Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices Book

Name: Development of FDA-Regulated Medical Products: Prescription Drugs
Brand: ASQ Quality Press
SKU: 9780873896139
Price: 99.99 USD
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Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices, Many changes to the classification and regulation of prescription drugs, biologics, and medical devices have occurred since the previous edition of this book was published in 1997 under the title Product Development Planning for Health Care Products Regul, Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices

3 out of 5 stars based on 2 reviews

Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices
Written by author Elaine Whitmore
Published by ASQ Quality Press, December 2003
Many changes to the classification and regulation of prescription drugs, biologics, and medical devices have occurred since the previous edition of this book was published in 1997 under the title Product Development Planning for Health Care Products Regul
The revised edition of a volume first published in 1997 as Product Development for Health Care Products Regulated by the FDA is intended as a foundation for anyone involved in developing pharmaceuticals, biologics, or medical devices. It provides an overv

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List of Figures and Tables ix
Foreword xiii
Preface xv
Preface to Previous Edition xvii
Abbreviations xix
Part I Unique Challenges in Medical Product Development
Chapter 1 Healthcare in the United States 3
Chapter 2 It's Not Your Father's FDA: The "Modernization" of Medical Product Regulation 11
Chapter 3 Product Liability and Product Development 33
Part II Bringing a New Medical Product to Market
Chapter 4 Overview of the Approval Processes for Drugs, Biologics, and Medical Devices 43
Chapter 5 Designing-in Quality 55
Chapter 6 Designing-Out Disaster: Risk Analysis 63
Chapter 7 Recalls, Revocations, and Withdrawals 71
Chapter 8 Human Factors and the Nature of Relationships: Minimizing Medical Errors 77
Chapter 9 Is It Safe and Does It Work? Evaluating Safety and Efficacy in Clinical Trials 87
Chapter 10 How Much Is the Product Really Worth? Outcomes Research, Pharmacoeconomics, and Managed Care 101
Part III Product Development Planning
Chapter 11 Models and Metaphors: Product Development and the Product Development Organization 109
Chapter 12 Components of Product Development Planning: The Product Development Process 119
Chapter 13 Components of Product Development Planning: Development Portfolio Management 131
Chapter 14 Components of Product Development Planning: Technology Assessment 145
Chapter 15 Components of Product Development Planning: Technology Forecasting 153
Chapter 16 More for the Laundry List: Marketing, Patents, Budgets, Games, and Quality 163
Chapter 17 Where Do We Go from Here? 175
Endnotes 179
Glossary 183
Resources 187
Index 195

Title: Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices

Manufacturer:

ASQ Quality Press

Item Number: 9780873896139

Publication Date: December 2003

Number: 2

Product Description: Full Name: Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices; Short Name:Development of FDA-Regulated Medical Products

Universal Product Code (UPC): 9780873896139

WonderClub Stock Keeping Unit (WSKU): 9780873896139

Rating: 3/5 based on 2 Reviews

Image Location: https://wonderclub.com/images/covers/61/39/9780873896139.jpg

Category: Media >> Books

Weight: 0.200 kg (0.44 lbs)

Width: 6.000 cm (2.36 inches)

Heigh : 8.900 cm (3.50 inches)

Depth: 0.600 cm (0.24 inches)

Date Added: August 25, 2020, Added By: Ross

Date Last Edited: August 25, 2020, Edited By: Ross

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Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices, Many changes to the classification and regulation of prescription drugs, biologics, and medical devices have occurred since the previous edition of this book was published in 1997 under the title Product Development Planning for Health Care Products Regul, Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices

Add Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices, Many changes to the classification and regulation of prescription drugs, biologics, and medical devices have occurred since the previous edition of this book was published in 1997 under the title Product Development Planning for Health Care Products Regul, Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices to the inventory that you are selling on WonderClub

Add Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices, Many changes to the classification and regulation of prescription drugs, biologics, and medical devices have occurred since the previous edition of this book was published in 1997 under the title Product Development Planning for Health Care Products Regul, Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices to your collection on WonderClub

Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices Book

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	List of Figures and Tables	ix
	Foreword	xiii
	Preface	xv
	Preface to Previous Edition	xvii
	Abbreviations	xix
Part I	Unique Challenges in Medical Product Development
Chapter 1	Healthcare in the United States	3
Chapter 2	It's Not Your Father's FDA: The "Modernization" of Medical Product Regulation	11
Chapter 3	Product Liability and Product Development	33
Part II	Bringing a New Medical Product to Market
Chapter 4	Overview of the Approval Processes for Drugs, Biologics, and Medical Devices	43
Chapter 5	Designing-in Quality	55
Chapter 6	Designing-Out Disaster: Risk Analysis	63
Chapter 7	Recalls, Revocations, and Withdrawals	71
Chapter 8	Human Factors and the Nature of Relationships: Minimizing Medical Errors	77
Chapter 9	Is It Safe and Does It Work? Evaluating Safety and Efficacy in Clinical Trials	87
Chapter 10	How Much Is the Product Really Worth? Outcomes Research, Pharmacoeconomics, and Managed Care	101
Part III	Product Development Planning
Chapter 11	Models and Metaphors: Product Development and the Product Development Organization	109
Chapter 12	Components of Product Development Planning: The Product Development Process	119
Chapter 13	Components of Product Development Planning: Development Portfolio Management	131
Chapter 14	Components of Product Development Planning: Technology Assessment	145
Chapter 15	Components of Product Development Planning: Technology Forecasting	153
Chapter 16	More for the Laundry List: Marketing, Patents, Budgets, Games, and Quality	163
Chapter 17	Where Do We Go from Here?	175
	Endnotes	179
	Glossary	183
	Resources	187
	Index	195