Navigation Links
Managing Bioequivalence Studies to Optimize the Quality, Cost, and Speed of Generics Manufacturing

CHAPEL HILL, N.C., Aug. 25, 2011 /PRNewswire/ -- The global generics drug market has grown to $120 billion and with a number of blockbusters set to go off patent, the sector will see even more growth in the coming years. But as organizations involved in generics ramp up their manufacturing efforts, success hinges on the critical bioequivalence studies that are required to bring new generic drugs to market.

Best Practices, LLC conducted a wide-ranging and detailed study to help generics manufacturers identify effective strategies and processes for managing the bioequivalence component of generics development, where quality, cost and speed are all vital success factors. This benchmarking study aims to identify key cost, quality and productivity metrics for the process of conducting bioequivalence studies.

"Pharma Bioequivalence Strategies: Performance Metrics, Processes & Trends" is a new 49-page report that delivers key performance and process benchmarks that generics manufacturers can use to evaluate their own programs and costs. Beyond key benchmarks that drive bioequivalence studies such as studies per ANDA, cost per volunteer, cost per sample, the research study provides a clear picture of organizations' use of outsourcing for bioequivalence (BE) studies. In all, the report identifies:         

  • Key industry metrics for bioequivalence program costs 
  • Geographic trends in bioequivalence testing 
  • 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 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. The study includes insights drawn from primary research involving 20 executives at 18 leading generic pharmaceutical manufacturing companies.


Best Practices, LLC serves 48 of the world's 50 top pharmaceutical companies.  For 17 years, we have conducted 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 information about the company, go to

SOURCE Best Practices, LLC
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Vivo Ventures Announces Promotions of Dr. Chen Yu and Dr. James Zhao to Managing Partner
2. Elekta to Demonstrate Advanced Solutions for Managing Cancer Safely and Effectively at ESTRO 2011
3. CareFusion Acquires Technology for Sorting and Managing Dangerous Pharmaceutical Waste
4. ABSTRAL® (fentanyl) Sublingual Tablets CII, First-in-class, Sublingual, Immediate Release Opioid for Managing Breakthrough Cancer Pain, Now Available in the U.S.
5. 2P2D Ltd. Announces the Appointment of Tovi Bachar, Former Managing Director of GE Healthcare Israel, as Director and Chairman
6. DNA Direct Announces New Health Plan Clients Managing Molecular Diagnostic and Genetic Tests
7. States, Federal Government Could Save $30 Billion by Managing Medicaid Pharmacy More Like Medicare and Commercial Sector Programs
8. Point-of-Care Partners Recognized for Role in Managing SEMI
9. Skytron Highlights RFID-RTLS Cost Saving Solutions in the OR at Managing Todays OR Suite Conference
10. Elsevier Appoints Suzanne BeDell as Managing Director, Science and Technology (S&T) Books
11. Elsevier Appoints Martin OMalley as Managing Director of New Global Sales Group in Science & Technology Division
Post Your Comments:
(Date:6/24/2016)... -- Research and Markets has announced ... Applications, Technologies, Forecasts" report to their offering. ... Smart Skin, Structural Health Monitoring, Composite Smart Structures, ... involves electronic and/or electrical components and circuits that ... such as vehicle bodies or conformally placed upon ...
(Date:6/24/2016)... According to a new market ... Needles, Safety Pen Needles), Needle Length (4mm, 5mm, 6mm, ... of Purchase (Retail, Non-Retail) - Trends & Global Forecasts ... market for the forecast period of 2016 to 2021. ... by 2021 from USD 1.65 Billion in 2016, growing ...
(Date:6/23/2016)... 23, 2016 Research and Markets has ... - Forecast to 2022" report to their offering. ... for the patients with kidney failure, it replaces the function ... the patient,s blood and thus the treatment helps to keep ... in balance. Increasing number of ESRD patients ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet ... product that was developed to enhance the health of felines. The formula is all-natural ... two main herbs in the PawPaws Cat Kidney Support Supplement Soft Chews ...
(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)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX ... Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over ... Cut Pro X . Simply select a ProHand generator and drag it above media ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... recover from injury. Recently, he has implemented orthobiologic procedures as a method for ... is one of the first doctors to perform the treatment. Orthobiologics are substances ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... A recent ... that most people are unfamiliar with. The article goes on to state that individuals ... also many of these less common operations such as calf and cheek reduction. The ...
Breaking Medicine News(10 mins):