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Products & Services Clinical Operations Outsourcing in Clinical Trial Management

Pharmaceutical Bioequivalence Studies: Measuring Cost, Quality and Productivity

ID: 5099


Features:

14 Info Graphics

26 Data Graphics

140+ Metrics


Pages/Slides: 49


Published: Pre-2013


Delivery Format: Online PDF Document


 

License Options:
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Single User: Authorizes use by the person who places the order or for whom the order was placed.

Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.

Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.




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  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • SPECIAL OFFER
The competitive marketplace that generics manufacturers work in requires the ability to quickly deliver new products while maintaining a low-cost operation capable of producing quality products. Best Practices, LLC developed this study to identify key cost, quality and productivity metrics for the critical bioequivalence studies that are required to bring a new generic drug to market.


Specifically, this study delivers outsourcing trends, geographic shifts and key performance metrics in the current generics marketplace. In addition, the study provides insights, best practices and lessons learned regarding bioequivalence studies.

Managers and executives at generics organizations who are responsible for overseeomg bioequivalence studies in support of an Abbreviated New Drug Application (ANDA) to the U.S. FDA can use this study to compare their key operational metrics with those of leading organizations in the generics industry.


Industries Profiled:
Pharmaceutical; Service; Research; Health Care; Manufacturing; Biotech


Companies Profiled:
Apotex; Clinigene; Dr Reddy's Laboratories; GeneraMedix; Merck; Lupin; Perrigo Company; Naari; Ranbaxy; ratiopharm; Sanofi-aventis; Roxane Laboratories; Teva Pharmaceutical Industries Ltd; Sun Pharmaceutical; Wockhardt; ZARS Pharma; Zentiva; Zydus Cadila


Study Snapshot

Qualitative and quantitative data for this study were collected through an online survey instrument. Participants in this benchmarking research included 20 executives at 18 leading generics companies. Most benchmark participants hold job titles at the director-level and above, and nearly half work in R&D organizations.

Key topics include:
  • Outsourcing Activities And Trends: Use Of CROs In Less Regulated Regions
  • Bioequivalence Volume And Cost Metrics
  • Bioequivalence Practices and Processes: Use of Pilot Studies, Power and E-submission
  • Clinical Quality Assurance Function: Dedicated CQA Prevalence & Structure
  • Best Practices
  • Pitfalls and Lessons Learned

Sample Key Finding

Activities Outsourced: The most frequently outsourced bioequivalence function is clinical activity. All of the benchmarked generics companies outsource clinical activities at least some of the time and 65% always do. Quality Assurance is the function least likely to be outsourced by participating companies. Half never outsource that function and another 5% rarely do.

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.