By Margaret B. Liu, Kate Davis(auth.)
Chapter 1 classes from a Horse Named Jim and different occasions in historical past Affecting the law of medical learn (pages 1–11):
Chapter 2 the method: constructing New medicinal drugs, Biologics, and units (pages 13–48):
Chapter three reliable medical perform and the rules (pages 49–72):
Chapter four knowledgeable Consent and the laws (pages 73–100):
Chapter five Institutional evaluate forums (pages 101–121):
Chapter 6 hostile occasions and Unanticipated difficulties concerning dangers to matters or Others (pages 123–139):
Chapter 7 tracking, Audits, and Inspections (pages 141–162):
Chapter eight The vital Investigator, the scientific examine Coordinator, and the learn website (pages 163–176):
Chapter nine The Protocol (pages 177–198):
Chapter 10 research Feasibility: Reviewing a particular Protocol (pages 199–212):
Chapter eleven research actions (pages 213–244):
Chapter 12 learn Documents/Essential files (pages 245–269):
Chapter thirteen administration of research medications, Biologics, and units (pages 271–279):
Chapter 14 dealing with scientific Trial info (pages 281–311):
Chapter 15 worldwide well-being and overseas Trials (pages 313–324):
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Extra info for A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition
N Table of contents. n An introductory statement and general description of the plan for studying the drug or biologic. n An Investigator’s Brochure containing information pertaining to the investigational drug formulation, pharmacokinetics, toxicology, safety and effectiveness from previous studies, and potential anticipated risks and side effects based on prior experience. n A protocol for each planned study. n Names of investigators, facilities, and Institutional Review Boards (IRBs) (or completed Forms FDA 1572) where studies will be conducted.
Recognizing these limitations, Congress passed the 1938 Food, Drug & Cosmetic Act, which required premarket approval of new drugs, giving the newly-formed FDA authority to review drug safety before marketing. In 1962, in response to the scope of the thalidomide tragedy, Congress passed the Kefauver-Harris Amendment to the Food, Drug & Cosmetic Act requiring proof of drug effectiveness and greater proof of safety before marketing. qxd 15:17 Page 15 New Drug Development Timeline 2. 1 11/16/09 Pre-Clinical Studies When new compounds show potential in laboratory tests, studies are designed to evaluate these compounds for pharmacologic use.
Biologics, as their name suggests, are generally derived from living material – human, animal, or microorganism. Section 351 of the Public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product . . ” Considered a subset of drugs, biological products are regulated under provisions of the Food, Drug, and Cosmetic Act. Licensing of biologic products is very similar to the process for approving new drugs.
A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition by Margaret B. Liu, Kate Davis(auth.)