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

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

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

ID: POP-226

Features:

Pages: 58

Published: Pre-2019

Delivery Format: Shipped

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