Navigation Links
New Study Provides Benchmarks for Fixed-Dose Combination (FDC) Drug Development

CHAPEL HILL, N.C., Nov. 4 /PRNewswire/ -- As biopharmaceutical companies focus on line extensions and new product development opportunities, fixed-dose combination (FDC) products have become an increasingly important segment of the market. In an effort to better understand the development strategies and issues for new FDC products, a recent study was conducted by Best Practices, LLC, with insights available in the newly published report, "Product Commercialization Excellence: Preparation and Management of Fixed-dose Combination (FDC) Drug Products." 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 for what purposes.

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.

To view the study abstract or complimentary summary of the full report "Product Commercialization Excellence: Preparation and Management of Fixed-dose Combination (FDC) Drug Products," click on the following link .

In a benchmarking study that included such influential companies as Abbott, Bayer, Roche, Merck, Pfizer, and Sanofi-Aventis, many key topics were covered, including:
-- Bioequivalence Approach

-- Clinical Evaluation Approach

-- Lessons Learned

-- FTEs and Complexity

Among the key metrics gathered in this report are:

-- 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


-- Bioequivalence - Timeframe from Initiating Formulation Development to

Final Formulation Launch

-- Clinical Evaluation - Timeframe from Initiating Formulation Development

to Final Formulation Launch

-- Bioequivalence - Multiple Metrics

-- Clinical Evaluation - Multiple Metrics

-- Number of Drugs, FTEs and Timeframe to Reach First/Second Pilot PK


-- 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

For more information on this report, contact Robert Naylor at or (919) 767-9244. To access the full report or download a complimentary copy of the report summary, go to .


Best Practices, LLC, conducts work based on the simple yet profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies. For more than 15 years, our highly credentialed research staff has conducted primary research exclusively for our Fortune 500 client base.

SOURCE Best Practices, LLC
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Penn study finds pro-death proteins required to regulate healthy immune function
2. New study shows promise in reducing surgical risks associated with surgical bleeding
3. Study, meta-analysis examine factors associated with death from heatstroke
4. Study suggests loss of 2 types of neurons -- not just 1 -- triggers Parkinsons symptoms
5. Study says COPD testing is not measuring up
6. Preclinical study suggests organ-transplant drug may aid in lupus fight
7. Ability to cope with stress can increase good cholesterol in older white men, study finds
8. High alcohol consumption increases stroke risk, Tulane study says
9. Mailman School of Public Health study examines link between racial discrimination and substance use
10. Pitt study finds inequality in tobacco advertising
11. Stanford study highlights cost-effective method of lowering heart disease risks
Post Your Comments:
(Date:11/24/2015)... ... November 24, 2015 , ... It takes only three to five ... is critical that the first impression be positive and reflects business values. If a ... buy anything or want to return. They will also share their thoughts about a ...
(Date:11/24/2015)... ... November 24, 2015 , ... United Benefit ... welcome Winter-Dent & Company as its newest Partner Firm. Based in Jefferson City, ... client's most trusted advisor regardless of whether that client is a business, a ...
(Date:11/24/2015)... ... November 24, 2015 , ... Serenity Point Rehabilitation, a holistic treatment center ... interviews with some of the staff members at their recovery center. The videos highlight ... well as some of the things that make their recovery program so unique. , ...
(Date:11/24/2015)... , ... November 24, 2015 , ... ... has been designated an Aetna Institute of Quality® Bariatric Surgery Facility for treating ... quality and cost of health care services available to its members to help ...
(Date:11/24/2015)... ... November 24, 2015 , ... ... Healthy Aging Program have announced their endorsement of the Medical Fitness Network ... Fitness is proud to have the MFN as one of our endorsed organizations,” ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... NEWS, Va. , Nov. 24, 2015  DILON ... they have signed an agreement for DILON to distribute ... geographies across the globe. The signing of this distribution agreement ... Discovery NM750b Molecular Breast Imaging system and is considered ... to provide better healthcare solutions for clinicians and their ...
(Date:11/24/2015)... , Nov. 24, 2015 Avery Biomedical ... is pleased to announce the appointment of Anders ... Dr. Jonzon ... cardiology at Children,s Hospital, Uppsala University, Uppsala and Children,s ... 1984-1986, he was a fellow at the Cardiovascular Institute ...
(Date:11/24/2015)... LAUSANNE and BERN, Switzerland ... SA, the ARTORG Center for Biomedical Engineering Research of ... and the Division of Endocrinology, Diabetes and Clinical Nutrition ... announce the start of an exclusive collaboration to develop ... control algorithm for the personalised delivery of insulin for ...
Breaking Medicine Technology: