Navigation Links
Managing Bioequivalence Studies to Optimize Cost, Quality, and Outsourcing of Generics Manufacturing
Date:2/10/2013

CHAPEL HILL, N.C., Feb. 10, 2013 /PRNewswire/ -- The global generics drug market has grown substantially in previous years and is expected to see even more growth in the coming years. Given the rapid progress of the sector, organizations must critically manage and assess bioequivalence studies that are mandatory when bringing new generic drugs to market.

Development, quality, cost and, speed are all vital success factors in the sector of generics. In order to help generics manufacturers identify effective strategies and processes for managing the bioequivalence component of generics development, benchmarking research firm Best Practices, LLC conducted a wide-ranging and detailed study. The benchmark report delivers key performance and process benchmarks that generics manufacturers can use to evaluate their own programs and costs.

"Pharma Bioequivalence Strategies: Performance Metrics, Processes & Trends" is a new 49-page benchmarking study that aims to identify key cost, quality and productivity metrics for the process of conducting bioequivalence studies. Beyond key benchmarks that drive bioequivalence studies such as cost per volunteer, studies per ANDA, and cost per sample, the research also provides a clear picture of organizations' use of outsourcing for bioequivalence.

The study includes insights drawn from primary research involving 20 executives at 18 leading generic pharmaceutical manufacturing companies. Other key topics the study identifies include:

  • Geographic trends in bioequivalence testing 
  • Key industry metrics for bioequivalence program costs 
  • Sponsor support activities that drive bioequivalence success 
  • Successful QA structures and strategies in bioequivalence 
  • Trends in use of pilot studies, power and e-submissions  

Go to http://www3.best-in-class.com/rr1109.htm to review a complimentary summary with samples of metrics such as use of CROs for BE studies in emerging markets, percentage of organizations with quality assurance groups, and benefits for use of pilot studies.

For related research, visit our Best Practices, LLC Web site at http://www.best-in-class.com/.

ABOUT BEST PRACTICES, LLC

Best Practices, LLC is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide. Best Practices, LLC's clients include all the top 10 and 48 of the top 50 global healthcare companies. The firm conducts primary research and consulting using its comprehensive proprietary benchmarking tools and analysis. The operational insights, findings and analysis form the basis for our Benchmarking Reports, databases and advisory services to support executives in commercial and R&D operations. Best Practices, LLC believes in the 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.


'/>"/>
SOURCE Best Practices, LLC
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Vorsitzender & Managing Director von Glenmark Pharma - Herr Glenn Saldanha - erhielt Preis des Schweizer Botschafters für außergewöhnliche Innovation
2. Jeffrey Wasserstein Joins Greenhill as Managing Director Focused on the Pharmaceutical Sector
3. Cell Therapeutics, Inc. (CTI) Appoints Former Managing Director, Head of West Coast Biotechnology for Oppenheimer/CIBC Matthew J. Plunkett Executive Vice President, Corporate Development
4. CVS Caremark Charitable Trust Partners with National Association of Community Health Centers to Create Innovative Grant Program Focused on Managing Chronic Disease
5. At SIIM 2012 Siemens Healthcare Demonstrates Departmental IT Solutions That Help Administrators Increase Access while Managing Costs
6. Brainybrawn, Inc. announces Launch of its Web based Medical College Information Management Solution (Sanvi MCIMS), as well as Receipt of Order for Its Comprehensive Restaurant Information Management Solution for Managing Chain of Restaurants (Sanvi
7. Studies Show Pharma has a Strong Opportunity to Market to New Decision Makers via Digital Channels
8. GLP Preclinical Studies Demonstrate nContact Ablation Lesions Are Complete and Transmural
9. Lilly Discontinues One of Three Phase 3 Rheumatoid Arthritis Registration Studies for Tabalumab
10. The Lancet Publication Of LAPLACE-TIMI 57 And MENDEL Studies Showed AMG 145 Significantly Reduced LDL Cholesterol
11. Novel Apolipoprotein A-I Therapy, CSL112, May Represent New Option for Reducing Recurrent Heart Attack Risk, Early CSL Studies Show
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 2016 Dublin ... addition of the " Global Markets for Spectroscopy ... This report focuses on the ... review, including its applications in various applications. The report ... includes three main industries: pharmaceutical and biotechnology, food and ...
(Date:6/24/2016)... 2016 The Academy of Managed Care Pharmacy ... that would allow biopharmaceutical companies to more easily share ... formulary and coverage decisions, a move that addresses the ... The recommendations address restrictions in the sharing ... drug label, a prohibition that hinders decision makers from ...
(Date:6/24/2016)... and SAN CLEMENTE, Calif. , June ... -based mobile pulmonary function testing company, is now able to ... devices developed by ndd Medical Technologies , Inc. ... done in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® , ... , can get any needed testing done in the comfort of ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... ... and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes ... important health care topics including advance care planning, healthcare costs and patient and ...
(Date:6/25/2016)... ... 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his ... David Geffen School of Medicine at UCLA. He trained in Internal Medicine at Scripps ... in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Those who ... with these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, ... Marne, Michigan, has released tools for healthy coping following a traumatic event. , Trauma ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. ... accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of orthodontics, ... and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to orthodontic ...
(Date:6/24/2016)... York, NY (PRWEB) , ... June 24, 2016 ... ... publication Haute Living, is proud to recognize Dr. Barry M. Weintraub as a ... that “the most beautiful women in the world, and the most handsome men, ...
Breaking Medicine News(10 mins):