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Ethical Issues in Drug Development:A Deterrent To Fraud and other Malfeasance
Drug and Market Development Publishing, Jan 2005, Pages: 54


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This Report presents an unbiased reflection of the current state of knowledge in several controversial, cutting edge areas of medical science and research. Its goal is to provide the facts necessary for professionals to reach their own conclusions in regard to ethical issues in drug development.

This Report reviews current thinking about when life actually begins. Practical issues relating to the use of stem cells are overviewed as well as the topics associated with clinical research in children. The Report also deals with the appropriateness of withholding treatment in the case of terminally ill patients. In addition, it profiles the unfortunate occurrence of fraud in clinical research and the ways in which those involved in clinical research can be prepared to prevent its recurrence.

The author of this title, Dr Robin J Harman, is a registered pharmacist who works as a pharmaceutical and regulatory consultant. He has worked within the regulatory affairs sector of both the pharmaceutical and medical device industries for the past 15 years. He has carried out many wide-ranging projects for both companies and regulatory authorities, and regularly meets with senior staff in companies and regulatory authorities to interview them for regulatory publications. In 1990, he was the first Editor of The Regulatory Affairs Journal, establishing the journal as a leading authoritative source of regulatory intelligence worldwide during his 8 years tenure. He was also the first Editor of The Regulatory Affairs Journal (Devices). He has published widely on all aspects of the control and development of medicinal products and medical devices, and has also written and edited four general pharmacy textbooks published by the Pharmaceutical Press, the publishing division of the Royal Pharmaceutical Society of Great Britain.





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