Main description:

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. 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. Bringing together the latest information on drug development, the Second Edition contains: new material on international regulation and deregulation; venture capitalist investment; the IND process; informed consent changes in manufacturing and updated and extended coverage of a pediatric drug trial design; the advantages and disadvantages of orphan drug designation;s the maximization of package inserts for marketing post approval; and; safety surveillance withdrawals from the drug market.
"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.

Contents:

Current Challenges and Future Directions of Drug DevelopmentAllen Cato, Lynda Sutton, and Allen Cato IIIPreclinical Drug Discovery and DevelopmentDavid S. Duch and Robert M. FerrisThe IND Process for New Drug ProductsDavid M. CocchettoPerformance and Interpretation of Laboratory TestsW. Leigh Thompson, Rocco L. Brunelle, and Michael G. WilsonIssues in Endpoint SelectionKaren D. Weiss and Jay Philip SiegelDix, Cent, Mille: Proof of Principle with $10 Million, 100 Patients, and 1000 DaysW. Leigh ThompsonClinical Drug Trials in Pediatrics: Dilemmas of Clinical Drug Trials in Pediatric PopulationsAllen Cato and Myron B. PetersonElectronic Capture of Clinical Trial InformationDaniel C. Cato and David B. ThomasProviding Patient Access to Promising Investigational DrugsPeggy J. Berry and Allen CatoIssues in the Review of Clinical Drug Trials by IRBsDale H. CowanPersonal Care and Randomized Clinical Trials: Understanding the Ethical ConflictsPaul J. ReitemeierInformed Consent in Clinical Trials: Emerging IssuesCheryl K. Fiedler and H. Russell SearightOrphan Drug Development: David and GoliathAllen Cato, Susan L. Watts, Lynda Sutton, and Marlene E. HaffnerSingle-Event Adverse Drug Reactions: Tribulations in Ascribing CausalityNelson S. IreyHow to Deal with a Sudden, Unexpected Death in Clinical StudiesAllen Cato and Lynda SuttonClinical Trial Material-The Fuel for Clinical ResearchDavid F. BernsteinThe Role of Pharmacokinetics in Drug DevelopmentAllen Cato III and Richard GrannemanBuilding an NDA/BLADiana E. Fordyce and Angela CahillInternational Planning of Drug Clinical TrialsDavid L. HorwitzUncertainty in Drug Development: Approval Success Rates for New DrugsJoseph A. DiMasiContract Clinical Research: Value to In-House Drug DevelopmentF. Richard NicholPackage Inserts as Viewed by the Busy Private PractitionerJean M. FindlayNew Directions in Pharmaceutical Promotion: Regulatory Concerns and ContrivancesLouis A. Morris and Peter H. RheinsteinThe Campus Researcher and Industry: Issues of Intellectual Property and Technology TransferTodd S. KeillerAnatomy of Drug Withdrawals in the United StatesMarion J. FinkelAppendices: Routine Clinical Analyte Test ResultsIndex