By Margaret B. Liu, Kate Davis(auth.)
Chapter 1 classes from a Horse Named Jim and different occasions in background Affecting the legislation of medical study (pages 1–11):
Chapter 2 the method: constructing New medicinal drugs, Biologics, and units (pages 13–48):
Chapter three solid medical perform and the rules (pages 49–72):
Chapter four trained Consent and the laws (pages 73–100):
Chapter five Institutional evaluate forums (pages 101–121):
Chapter 6 adversarial occasions and Unanticipated difficulties concerning hazards to topics or Others (pages 123–139):
Chapter 7 tracking, Audits, and Inspections (pages 141–162):
Chapter eight The significant Investigator, the medical examine Coordinator, and the examine website (pages 163–176):
Chapter nine The Protocol (pages 177–198):
Chapter 10 learn Feasibility: Reviewing a particular Protocol (pages 199–212):
Chapter eleven learn actions (pages 213–244):
Chapter 12 research Documents/Essential records (pages 245–269):
Chapter thirteen administration of research medicinal drugs, Biologics, and units (pages 271–279):
Chapter 14 coping with medical Trial information (pages 281–311):
Chapter 15 international overall healthiness and foreign Trials (pages 313–324):
Read Online or Download A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition PDF
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Additional info for A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition
In this way, researchers can gather data on the disease course and treatment in people outside of the clinical trial and compare them with findings from subjects participating in the study. qxd 11/16/09 15:17 Page 21 New Drug Application (NDA) to the FDA. The NDA contains extensive data on the test product, results and safety data from the clinical trials conducted, and may include copies of individual subject data forms. Once the FDA receives an NDA, it is distributed to the group of FDA reviewers responsible for the drug or biologics classification.
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Published 2010 by Blackwell Publishing A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition Margaret B. Liu and Kate Davis © 2010 by Duke Clinical Research Institute. qxd 11/16/09 15:17 Page 14 The process of developing new drugs is expensive and lengthy, requiring an average of ten years or longer to move a product from pre-clinical studies to marketing approval; the costs can range up to a billion dollars. Many experimental compounds never make it out of the laboratory; those that do move out of the laboratory often fail testing in animal models; and still others that reach clinical trials in humans may demonstrate toxicity or a lack of efficacy.
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