Pharmaceutical Regulatory Affairs
Principles and Practices
-
20% KEDVEZMÉNY?
- A kedvezmény csak az 'Értesítés a kedvenc témákról' hírlevelünk címzettjeinek rendeléseire érvényes.
- Kiadói listaár GBP 140.00
-
66 885 Ft (63 700 Ft + 5% áfa)
Az ár azért becsült, mert a rendelés pillanatában nem lehet pontosan tudni, hogy a beérkezéskor milyen lesz a forint árfolyama az adott termék eredeti devizájához képest. Ha a forint romlana, kissé többet, ha javulna, kissé kevesebbet kell majd fizetnie.
- Kedvezmény(ek) 20% (cc. 13 377 Ft off)
- Kedvezményes ár 53 508 Ft (50 960 Ft + 5% áfa)
Iratkozzon fel most és részesüljön kedvezőbb árainkból!
Feliratkozom
66 885 Ft
Beszerezhetőség
Még nem jelent meg, de rendelhető. A megjelenéstől számított néhány héten belül megérkezik.
Why don't you give exact delivery time?
A beszerzés időigényét az eddigi tapasztalatokra alapozva adjuk meg. Azért becsült, mert a terméket külföldről hozzuk be, így a kiadó kiszolgálásának pillanatnyi gyorsaságától is függ. A megadottnál gyorsabb és lassabb szállítás is elképzelhető, de mindent megteszünk, hogy Ön a lehető leghamarabb jusson hozzá a termékhez.
A termék adatai:
- Kiadás sorszáma 1
- Kiadó CRC Press
- Megjelenés dátuma 2025. december 26.
- ISBN 9781032944876
- Kötéstípus Keménykötés
- Terjedelem341 oldal
- Méret 280x210 mm
- Nyelv angol
- Illusztrációk 10 Illustrations, black & white; 24 Illustrations, color; 34 Line drawings, color; 56 Tables, color 700
Kategóriák
Rövid leírás:
This book provides an overview of drug development and regulatory affairs covering the lifecycle from discovery to market approval, global trade impacts, and regulatory frameworks. It explores clinical testing guidelines, bioethics, and pharmacovigilance. This book is valuable for professionals and researchers of pharmaceutical sciences.
TöbbHosszú leírás:
This book provides concepts, procedures, guidelines, and regulatory affairs in drug development. Pharmaceutical Regulatory Affairs: Principles and Practices begins with a detailed overview of the drug development life cycle, from initial discovery and preclinical research to clinical trials and market approval, addressing scientific, regulatory, and ethical considerations at each stage. The book covers the evolution of global trade agreements like the General Agreement on Tariff and Trades (GATT) and the World Trade Organization’s (WTO) impact on pharmaceuticals, highlighting issues surrounding pharmaceutical patents and intellectual property rights. It discusses the importance of the Scale-Up and Post-Approval Changes (SUPAC) guidelines in ensuring quality and consistency in drug manufacturing post-approval and examines the World Health Organization's (WHO) guidelines on technology development and transfer. The fundamentals of regulatory affairs are covered, emphasizing the roles and responsibilities of regulatory professionals. The book provides an in-depth look at regulatory frameworks of major agencies worldwide, including the Central Drugs Standard Control Organization (CDSCO) in India, the Food and Drug Administration (FDA) in the US, the European Medicines Agency (EMA) in the EU, the Therapeutic Goods Administration (TGA) in Australia, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, Health Canada, and regulatory authorities in emerging markets. It also addresses the international regulatory landscape for medical devices and reviews foundational pharmaceutical regulations. Additionally, the text explores regulatory guidelines for clinical testing, including the roles and responsibilities under pharmaceutical legislation, principles of bioethics and biosafety, the digital transformation in clinical trials, and the critical role of pharmacovigilance. The book concludes with an examination of the global regulatory scenario for pharmaceutical excipients, providing a detailed roadmap through the complexities of drug development, regulatory compliance, and global standards. This book is valuable for professionals, researchers, and students of pharmaceutical sciences.
TöbbTartalomjegyzék:
Chapter1. Stages and Processes in Drug Development and Discovery. Chapter 2. The WTO and its Impact on Pharmaceuticals. Chapter 4. Pharmaceutical Patents and IPR. Chapter 5. Understanding the Scale-Up and Post-Approval Changes (SUPAC) Guidelines. Chapter 6. WHO Guidelines on Technology Development & Transfer. Chapter 7. Fundamentals of Regulatory Affairs in Pharmaceuticals. Chapter 8. Regulatory Framework of the Central Drugs Standard Control Organization (CDSCO) in India. Chapter 9. Regulatory Overview of the U.S Food and Drug Administration (FDA). Chapter 10. Regulatory Framework of the European Medicines Agency (EMA) and EU Member States. Chapter 11. Regulatory Processes of the Therapeutic Good Administration (TGA) in Australia. Chapter 12. Regulatory Landscape of the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Chapter 13. Health Canada's Regulatory Framework for Pharmacueticals. Chapter 14. Regulatory Sciences in Emerging Markets of Rest of The World (Row). Chapter 15. International Regulatory Authorities for Medical Devices. Chapter 16. Regulatory Overview: Indian Drugs and Cosmetics Act of 1940 and Rules of 1945. Chapter 17. Responsibilities and Functions Under Pharmaceutical Legislation. Chapter 18. Principles of Bioethics and Biosafety in Pharmaceuticals. Chapter 19. Digital Transformation in Clinical Trials and Research. Chapter 20. Pharmacovigilance: Ensuring safety in clinical trials. Chapter 21. Regulatory Scenario of Excipients Worldwide. Chapter 22. Innovation through Renovation: Navigating Regulatory Framework and Technical Challenges of Drug Repositioning.
Több
European Union Law: Cases and Materials
19 110 Ft
17 199 Ft
Praxishandbuch der Immobilien-Projektentwicklung: Akquisition, Konzeption, Realisierung, Vermarktung
57 650 Ft
