Fundamentals of Biologicals Regulation

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  • Publisher : Academic Press
  • Release : 13 December 2017
  • ISBN : 9780128094433
  • Page : 450 pages
  • Rating : 4.5/5 from 103 voters

Fundamentals of Biologicals Regulation Book PDF summary

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

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Fundamentals of Biologicals Regulation

Fundamentals of Biologicals Regulation
  • Author : Rebecca Sheets
  • Publisher : Academic Press
  • Release Date : 2017-12-13
  • ISBN : 9780128094433
DOWNLOAD 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 Pharmaceutical and Biologics Regulations, Third Edition

Fundamentals of Pharmaceutical and Biologics Regulations, Third Edition
  • Author : Gloria Hall
  • Publisher : Unknown
  • Release Date : 2020-07-29
  • ISBN : 1947493515
DOWNLOAD BOOKFundamentals of Pharmaceutical and Biologics Regulations, Third Edition

Fundamentals of US Regulatory Affairs

Fundamentals of US Regulatory Affairs
  • Author : 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
  • Release Date : 2017-07
  • ISBN : 0997769777
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Regulatory Aspects of Gene Therapy and Cell Therapy Products

Regulatory Aspects of Gene Therapy and Cell Therapy Products
  • Author : Maria Cristina Galli,Mercedes Serabian
  • Publisher : Springer
  • Release Date : 2015-09-15
  • ISBN : 9783319186184
DOWNLOAD BOOKRegulatory Aspects of Gene Therapy and Cell Therapy Products

This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). 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 for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for

Dale's Pharmacology Condensed E-Book

Dale's Pharmacology Condensed E-Book
  • Author : Clive P. Page,Simon Pitchford
  • Publisher : Elsevier Health Sciences
  • Release Date : 2019-12-25
  • ISBN : 9780702078194
DOWNLOAD BOOKDale's Pharmacology Condensed E-Book

Covering the essential basic science and principles of pharmacology using concise text and diagrams, Dale’s Pharmacology Condensed, 3rd Edition, presents the key facts and concepts that are key to understanding how drugs work and their underlying pathophysiological processes. Each of the 50 short chapters provides an organized, consistent approach to efficient learning and retention of complex information. This concise text is an ideal companion volume to Rang and Dale’s Pharmacology, as well as a stand-alone condensed textbook or review

Fundamentals of US Regulatory Affairs

Fundamentals of US Regulatory Affairs
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2013
  • ISBN : OCLC:1301971528
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Sharing Clinical Trial Data

Sharing Clinical Trial Data
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
  • Publisher : National Academies Press
  • Release Date : 2015-04-20
  • ISBN : 9780309316323
DOWNLOAD BOOKSharing Clinical Trial Data

Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade
  • Author : World Intellectual Property Organization
  • Publisher : WIPO
  • Release Date : 2013
  • ISBN : 9789280523089
DOWNLOAD BOOKPromoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade

This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

An Introduction to Molecular Biotechnology

An Introduction to Molecular Biotechnology
  • Author : Michael Wink
  • Publisher : John Wiley & Sons
  • Release Date : 2013-11-14
  • ISBN : 9783527672035
DOWNLOAD BOOKAn Introduction to Molecular Biotechnology

Molecular biotechnology continues to triumph, as this textbook testifies - edited by one of the academic pioneers in the field and written by experienced professionals. This completely revised second edition covers the entire spectrum, from the fundamentals of molecular and cell biology, via an overview of standard methods and technologies, the application of the various "-omics", and the development of novel drug targets, right up to the significance of system biology in biotechnology. The whole is rounded off by an

FDA Regulatory Affairs

FDA Regulatory Affairs
  • Author : David Mantus,Douglas J. Pisano
  • Publisher : CRC Press
  • Release Date : 2014-02-28
  • ISBN : 9781841849195
DOWNLOAD BOOKFDA Regulatory Affairs

FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the

Biologics, Biosimilars, and Biobetters

Biologics, Biosimilars, and Biobetters
  • Author : Iqbal Ramzan
  • Publisher : John Wiley & Sons
  • Release Date : 2021-01-05
  • ISBN : 9781119564669
DOWNLOAD BOOKBiologics, Biosimilars, and Biobetters

A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such

An Overview of FDA Regulated Products

An Overview of FDA Regulated Products
  • Author : Eunjoo Pacifici,Susan Bain
  • Publisher : Academic Press
  • Release Date : 2018-06-13
  • ISBN : 9780128111567
DOWNLOAD 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

Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems
  • Author : Ashok Katdare,Mahesh Chaubal
  • Publisher : CRC Press
  • Release Date : 2006-07-28
  • ISBN : 9781420004137
DOWNLOAD BOOKExcipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems

To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new excipients to be developed and approved continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge new avenue

Guide for the Care and Use of Laboratory Animals

Guide for the Care and Use of Laboratory Animals
  • Author : National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Committee for the Update of the Guide for the Care and Use of Laboratory Animals
  • Publisher : National Academies Press
  • Release Date : 2011-01-27
  • ISBN : 9780309154000
DOWNLOAD BOOKGuide for the Care and Use of Laboratory Animals

A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane

Safe Management of Wastes from Health-care Activities

Safe Management of Wastes from Health-care Activities
  • Author : A. Prüss,Eric Giroult,Philip Rushbrook
  • Publisher : World Health Organization
  • Release Date : 1999
  • ISBN : 9241545259
DOWNLOAD BOOKSafe Management of Wastes from Health-care Activities