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Principles and Practice of Pharmaceutical Medicine

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ISBN-10: 1405194723

ISBN-13: 9781405194723

Edition: 3rd 2011

Authors: Lionel D. Edwards, Anthony W. Fox, Peter D. Stonier

List price: $241.95
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Book details

List price: $241.95
Edition: 3rd
Copyright year: 2011
Publisher: John Wiley & Sons, Limited
Publication date: 12/3/2010
Binding: Hardcover
Pages: 816
Size: 7.30" wide x 9.90" long x 2.00" tall
Weight: 3.652
Language: English

#60;b#62;Lionel D Edwards#60;/b#62; MB, BS, LRCP, MRCS, DipRCOG, FFPM, is Senior Director of Medical Affairs for Novartis USA, and President of Pharma Pro Plus Inc., a drug development consulting company. Dr. Edwards has been involved in all aspects of clinical trials for over 33 years on many different research drug and devices in 10 therapeutic areas. Dr. Edwards is a Fellow of the Faculty of Pharmaceutical Medicine and an Adjunct Professor at Temple University Graduate School of Pharmacology. He has taught for the Pharmaceutical Education & Research Institute for over 12 years and was on the teaching faculty of the National Association of Physicians. He is a founder member of the…    

#60;b#62;Lionel D Edwards#60;/b#62; MB, BS, LRCP, MRCS, DipRCOG, FFPM, is Senior Director of Medical Affairs for Novartis USA, and President of Pharma Pro Plus Inc., a drug development consulting company. Dr. Edwards has been involved in all aspects of clinical trials for over 33 years on many different research drug and devices in 10 therapeutic areas. Dr. Edwards is a Fellow of the Faculty of Pharmaceutical Medicine and an Adjunct Professor at Temple University Graduate School of Pharmacology. He has taught for the Pharmaceutical Education & Research Institute for over 12 years and was on the teaching faculty of the National Association of Physicians. He is a founder member of the…    

Overview of Pharmaceutical Medicine
The Practice and Practitioners of Pharmaceutical Medicine
Pharmaceutical Medicine as a Medical Specialty
Clinical Research Education and Training for Biopharmaceutical Staff
Drug Discovery and Development
Drug Discovery: Design and Development
Translational Medicine, Pharmaceutical Physicians, Patients, and Payers
Pharmaceutics
Nonclinical Toxicology
Informed Consent
Phase I: The First Opportunity for Extrapolation from Animal Data to Human Exposure
Phase II and Phase III Clinical Studies
Phase IV Drug Development: Post-marketing Studies
Site Management
Good Clinical Practices
Quality Assurance, Quality Control and Audit
The Unique Role of Over-the-Counter Medicine
Special Populations and Required Special Studies
Drug Research in Older Patients
Drug Development Research in Women
Clinical Research in Children
Racial and Ethnic Issues in Drug Regulation
Special populations: Hepatic and Renal Failure
Drug Interactions
Orphan Drugs
QT Interval Prolongation and Drug Development
Applied Aspects
Biotechnology Products and Their Development
Health Economics
Pharmacoeconomics: Economic and Humanistic Outcomes
Pharmacoepidemiology and the Pharmaceutical Physician
Statistical Principles and Application in Biopharmaceutical Research
Data Management
Patient Compliance: Pharmionics, A New Discipline
Monitoring Drug Concentrations in Clinical Practice
Generics
Complementary Medicines
Drug Regulation
United States Regulations
Special US Regulatory Procedures: Emergency and "Compassionate" INDs and Accelerated Product Approvals
The Development of Human Medicines Control in Europe from Classical Times to the 21st Century
Medicines Regulation in the European Union
Japanese Regulations
Drug Registration and Pricing in the Middle East
China's Regulated Pharmaceutical Market
India's New Era in Pharmaceuticals
Medical Services
Medical Affairs
Drug Labeling
Data Mining
Risk Management in Product Approval and Marketing
Publishing Clinical Studies
Organizing and Planning Local, Regional, National, and International Meetings and Conferences
When Things Go Wrong: Drug Withdrawals from the Market
International Trials: Successful Planning and Conduct
Legal and Ethical Aspects of Pharmaceutical Medicine
Introduction to Bioethics for Pharmaceutical Professionals
Pharmaceutical Medicine and the Law
Fraud and Misconduct in Clinical Research
Business Aspects
The Multinational Corporations: Cultural Challenges, the Legal/Regulatory Framework and the Medico-commercial Environment
Advertising and Marketing
Pharmaceutical Product Liability
Patents
Outsourcing Clinical Drug Development Activities to Contract Research Organizations (CROs): Critical Success Factors
The Impact of Managed Care on the US Pharmaceutical Industry