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The Largest Compendium of Drug Approval Performance Metrics Ever Compiled!

Finally a comprehensive source for the very latest performance metrics and trend analysis on every key aspect of the new drug approval process--The US Drug Approval Trends and Yearbook 2008/2009!

Building on last year's widely read edition, the new 2008/2009 edition examines hundreds of key trends and metrics to provide industry with all-new benchmarks and metrics on which to assess their own performance, to plan their own R&D projects, and to assess the various drug approval options and strategies available to them.

The US Drug Approval Trends and Yearbook 2008/2009 provides an unprecedented number of in-depth analyses and benchmarks, including the following:
  • NDA and NME first-cycle success rates, review outcomes, and trends

  • Complete review and approval profiles for each NME and NDA, including cycles to approval, review times, and review outcomes

  • Analysis of drug review times, review cycle outcomes and success rates by therapeutic category and standard vs. priority classification

  • NDA and NME cycles to approval and review times through mid-2006

  • The impact of priority review, fast track, accelerated approval, orphan drug status and related programs on review times and review outcomes

  • Review outcomes, review times, and success rates for other key new drug submissions, including NDA resubmissions, efficacy supplements, and manufacturing supplements
Based on data compiled through internal studies, Freedom of Information requests to the FDA, and other public and private sources, our proprietary analyses will provide you with unique insights, benchmarks, and performance metrics in areas critical to the success of your R&D projects. We guarantee it!

The US Drug Approval Trends and Yearbook 2008/2009
Approx. 200 pages. Softcover. Price: $295+ Shipping.

Shipping July 2008!



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Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

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PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)