Read e-book online Global clinical trials : effective implementation and PDF

By Richard Chin, Menghis Bairu

ISBN-10: 0123815371

ISBN-13: 9780123815378

This booklet will discover the nice possibilities and demanding situations which exist in engaging in medical trials in constructing international locations. via exploring some of the rules particular to the most important avid gamers and delivering perception into the logistical demanding situations together with language obstacles, this ebook offers a operating instrument for scientific researchers and directors to navigate the intricacies of medical trials in constructing international locations. vital subject matters akin to moral concerns should be dealt with very rigorously to spotlight the numerous transformations of undertaking this paintings in quite a few jurisdictions. total, it is going to current a transparent and complete consultant to the ins-and-outs of scientific trials in a variety of international locations to help in layout, improvement, and effectiveness of those trials.

  • Contributors comprise high-profile, revered figures who've prepared the ground for scientific trials in constructing countries
  • Provides hands-on instruments for regulatory and felony specifications and qualification, layout, administration, and reporting
  • Case reports define successes, disasters, classes realized and clients for destiny collaboration
  • Includes country-specific instructions for the main applied countries
  • Foreword by way of David Feigel, former Head of CDRH at FDA

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Example text

Research essentially follows the money focusing on degenerative diseases – arthritis, obesity, Bioethical Considerations in Global Clinical Trials 23 cardiovascular disease – illnesses of the developed world. Only 1 percent of the drugs developed in the past 25 years have targeted tropical diseases, an ethical doublestandard that recalls the inequities of the colonial era. 1. Responsibility to Patients The health of my patient shall be my first consideration [12]. World Medical Association Declaration of Geneva (1948) What follows is a compilation of the principles, challenges and responsibilities inherent in human biomedical research; a list of best practices drawn from the Declaration of Helsinki and other standards.

Some drug–drug interaction and food–drug interaction data may be required as well, particularly if certain drugs and food differ significantly between two populations. In many cases, there is sufficient evidence about the pharmacokinetics or pharmacodynamics endpoint and their relationships to clinical data that 12 Richard Chin and Menghis Bairu demonstrating equivalence at the pharmacokinetics or pharmacodynamics level may be sufficient. Occasionally, there may be a need for additional clinical data.

As of 2010, 42 proprietary and 61 generic medicines had undergone the prequalification process successfully. Many of the drugs are for diseases with an extremely high burden of illness in developing countries, such as drugs for HIV, malaria, and tuberculosis. The stated criteria for assessment of the drugs are “the same as those used by the European Agency for the Evaluation of Medicinal Products (EMEA) and the USA Food and Drug Administration (FDA). In other words, the prequalification assessment team evaluates the required data, including in vivo bioequivalence tests carried out by the manufacturers” [5].

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Global clinical trials : effective implementation and management by Richard Chin, Menghis Bairu


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