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:10/10/2019)... ... October 10, 2019 , ... Ovation Fertility is once again ... reproductive medicine, with six abstracts accepted for poster presentations at the ASRM 2019 ... 12-16, 2019, in Philadelphia. , “Ovation will have a prominent presence in the ...
(Date:10/9/2019)... AVERILL PARK, N.Y. (PRWEB) , ... October 09, ... ... conference will present the nation’s only complete teaching of Yoga Science and AMI ... and Science of Yoga, this comprehensive training, held October 22-26, 2019 at ...
(Date:10/8/2019)... Charleston, SC (PRWEB) , ... October 08, 2019 ... ... Sedation Dentistry of Charleston. Dr. Robert Carimi and his caring team are thrilled ... who suffer from dental anxiety in Charleston, SC. The mission of ...
Breaking Medicine Technology:
(Date:10/10/2019)... N.Y. (PRWEB) , ... October 10, 2019 , ... ... Sports Nutrition) Annual Conference, Nutrition 21 was excited to hear the significant results ... the significant blood flow impact of Nitrosigine®. The clinical study poster entitled “The ...
(Date:10/8/2019)... ... ... SoCal Adolescent Wellness announces the opening of a second location in Lake ... better serve the families in Orange County," said Becca Moody, CEO of SoCal Adolescent ... this pre-intervention program has on the lives of the adolescents and families we work ...
(Date:10/8/2019)... ... October 08, 2019 , ... ... services for the Department of Veterans Affairs Community Care Referrals and Authorizations program. ... of the VA’s Health Share Referral Manager (HSRM), an enterprise-wide system used by ...
(Date:10/8/2019)... ... 2019 , ... PotentiaMetrics, an Austin, TX based healthcare data ... Officer. Dr. Henderson will be responsible for the development and management of the ... Chair of both the Informatics Governance and the Inpatient Clinical Informatics Committees at ...
(Date:10/8/2019)... ... October 08, 2019 , ... METAvivor Research and Support Inc., ... the launch of its Stage IV Stampede campaign. The campaign will commence with two ... that will include an advocacy boot camp, a march, a Die-In (hosted by partner ...
Breaking Medicine News(10 mins):