ATU Sligo /ATU St Angela's

go

Amazon cover image
Image from Amazon.com

Development of FDA-regulated medical products : prescription drugs, biologics, and medical devices /

By: Whitmore, Elaine.
Contributor(s): Food and Drugs Administration [FDA].
Publisher: Milwaukee, Wis. : ASQ Quality Press, 2004Edition: 2nd ed.Description: xx, 202 p. : ill. ; 23 cm.Content type: text Media type: unmediated Carrier type: volumeISBN: 0873896130(hbk. : alk. paper); 9780873896139; 9780873896139(hbk. : alk. paper).Subject(s): United States. Food and Drug Administration | Drug and Narcotic Control -- legislation & jurisprudence -- United States | Drug approval -- United States | Biological Products -- legislation & jurisprudence -- United States | New products -- Standards -- United StatesDDC classification: 615.19
Contents:
List of figures and tables -- Foreword -- Preface -- Preface to previous edition -- Abbreviations -- Part I : unique challenges in medical product development. Chapter 1 : healthcare in the United States. Chapter 2 : it's not your father's FDA : the "modernization" of medical product regulation. Chapter 3 : product liability and product development -- Part II : bringing a new medical product to market. Chapter 4 : overview of the approval processes for drugs, biologics, and medical devices. Chapter 5 : designing-in quality. Chapter 6 : designing-out disaster : risk analysis. Chapter 7 : recalls, revocations, and withdrawals. Chapter 8 : human factors and the nature of relationships : minimizing medical errors. Chapter 9 : is it safe and does it work? Evaluating safety and efficacy in clinical trials. Chapter 10 : how much is the product really worth? Outcomes research, pharmacoeconomics, and managed care -- Part III : product development planning. Chapter 11 : models and metaphors : product development and the product development organization. Chapter 12 : components of product development planning : the product development process. Chapter 13 : components of product development planning : development portfolio management. Chapter 14 : components of product development planning : technology assessment. Chapter 15 : components of product development planning : technology forecasting. Chapter 16 : more for the laundry list : marketing, patents, budgets, games, and quality. Chapter 17 : where do we go from here? -- Endnotes -- Glossary -- Resources -- Index.
Summary: Previously published under the title: Product development planning for health care products regulated by the FDA.
Star ratings
    Average rating: 0.0 (0 votes)
Holdings
Item type Current library Call number Copy number Status Date due Barcode Item holds
Standard Loan Standard Loan ATU Sligo Yeats Library Main Lending Collection 615.19 WHI (Browse shelf(Opens below)) 1 Available 0092715
Standard Loan Standard Loan ATU Sligo Yeats Library Main Lending Collection 615.19 WHI (Browse shelf(Opens below)) 2 Available 0092716
Standard Loan Standard Loan ATU Sligo Yeats Library Main Lending Collection 615.19 WHI (Browse shelf(Opens below)) 3 Available 0092713
Standard Loan Standard Loan ATU Sligo Yeats Library Main Lending Collection 615.19 WHI (Browse shelf(Opens below)) 4 Available 0092714
Standard Loan Standard Loan ATU Sligo Yeats Library Main Lending Collection 615.19 WHI (Browse shelf(Opens below)) 5 Available 0092712
Total holds: 0

Includes bibliographical references and index.

List of figures and tables -- Foreword -- Preface -- Preface to previous edition -- Abbreviations -- Part I : unique challenges in medical product development. Chapter 1 : healthcare in the United States. Chapter 2 : it's not your father's FDA : the "modernization" of medical product regulation. Chapter 3 : product liability and product development -- Part II : bringing a new medical product to market. Chapter 4 : overview of the approval processes for drugs, biologics, and medical devices. Chapter 5 : designing-in quality. Chapter 6 : designing-out disaster : risk analysis. Chapter 7 : recalls, revocations, and withdrawals. Chapter 8 : human factors and the nature of relationships : minimizing medical errors. Chapter 9 : is it safe and does it work? Evaluating safety and efficacy in clinical trials. Chapter 10 : how much is the product really worth? Outcomes research, pharmacoeconomics, and managed care -- Part III : product development planning. Chapter 11 : models and metaphors : product development and the product development organization. Chapter 12 : components of product development planning : the product development process. Chapter 13 : components of product development planning : development portfolio management. Chapter 14 : components of product development planning : technology assessment. Chapter 15 : components of product development planning : technology forecasting. Chapter 16 : more for the laundry list : marketing, patents, budgets, games, and quality. Chapter 17 : where do we go from here? -- Endnotes -- Glossary -- Resources -- Index.

Previously published under the title: Product development planning for health care products regulated by the FDA.

Share