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

ISBN-10: 0873896130
ISBN-13: 9780873896139
Edition: 2nd 2003
Authors: Elaine Whitmore
List price: $40.00 Buy it from $4.89
30 day, 100% satisfaction guarantee

If an item you ordered from TextbookRush does not meet your expectations due to an error on our part, simply fill out a return request and then return it by mail within 30 days of ordering it for a full refund of item cost.

Learn more about our returns policy

Used Starting from $29.02
what's this?
Rush Rewards U
Members Receive:
coins
coins
You have reached 400 XP and carrot coins. That is the daily max!
You could win $10,000

Get an entry for every item you buy, rent, or sell.

Study Briefs

Limited time offer: Get the first one free! (?)

All the information you need in one place! Each Study Brief is a summary of one specific subject; facts, figures, and explanations to help you learn faster.

Add to cart
Study Briefs
Medical Terminology Online content $4.95 $1.99
Add to cart
Study Briefs
Medical Math Online content $4.95 $1.99
Add to cart
Study Briefs
Business Ethics Online content $4.95 $1.99

Customers also bought

Loading
Loading
Loading
Loading
Loading
Loading
Loading
Loading
Loading
Loading

Book details

List price: $40.00
Edition: 2nd
Copyright year: 2003
Publisher: ASQ Quality Press
Binding: Hardcover
Pages: 224
Size: 6.00" wide x 9.00" long x 0.75" tall
Weight: 1.320
Language: English

List of Figures and Tables
Foreword
Preface
Preface to Previous Edition
Abbreviations
Unique Challenges in Medical Product Development
Healthcare in the United States
It's Not Your Father's FDA: The "Modernization" of Medical Product Regulation
Product Liability and Product Development
Bringing a New Medical Product to Market
Overview of the Approval Processes for Drugs, Biologics, and Medical Devices
Designing-in Quality
Designing-Out Disaster: Risk Analysis
Recalls, Revocations, and Withdrawals
Human Factors and the Nature of Relationships: Minimizing Medical Errors
Is It Safe and Does It Work? Evaluating Safety and Efficacy in Clinical Trials
How Much Is the Product Really Worth? Outcomes Research, Pharmacoeconomics, and Managed Care
Product Development Planning
Models and Metaphors: Product Development and the Product Development Organization
Components of Product Development Planning: The Product Development Process
Components of Product Development Planning: Development Portfolio Management
Components of Product Development Planning: Technology Assessment
Components of Product Development Planning: Technology Forecasting
More for the Laundry List: Marketing, Patents, Budgets, Games, and Quality
Where Do We Go from Here?
Endnotes
Glossary
Resources
Index

×
Free shipping on orders over $35*

*A minimum purchase of $35 is required. Shipping is provided via FedEx SmartPost® and FedEx Express Saver®. Average delivery time is 1 – 5 business days, but is not guaranteed in that timeframe. Also allow 1 - 2 days for processing. Free shipping is eligible only in the continental United States and excludes Hawaii, Alaska and Puerto Rico. FedEx service marks used by permission."Marketplace" orders are not eligible for free or discounted shipping.

Learn more about the TextbookRush Marketplace.

×