Clinical Drug Trials and Tribulations, Second Edition, (Drugs and the Pharmaceutical Sciences)

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… · pediatric drug trial design · the advantages and disadvantages of orphan drug designations · the maximization of package inserts for marketing · post approval 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.

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—
• Pediatric Drug Trial Design
• The Advantages And Disadvantages Of Orphan Drug Designations
• The Maximization Of Package Inserts For Marketing
• Post Approval 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.

doody Review Services

reviewer:aryeh Hurwitz, M.d.(university Of Kansas School Of Medicine)
description:this Book Provides An Overview Of Clinical Trials In Drug Development. Among Topics Discussed Are Trial Design, Ethical And Regulatory Matters, And Practical Issues In Study Implementation. The First Edition Was Published In 1988.
purpose:the Authors Purposely Include Some How To Information, But Try To Focus On The Whys Behind Decisions At The Numerous Steps In Drug Development. These Are Worthy Objectives. Some Of The 25 Chapters Try To Cover So Much Material That They Become Too Superficial To Be Useful. In Some Of These Cases The References Are Not Current Enough To Compensate For This Defect. Other Chapters Are Quite Interesting And Provocative. Generally The Authors' Objectives Were Met.
audience:the Authors Intend This Book To Be Read By Neophytes In Clinical Drug Development As Well As By More Experienced Investigators. That's A Pretty Broad Audience. Nevertheless, The Book Does Succeed In Providing Useful And Interesting Material To Its Intended Audience. It Could Be Helpful For Introducing Beginners To Clinical Drug Trials, Although Some Missing Topics, Like Recruitment Of Subjects, Will Necessitate Reading Of Other Sources. Based On Their Experience In Drug Trials The Authors Are Qualified To Write This Book.
features:this Book Includes Chapters On Regulatory Issues, Ethics, Toxicity, And Data Management. Most Of These Chapters Provide A Reasonable Overview And Introduction, But Are Not Really Thorough Enough To Overcome The Need For Further Reading By Anyone Interested In A Specific Topic. This Limitation Makes It Essential To Have Current References For Each Chapter. Some Of The Chapters Have Essentially No References Within The Past Five Years, Including The Chapters On Pharmacokinetics (including Drug Metabolism) And Drug Withdrawals -- Areas Of Much Current Interest.
assessment:this Book Falls In The Middle Among The Leading Recent Books On Clinical Drug Trials. Of These, The Most Encyclopedic --and Expensive -- Single Volume Monograph Is Bert Spilker's guide To Clinical Trials (lippincott Williams & Wilkins, 1991). fundamentals Of Clinical Trials, 3rd Edition, By Friedman Et Al. (springer-verlag, 1998) Is The Least Expensive And Provides A Reasonable, Statistically-based Introduction And Overview Of Clinical Trial Methodology. clinical Trials: A Methodological Perspective By Piantadosi (john Wiley & Sons, 1997) Is Very Heavily Mathematical And Theoretical, And Is Therefore Not Suitable For Beginners. Fourteen Years Have Elapsed Between The First And Second Edition Of This Book. Although The References For Some Of The Chapters Are Not As Current As Would Be Desirable, There Is No Question That Much Of The Content Of The New Edition Is Updated.