Publisher's Synopsis
This is an international guide to all areas of drug development and medical aspects of marketing. Both the regulatory and scientific aspects of the speciality of pharmaceutical medicine have evolved rapidly in recent years and Principles and Practice of Pharmaceutical Medicine assesses the current status of the field as well as giving some prospectus of how things may develop in the future.
∗ provides a refresher for the expert and an essential foundation for the novice
∗ outlines an academic framework for good practice
This is an excellent source of information for all those practising pharmaceutical medicine – pharmaceutical physicians, regulatory physicians, clinical researchers, marketing executives, research nurses. It covers essential information for those studying for diplomas in pharmaceutical medicine and related fields and for specialists fulfilling requirements for continuing medical education.
Includes:
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
Pharmaceutics
Informed consent
Good Clinical Practices
Drug Registration
US Regulations
Japanese Regulations
Ethnic Issues in Drug Registration
Medical Services
Drug Surveillance
Publishing Clinical Trials
Legal and Ethical Aspects
Pharmaceutical product liability
Patents
Business Aspects
Financial Principles of clinical trials
Third World
Multinational Corporations
