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Principles and practice of pharmaceutical medicine /

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Bibliographic Details
Uniform Title:Principles and practice of pharmaceutical medicine (Online)
Other Authors: Fletcher, Andrew J.
Format: eBook
Language:English
Published: Chichester, West Sussex ; New York : Wiley, [2002]
Subjects:
Drug Industry > organization & administration.
Drug Evaluation.
Online Access:Principles and practice of pharmaceutical medicine (Online)
Table of Contents:
  • 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
  • Design and serendipity
  • Pharmaceutics
  • Non-clinical toxicology
  • Informed consent
  • Good clinical practices
  • Quality assurance, quality control and audi
  • Phase I : the first opportunity for extrapolation from animal data to human experience
  • Phase II and Phase III clinical studies
  • Phase IV development : post-marketing studies
  • Over-the counter medicines
  • Special populations
  • Biotechnology products and their development
  • Orphan drugs
  • Pharmacoeconomics : economic evaluation and humanistic outcomes
  • Pharmacoepidemiology and the pharmaceutical physician
  • Statistical principles and their application in bio-pharmaceutical research
  • Data management
  • Patient compliance
  • Complementary medicine
  • Drug registration : introduction
  • US regulation
  • Emergency and compassionate-use INDs and accelerated NDA and ANDA approvals - Procedures, benefits and pitfalls
  • Japanese regulations
  • EC regulations
  • International committee on harmonisation
  • Medical services
  • Advertising material
  • Drug labelling
  • Scientific 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 organisation : critical success factors
  • Third World
  • Financial aspects of clinical trials
  • The impact of managed care on the US pharmaceutical industry