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Principles and Practice of Pharmaceutical Medicine

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ISBN-10: 0471986550

ISBN-13: 9780471986553

Edition: 2000

Authors: Andrew Fletcher, Lionel Edwards, Anthony Fox, Peter D. Stonier

List price: $280.00
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Description:

Providing a treatment of pharmaceutical medicine from a primarily US perspective, this volume begins with a detailed overview of its origins, and goes on to examine current career opportunities, education and training.
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Book details

List price: $280.00
Copyright year: 2000
Publisher: John Wiley & Sons, Incorporated
Publication date: 9/9/2002
Binding: Hardcover
Pages: 556
Size: 8.00" wide x 10.00" long x 1.25" tall
Weight: 2.992
Language: English

About the Editors
List of Contributors
Preface
Overview of Pharmaceutical Medicine
Pharmaceutical Medicine as a Medical Speciality
What Pharmaceutical Medicine Is and Who Does It
Competency-based Training System for Clinical Research Staff
Drug Discovery and Development
Introduction
Drug Discovery: Design and Serendipity
Pharmaceutics
Non-clinical Toxicology
Informed Consent
Good Clinical Practices
Quality Assurance, Quality Control and Audit
Phase I: The First Opportunity for Extrapolation from Animal Data to Human Experience
Phase II and Phase III Clinical Studies
Phase IV Drug Development: Post-marketing Studies
Over-the-counter Medicines
Special Populations
Introduction
Drug Research in Older Patients
Drug Development Research in Women
Clinical Research in Children
Applied Aspects of Drug Development
Introduction
Biotechnology Products and Their Development
Orphan Drugs
Pharmacoeconomics: Economic and Humanistic Outcomes
Pharmacoepidemiology and the Pharmaceutical Physician
Statistical Principles and Their Application in Biopharmaceutical Research
Data Management
Patient Compliance
Complementary Medicines
Drug Registration
Introduction
United States Regulations
Emergency and Compassionate-use INDs and Accelerated NDA or ANDA Approvals--Procedures, Benefits and Pitfalls
Japanese Regulations
The Development of Human Medicines Control in Europe from Classical Times to the Year 2000
Ethnic Issues in Drug Registration
Medical Services
Introduction
An Introduction to Medical Affairs
Drug Labeling
Organizing and Planning Local, Regional, National and International Meetings and Conferences
Drug Surveillance
Disease Management--What Does It Mean?
Publishing Clinical Studies
Legal and Ethical Aspects
Introduction
Pharmaceutical Product Liability
Patents
Fraud and Misconduct in Clinical Research
Business Aspects
The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico-commercial Environment
Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs): Critical Success Factors
The Third World
Financial Aspects of Clinical Trials
The Impact of Managed Care on the US Pharmaceutical Industry
Useful Internet Links
Index