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Your risk assessment team can learn today's best strategies for designing and coordinating safety studies that deliver reliable data efficiently. In this book, two world-renowned authorities connect you with practical tips from real-world experts and former FDA officials. Reaching beyond what's available in regulations or guidelines, here's the know-how to prevent delays and "do-overs" and give your program the absolute best chance for success. Real-world strategies for designing, sequencing and coordinating studies that deliver reliable data for making initial assessments of new drug safety Practical considerations for minimizing cost, regulatory delays and the use of animals to make the smartest go/no-go decisions faster Case studies for the risk assessment studies conducted for Ranolazine and Fluoroquinolone William K. Sietsema, PhD, is a noted author and an inventor on four patents. His 22 years of experience in the pharmaceutical industry include playing a pivotal role in the rapid development of Pharmacia's Celebrex, which transitioned from the beginning of Phase II to NDA approval in less than three years. He is currently vice president of U.S. Regulatory Consulting and Submissions at Kendle, and adjunct professor of pharmaceutical sciences at the University of Cincinnati, College of Pharmacy. Richard Schwen, PhD, DABT, RAC, is certified in both toxicology and regulatory affairs and currently serves as vice president of Safety and Regulatory Affairs for Cincinnati-based Strategic Regulatory Consulting. Prior to this, he held senior regulatory affairs positions with Kendle International and Parexel International and spent 23 years with Procter and Gamble's drug research organization where he gained hands-on experience with drug discovery (four patents), toxicology and regulatory affairs.
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