Navigation Links
Managing Bioequivalence Studies to Optimize the Quality, Cost, and Speed of Generics Manufacturing
Date:8/25/2011

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 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. The study includes insights drawn from primary research involving 20 executives at 18 leading generic pharmaceutical manufacturing companies.

ABOUT BEST PRACTICES, LLC

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 www.best-in-class.com.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... , Oct. 12, 2017 AVACEN Medical , ... company with their  2017 New Product Innovation Award for ... extensive primary and secondary medical device market research by Frost ... its first-to-market OTC, drug-free pain relief product, the AVACEN 100, ... to treating fibromyalgia widespread pain. ...
(Date:10/11/2017)... Texas , Oct. 11, 2017  True ... services, has amplified its effort during National Breast ... about hereditary cancer risks. ... of Clinical Oncology calculated that more than 10 ... have inherited mutations in BRCA1 or BRCA2 and have ...
(Date:10/5/2017)... , Oct. 5, 2017  In response ... of Oral and Maxillofacial Surgeons (AAOMS) released prescribing ... – to be used as a first-line therapy ... Recognizing the ... AAOMS White Paper "Opioid Prescribing: Acute and Postoperative ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... The Visiting Nurse Association (VNA) of Somerset Hills is proud to host ... items from across the nation, this holiday-themed event will raise funds and awareness for ... The boutique will be open Saturday, November 4 (10:00 a.m. – 5:00 p.m.) ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, ... lowdown on sciatica in a new episode of "Success Files," which is an ... and innovation and investigates each subject in-depth with passion and integrity. , Sciatica ...
(Date:10/12/2017)... ... 12, 2017 , ... First Healthcare Compliance (FHC), an industry ... a range of technology and learning solutions at the 68th Annual American Healthcare ... be held October 14–18, 2017 at the Mandalay Bay Resort in Las Vegas, ...
(Date:10/12/2017)... CITY, Fla. (PRWEB) , ... October 12, 2017 , ... ... cold therapy products, announced today the introduction of an innovative new design of the ... multipurpose pad so you get maximum comfort while controlling your pain while using cold ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... has recently contributed a medical article to the newly revamped Cosmetic Town ... article spotlights the hair transplant procedure known as Follicular Unit Extraction ...
Breaking Medicine News(10 mins):