Fundamentals of Biologicals Regulation

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

Produk Detail:

  • Author : Rebecca Sheets
  • Publisher : Academic Press
  • Pages : 450 pages
  • ISBN : 0128094435
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKFundamentals of Biologicals Regulation

Fundamentals of Biologicals Regulation

Fundamentals of Biologicals Regulation
  • Author : Rebecca Sheets
  • Publisher : Academic Press
  • Release : 13 December 2017
GET THIS BOOKFundamentals of Biologicals Regulation

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

Fundamentals of International Pharmaceutical and Biologics Regulations

Fundamentals of International Pharmaceutical and Biologics Regulations
  • Author : Zeeshaan Arshad,Nicole Beard,David Brindley,Orin Chisholm,Rosie Dawes,Elizabeth Goldstein,Ceine-Lea Halioua-Haubold,Nathalie Innocent,Colin Jacob,Jocelyn Jennings,Mona Koshkouei,Bernard Naughton,Megumi Nozawa,Terrance Ocheltree,Kathrin Schalper,William Sietsema,David Silberstein,James Smith,James Ware,Lin Wu
  • Publisher : Unknown Publisher
  • Release : 04 March 2021
GET THIS BOOKFundamentals of International Pharmaceutical and Biologics Regulations

An Overview of FDA Regulated Products

An Overview of FDA Regulated Products
  • Author : Eunjoo Pacifici,Susan Bain
  • Publisher : Academic Press
  • Release : 13 June 2018
GET THIS BOOKAn Overview of FDA Regulated Products

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

Basic Fundamentals of Drug Delivery

Basic Fundamentals of Drug Delivery
  • Author : Anonim
  • Publisher : Academic Press
  • Release : 30 November 2018
GET THIS BOOKBasic Fundamentals of Drug Delivery

Basic Fundamentals of Drug Delivery covers the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable drug delivery system. The book also covers various approaches involved in optimizing the therapeutic performance of a biomolecule while designing its appropriate advanced formulation. Provides up-to-date information on translating the physicochemical properties of drugs into drug delivery systems Explores how drugs are administered via various routes,

Biological Drug Products

Biological Drug Products
  • Author : Wei Wang,Manmohan Singh
  • Publisher : John Wiley & Sons
  • Release : 29 August 2013
GET THIS BOOKBiological Drug Products

Tested and proven solutions to the challenges of biologicaldrug product development Biological drug products play a central role in combating humandiseases; however, developing new successful biological drugspresents many challenges, including labor intensive productionprocesses, tighter regulatory controls, and increased marketcompetition. This book reviews the current state of the science,offering readers a single resource that sets forth the fundamentalsas well as tested and proven development strategies for biologicaldrugs. Moreover, the book prepares readers for the challenges thattypically arise during drug development,

Fundamentals of Food Biotechnology

Fundamentals of Food Biotechnology
  • Author : Byong H. Lee
  • Publisher : John Wiley & Sons
  • Release : 01 December 2014
GET THIS BOOKFundamentals of Food Biotechnology

Food biotechnology is the application of modern biotechnologicaltechniques to the manufacture and processing of food, for examplethrough fermentation of food (which is the oldest biotechnologicalprocess) and food additives, as well as plant and animal cellcultures. New developments in fermentation and enzyme technologicalprocesses, molecular thermodynamics, genetic engineering, proteinengineering, metabolic engineering, bioengineering, and processesinvolving monoclonal antibodies, nanobiotechnology and quorumsensing have introduced exciting new dimensions to foodbiotechnology, a burgeoning field that transcends many scientificdisciplines. Fundamentals of Food Biotechnology, 2nd edition is basedon the

Principles and Practice of Clinical Research

Principles and Practice of Clinical Research
  • Author : John I. Gallin,Frederick P. Ognibene
  • Publisher : Academic Press
  • Release : 04 March 2021
GET THIS BOOKPrinciples and Practice of Clinical Research

The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply

Fundamentals of US Regulatory Affairs, Eighth Edition

Fundamentals of US Regulatory Affairs, Eighth Edition
  • Author : Alix E. Alderman,Pamela Anne Jones,Patricia Anderson,Regulatory Affairs Professionals Society,Alay Bhayani,Clawson Bowman,Evelyn D. Cadman,Rafael Cassata,Melissa Cavuto,Ojas Chandorkar,Min Chen,Joseph C. Fratantoni,Klaus Gottlieb,Michael R. Hamrell,Donna Helms,Nigel A. S. Hernandez,Hutch Humphreys,Treena Jackson,Karen Jaffe,Jocelyn Jennings,Allison Kennedy,William H. Kitchens,Tatiana Leshchinsky,Alan Minsk,Brian Miyazaki,Linda Pollitz,M. Prasad Palthur,Giuseppe Randazzo,Matthew Rycyk,Srikonda Sastry,Anthony P. Schiavone,Jessica W. Smith,Michelle Sotak,Usha Srinivasan,Michael A. Swit,Mya Thomae,Anne Tomalin,Laurence M. Wallman,Maria Walsh,Diane R. Whitworth,Sherry Yanez Gregor,Linda Yang,Andrew P. Zeltwanger,Jeffrey Zinza
  • Publisher : Unknown Publisher
  • Release : 30 June 2013
GET THIS BOOKFundamentals of US Regulatory Affairs, Eighth Edition