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Products & Services New Product Development Early stage commercialization

Benchmarking FDC Drug Development Programs

ID: 5013


Features:

3 Info Graphics

41 Data Graphics

150+ Metrics

5 Narratives

6 Best Practices


Pages/Slides: 59


Published: Pre-2014


Delivery Format: Online PDF Document


 

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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
  • SPECIAL OFFER
The objective of this benchmarking study was to better understand fixed-dose combination (containing two or more active pharmaceutical ingredients) product development strategies and timelines. The research explored a number of critical questions, including: whether organizations seek additive or synergistic FDC drugs; why companies chose either a bioequivalence or clinical evaluation approach; and whether organizations are using external consultants and why. Among the many benchmarks included in this study are timeframes for both bioequivalence and clinical evaluation development approaches and the number, types and frequency of tests required. Executives who are responsible for fixed-dose combination (FDC) drug development can use this data to assess the effectiveness and efficiency of their FDC drug product development programs.

Industries Profiled:
Pharmaceutical; Consumer Products; Manufacturing; Biotech; Diagnostic; Medical Device; Health Care


Companies Profiled:
Abbott Laboratories; Supernus; Bausch & Lomb; Bayer; Hoffman-LaRoche; Merck; Pfizer; Sanofi-aventis; Solvay Pharmaceuticals; Takeda Pharmaceuticals; UCB Pharma


Study Snapshot

This research was conducted on behalf of one of Best Practices, LLC's clients and was based on survey results from 15 participants from 11 companies. This study gives companies a landscape view of how other organizations are pursuing FDC Drug development.

Key topics include:
  • Bioequivalence Approach
  • Clinical Evaluation Approach
  • Lessons Learned
  • FTEs and Complexity

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.