Pharmaceutical economics and policy 1st Edition by Stuart Schweitzer 0190293796 9780190293796

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ISBN-10 :  0190293796 

ISBN-13 :  9780190293796

Author:   Stuart O. Schweitzer 

The pharmaceutical industry is praised as a world leader in high technology innovation and the creator of products that increase both longevity and quality of life for people throughout the world. At the same time, the industry is also criticized for its marketing and pricing practices and for its apparent anticompetitive responses to generic competition. Even its research and development priorities are criticized as being too closely driven by the goal of maximizing shareholder value, rather than the health of the public. Unfortunately, many of the critics of the industry fail to understand the complexities of the industry and its role in the nations healthcare system. This book uses the tools of economic analysis to explore the conflicting priorities and aims of the pharmaceutical industry, from both an American and worldwide perspective.This is the second edition of a uniquely comprehensive and balanced discussion of pharmaceutical policy issues. All the chapters of the former edition have been fully re-written and extensively updated.In addition, the book includes six new chapters on emerging topics such as the broadened role of FDA regulations and the increasing diversity of the industry. An entire chapter is devoted to the biotechnology industry and one to alternative medicines, often called “nutraceuticals.” Another new chapter discusses segments of the industry that specialize in particular activities including generic drugs and drug delivery systems. The recent controversial expansion of Medicare to cover outpatient drugs is discussed in depth. The introduction is also updated to address the volatile pace of pharmaceutical innovation and how the pharmaceutical industry has responded to the emergence of managed care.

Pharmaceutical economics and policy 1st Table of contents:

Part I. The Industry
1 The Pharmaceutical Industry
Pharmaceutical Research and Development
The Competitive Structure of the Pharmaceutical Industry
Pharmaceutical Research and Development and Prices
The Pharmaceutical Research Process
Product Liability
Conclusions
2 The Biotechnology Industry
Background
Product Development in the Biotechnology Industry
The Natural History of Biotechnology Firms
Case Studies of Alliances
Regulation
Case Studies of Biotechnology Firm Growth
Conclusions
3 Other Firms in the Pharmaceutical Industry
Generic Drugs and Their Manufacturers
Outsourcing Firms
Conclusions
4 Marketing Pharmaceuticals
Size of Marketing Effort
Does It Work?
Types of Promotion
Disguising Marketing as Research
Marketing in an Era of Managed Care
Pharmacy Benefit Managers
Direct-to-Consumer Advertising
Over-the-Counter Drugs
Joint Marketing
Disease Management
Roles of the U.S. Food and Drug Administration in Marketing
False and Misleading Claims
Part II. The Consumer
5 The Demand for Pharmaceuticals
How Is Demand Determined?
The Changing Structure of the Pharmaceutical Market
Conclusions
Part III. The Market
6 Pharmaceutical Prices
The Problem of Pharmaceutical Prices
Pharmaceutical Prices over Time
Measuring Drug Prices
How Are Drug Prices Determined?
Cost Structure of Pharmaceutical Firms
Is the Pharmaceutical Industry Monopolistic?
How Drug Quality Influences Price
7 The Worldwide Market for Pharmaceuticals
Geographic Patterns of Pharmaceutical Production and Sales
Pharmaceutical Research and Development: An International View
Does Government Drug Price Setting Influence R&D?
Worldwide Manufacturing and Sales
Access to Appropriate Drugs in Developing Countries
Effect of the World Trade Organization Treaty
8 Pricing Pharmaceuticals in a World Environment
Why Do Drug Prices Vary Across Country?
Comparisons of International Drug Prices
How Do We Measure Drug Prices across Countries?
Why Drug Price Differences Persist
Policy Implications
9 The Timing of Drug Approvals in the United States and Abroad
The Timing of Pharmaceutical Approvals and Health Policy
The Drug Approval Process in the United States
Recent Initiatives to Expedite Drug Approvals
Is There a U.S. Drug Lag?
Part IV. Intervention in the Pharmaceutical Market: Public and Private
10 Pharmaceutical Regulation and Cost Containment by the Public Sector
Evolution of the U.S. Food and Drug Administration
Medicaid
State Cost-Containment Efforts
Medicare
11 Regulation by the Private Sector
Cost-Containment Mechanisms
Cost Containment in Managed Care
12 Pharmaceutical Regulation in Europe
The Pharmaceutical Industry in Europe
History of Regulation in Europe
Move Toward a Single Market
Structure and Role of the European Medicines Evaluation Agency
Drug Review under the European Medicines Evaluation Agency
Current Regulatory Structure
The Centralized Procedure for Marketing Authorization
The Mutual-Recognition Procedure
Performance of Europe’s Centralized Drug Approval
Rules on Labeling of Medicinal Products
Advertising Regulations
Pharmacovigilance
Generic Drugs
13 Patent Protection
Patent Law
Patentability and Patent Categories
How Are Patents Obtained?
What Protection Does a Patent Confer?
Duration of Patent Protection
Infringement of Patents
International Patent Treaties
Patent Procedures under International Conventions
Shortcomings of the Patent System
Patents and Societal Choice
Social Benefits of the Patent System
14 Evaluating New Drugs
Optimizing Production of Health
Cost-Benefit Analysis
Cost-Effectiveness Analysis
Cost-Utility Analysis
Policy Applications
Interpretation and Misinterpretation of Cost-Effectiveness Studies
15 Complementary and Alternative Medicines
Who Uses Complementary and Alternative Medicines?
Manufacturers and Distributors of Complementary and Alternative Medicines
Dietary Supplements
Food Additives
Medical Foods
Concluding Remarks on Complementary and Alternative Medicines
16 Pharmaceuticals and Health Policy: A Look Ahead
Structure of the Pharmaceutical Industry
Health System Reform
Drug Prices
Drug Imports
Patent Protection
Drug Approvals
Managed Care and Restricted Access to Pharmaceuticals
The U.S. Food and Drug Administration
Genetically Targeted Drugs

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