Clinical Drug Trials and Tribulations Revised and Expanded

<p>Aimed at those already involved in drug development or those considering entering the field Clinical Drug Trials and Tribulations Second Edition comprehensibly addresses the new day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies.<br><br>Addressing which decisions should be made during drug development this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management.<br><br>Bringing together the latest information on drug development the Second Edition contains:<br><br>new material on…</p><li>international regulation and deregulation <br> </li><li>venture capitalist investment <br> </li><li>the IND process <br> </li><li>informed consent <br> </li><li>changes in manufacturing<br>and updated and extended coverage of…<br> </li><li>pediatric drug trial design <br> </li><li>the advantages and disadvantages of orphan drug designations <br> </li><li>the maximization of package inserts for marketing <br> </li><li>post approval safety surveillance <br> </li><li>withdrawals from the drug market<br>Clinical Drug Trials and Tribulations Second Edition will prove an invaluable reference for pharmacologists pharmacists clinical chemists clinical coordinators clinical monitors government drug regulatory personnel and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.</li>