon), FACS, Found / Алана Дж. Вейн Campbell-Walsh Urology 13th Edition Review

  • изд. 2025
Written by the same stellar team that has made Campbell-Walsh-Wein Urology the preeminent text in the field, Campbell-Walsh-Wein Urology Thirteenth Edition Review, 4th Edition, covers all the core material you need to know for board exam preparation and MOC exams. From basic science underpinnings to...
17 178 ₽
Hematopathology
изд. 2025

By Eric D. Hsi, MD, Professor and Chair, Departmen / Эрик Д. Хси Hematopathology

  • изд. 2025
Part of the popular Foundations in Diagnostic Pathology Series, Hematopathology, Fourth Edition, is a practical and affordable resource that is ideal for study and review as well as everyday clinical practice. With its highly templated format, clearly written text, and concise summary tables, this u...
32 337 ₽
Counter-cartographies
изд. 2025

Leon J. Hilton / Леон Хилтон Counter-cartographies

  • ENG
  • изд. 2025
How to remake the world with neurodivergence at its heart What if we embraced neurodivergent ways of being not as deviations to be corrected but as vital ways of inhabiting the world' What new realities might emerge' Bringing a much-needed humanistic perspective to the study of autism and ...
3 386 ₽
ECG made practical, 8 ed
изд. 2025

Hampton, John (emeritus Professor Of Cardiology, U / Джон Хэмптон ECG made practical, 8 ed

  • изд. 2025
For junior doctors, qualified nurses, paramedics and GPs who already understand the basics of the electrocardiogram (ECG), this reference guide will support diagnosis and treatment decisions.The ECG Made Practical, Eighth Edition is a clinically-orientated book, showing how the ECG can help in the d...
5 487 ₽
Аллергия: пособие для врача
изд. 2025

Попова Н.И. Аллергия: пособие для врача

  • RUS
  • изд. 2025
Это практическое пособие написано аллергологом для врачей всех специальностей, которым приходится иметь дело с аллергией. Здесь нет долгих размышлений о патогенезе и длинного списка ссылок с их обсуждением. Только то, что требуется врачу при работе с пациентом. Кратко рассказано, что такое аллерг...
Essentials of General Surgery and Surgical Specialties
изд. 2025

Jessica B O'Connell, Matthew R Smeds, Peter F Lawr / Джессика Б. О'Коннелл, Мэтью Р Essentials of General Surgery and Surgical Specialties

  • ENG
  • изд. 2025
Combining general surgery and the specialties in one volume, Essentials of General Surgery and Surgical Specialties, 7th Edition, focuses on the information all medical students need to know to pass the NBME surgery shelf or other surgery rotation examinations.
 
Lawrence’s popular text offers concise,...
10 809 ₽
Handbook of Dialysis
изд. 2025

John T. Daugirdas, Peter Blake, Todd S. Ing / Джон Т. Даугирдас, Питер Блейк Handbook of Dialysis

  • ENG
  • изд. 2025
Packed with evidence-based, practical information on all aspects of dialysis training and therapy, Handbook of Dialysis, 6th Edition, covers everything from preparation and procedures to surgery, problems, and side effects. Edited by Drs. John T. Daugirdas, Peter G. Blake, and Todd S. Ing, and authored...
10 466 ₽
Bladder Pathology 2e
изд. 2025

Cheng, Liang (Brown University, Providence, RI) Lo / Люн Чинг Bladder Pathology 2e

  • ENG
  • изд. 2025
Understand and diagnose pathologies of the bladder with this essential reference With emphasis on the scientific validation of current diagnostic methods and their direct application in clinical practice, Bladder Pathology is a cutting-edge resource that offers contemporary, comprehensive, and evide...
36 741 ₽