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Products & Services

Product Commercialization Excellence: Preparation and Management of Fixed-dose Combination (FDC) Drug Products

ID: POP-226


Features:

3 Info Graphics

41 Data Graphics

150+ Metrics

5 Narratives

6 Best Practices


Pages: 58


Published: Pre-2013


Delivery Format: Shipped


 

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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919-403-0251

  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • VIEW TOC AND LIST OF EXHIBITS
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; Sanofi-aventis; Supernus; Bausch & Lomb; Bayer; Hoffman-LaRoche; Merck; Pfizer; 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


Sample List of Charts & Exhibits

Past, Present and Future Number of FDC Drugs in Development
  • Additive vs. Synergistic Effects
  • Bioequivalence vs. Clinical Evaluation (Preferences and reasons why)
  • Starting Development Prior vs. Post Patent Expiration
  • Use of External Consultants
  • Bioequivalence - Timeframe from Conception to Final Formulation Launch
  • Clinical Evaluation - Timeframe from Conception to Final Formulation Launch
  • Bioequivalence - Timeframe from Initiating Formulation Development to Final Formulation Launch
  • Clinical Evaluation - Timeframe from Initiating Formulation Development to Final Formulation Launch
  • Bioequivalence - Timeframe from Initiating Formulation Development to Prototype Completion Timeframe
  • Bioequivalence - Frequency of In-Vitro Work
  • Bioequivalence - In-Vitro Timeframe
  • Bioequivalence - Frequency of Animal PK Studies
  • Bioequivalence - Number of Animal PK Studies
  • Bioequivalence - Frequency of Human PK Studies
  • Bioequivalence - Number of Human PK Studies
  • Bioequivalence - Prototype Timeframe
  • Bioequivalence - Number of Prototypes
  • Clinical Evaluation - Timeframe from Initiating Formulation Development to Prototype Completion Timeframe
  • Clinical Evaluation - Frequency of In-Vitro Work
  • Clinical Evaluation - In-Vitro Timeframe
  • Clinical Evaluation - Frequency of In-Vivo Work
  • Clinical Evaluation - In-Vivo Timeframe
  • Clinical Evaluation - Prototype Timeframe
  • Clinical Evaluation - Number of Prototypes
  • Number of Drugs, FTEs and Timeframe to Reach First Pilot PK Study
  • Number of Drugs, FTEs and Timeframe to Reach Second Pilot PK Study
  • Number of Drugs, FTEs and Timeframe to Reach Pivotal BE Study
  • Number of FTEs in Analytical Development
  • Timeframe from Initiating Development Work to CTM Manufacturing for Class 1/2/4 drugs