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 metri
'/>"/>

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

Page: 1 2

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:8/28/2014)...  Seres Health, a clinical-stage therapeutics company developing ... microbiome, announced today that Dr. David Cook ... Chief Scientific Officer, will be presenting at the ... (ICAAC). The presentation will highlight the scientific and ... bacterial spores derived from the human microbiome, and ...
(Date:8/28/2014)... PITTSBURGH , Aug. 28, 2014 /PRNewswire-iReach/ -- ... exhibiting at the 9 th Annual Global ... , September 8-9 th . The Global ... industry leaders in small molecule and biologic pharmaceutical ... address challenges that today,s manufacturers face, such as ...
(Date:8/28/2014)... Aug. 28, 2014 Reportlinker.com ... report is available in its catalogue: ... Asia-Pacific Markets to 2020 - Novel ... in Newly Diagnosed and Recurrent GBM ... Glioblastoma Multiforme Therapeutics ...
Breaking Medicine Technology:Seres Health to Present Clinical Findings at ICAAC 2014 Conference 2Gateway Analytical to Promote Particulate Identification Services at the 9th Annual Global Pharma Manufacturing Summit 2Gateway Analytical to Promote Particulate Identification Services at the 9th Annual Global Pharma Manufacturing Summit 3Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM 2Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM 3Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM 4Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM 5Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM 6Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM 7Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM 8Glioblastoma Multiforme Therapeutics in Asia-Pacific Markets to 2020 - Novel Therapeutic Approaches Target High Unmet Need in Newly Diagnosed and Recurrent GBM 9
... WILMINGTON, Del., Oct. 26 Next Intelligence Corporation ( ... today announced the expansion of its channel program for ... and system integrators (SI) to explore the growing health ... members sales leads, education on technical and selling aspects ...
... (Nasdaq: GTIV ), the nation,s largest provider of ... present at the Oppenheimer 21st Annual Healthcare Conference in New ... and the Credit Suisse 2010 Healthcare Conference in Phoenix, AZ ... 10, 2010. The presentations will be available to ...
Cached Medicine Technology:Next Intelligence Health Expands US Channel Program 2Gentiva® Health Services to Present at the Oppenheimer and Credit Suisse Healthcare Conferences 2Gentiva® Health Services to Present at the Oppenheimer and Credit Suisse Healthcare Conferences 3
(Date:8/29/2014)... Aug. 29, 2014 (HealthDay News) -- The main ... the Middle East and North Africa originated in ... studied so-called community-acquired methicillin-resistant Staphylococcus aureus ... have not recently been hospitalized. These infections typically ... person-to-person contact or through touching contaminated objects such ...
(Date:8/29/2014)... August 29, 2014 For the fifth ... (Meso Foundation) will be observing September 26th as Mesothelioma ... Plaza, in New York. , Members of the ... RSVP . The Foundation will be providing t-shirts and ... years, mesothelioma community members have received attention from ...
(Date:8/29/2014)... 29, 2014 PreDiabetes Centers , the ... season by offering Web shoppers a 20% discount off orders ... the Company’s online healthy living shop, beginning September 1. ... priority when heading into the chilly fall season. , Autumn’s ... this season, people usually ditch the healthy salads and opt ...
(Date:8/29/2014)... August 29, 2014 Innovations Television, produced by ... upcoming episodes of Innovations, focusing on health and elderly care, ... show the number of Americans over 65 will nearly double ... to 20% in 2030, for a total of 72 million ... health, most have at least one chronic condition and use ...
(Date:8/29/2014)... Raleigh, NC (PRWEB) August 29, 2014 ... validated the idea that progression-free survival correlates with overall ... article on the new research. Click here to ... UK and The Netherlands studied the cases of 523 ... European chemotherapy studies. , “PFSR-18 [progression-free survival at ...
Breaking Medicine News(10 mins):Health News: European MRSA Originated in Sub-Saharan Africa, Study Finds 2Health News:Organization to Raise Awareness of Mesothelioma on the Today Show 2Health News:PreDiabetes Centers Online Store Launches Fall Savings Event 2Health News:Innovations with Ed Begley, Jr., Seeking Content for Upcoming Series on Health and Elder Care 2Health News:European Study Says Disease Progression Predicts Mesothelioma Survival Better Than Treatment Response, According to Surviving Mesothelioma 2
... Heart Failure Nurses in Boston, June ... 26-28, ... (AAHFN) 2008 Annual Meeting "Raising the Bar in Heart,Failure Care" is scheduled ... research and ways to,improve patient care. The compelling agenda and wonderful ...
... VYTEX(TM) NRL: THE NEW STANDARDIZED SOURCE MATERIAL FOR THE ... PRODUCTS ... Rapra Technology Limited has invited,Vystar Corporation to present its ... Dispersions Conference 2008 in Madrid in,January. "Vytex(TM) Natural ...
... patients with advanced kidney cancer whose options run out after ... , The study, presented today (Wednesday) at the European ... drug, axitinib, shrank tumours and delayed progression of the disease ... to treat. , In the study, scientists gave axitinib to ...
... Paramount Acquisition,Corp. (OTC Bulletin Board: PMQC, PMQCU, PMQCW) ... directors has established the close of,business on October 1, ... will be entitled to receive notice of and to ... held to consider and vote,on the previously announced acquisition ...
... Consider Proposals and Variations, LOS ANGELES, ... ISCR) a leading e-health Wi-Fi PDA technology ... DME and EMR applications,and the distributor of ... surgical products, announced today that its Board ...
... Spain: Using an ultrasound-guided fine needle to biopsy lymph ... worldwide from having to undergo unnecessary and sometimes unpleasant ... research indicates. , In a study presented today ... Barcelona, scientists found that the less invasive technique produced ...
Cached Medicine News:Health News:AAHFN's 2008 Annual Meeting in Boston Will Be 'Raising the Bar in Heart Failure Care' 2Health News:Global Latex Conference to Showcase Vytex(TM) NRL 2Health News:Experimental drug shows promise in advanced kidney cancer 2Health News:Paramount Acquisition Corp. Announces Record Date of October 1, 2007 for Proposed Acquisition of Chem Rx 2Health News:Paramount Acquisition Corp. Announces Record Date of October 1, 2007 for Proposed Acquisition of Chem Rx 3Health News:Paramount Acquisition Corp. Announces Record Date of October 1, 2007 for Proposed Acquisition of Chem Rx 4Health News:InstaCare Corp. Reviewing M&A Plans 2Health News:Less invasive lymph node biopsy method could spare thousands unnecessary operations 2
Cuffed pediatric endotracheal tubes, available from 2.5 mm to 4.5 mm inside diameter. Ruschelit® PVC. Magill tip - nasoral. X-ray opaque line. Graduated. Single use. Sterile...
Ruschelit® PVC. Murphy eye-nasoral. Black positioning ring. High volume/low pressure cuff. X-ray opaque line. Graduated. Single use....
Ruschelit® PVC. Siliconized. Stainless steel spiral reinforced. Murphy eye. High volume/low pressure cuff. Connector is permanently fixed into the tube. X-ray opaque. Graduated. Single use. Steri...
... eye. Laser resistant foam surrounds the lower 17cm ... other) 40cm (16") long, Single Use. The tracheal ... optimum visibility within the operating site, while maintaining ... laser-guard of approx. 17cm in length proximal to ...
Medicine Products: