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   '/>"/>

SOURCE Best Practices, LLC
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

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:1/15/2014)... , Jan. 15, 2014 ... research report is available in its ... Markets and Technologies for Advanced Drug ... of Administration ...
(Date:1/14/2014)... 2014 HeartWare International, Inc . (NASDAQ: ... miniaturized circulatory support technologies that are revolutionizing the treatment ... revenues for the fourth quarter of 2013 will be ... approximately $208 million. "Our full-year revenue growth ...
(Date:1/14/2014)... HILLS, Calif. , Jan. 14, 2014 The Brandeis Medical ... Los Angeles a premier and affordable laser tattoo removal ... special. Dr. Brandeis, focus is in providing high quality cosmetic services ... all patients. " Southern California has ...
Breaking Medicine Technology:Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 2Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 3Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 4Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 5Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 6Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 7Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 8Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 9Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 10Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 11Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 12Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 13Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 14Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 15Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 16HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 2HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 3HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 4Beverly Hills Physician Features Tattoo Removal with the Astanza Duality Laser, Offers $99 Special 2
... , , , , SAN DIEGO and TOKYO, Dec. ... announced that they have entered into a worldwide agreement to ... non-oncology indications. This partnership includes AC220, Ambit,s lead clinical-stage ... earlier this month in relapsed/refractory acute myeloid leukemia (AML), and ...
... Amnis Corporation, a manufacturer of advanced cell imaging systems, ... Annual J.P. Morgan Healthcare Conference. The Conference will be held ... Francisco. David Basiji, Ph.D., Amnis, President and Chief Executive ... in Room F and will discuss the company,s novel technology, ...
Cached Medicine Technology:Ambit Biosciences and Astellas Enter Strategic Partnership to Research, Develop and Commercialize FLT3 Kinase Inhibitors in Multiple Indications 2Ambit Biosciences and Astellas Enter Strategic Partnership to Research, Develop and Commercialize FLT3 Kinase Inhibitors in Multiple Indications 3Ambit Biosciences and Astellas Enter Strategic Partnership to Research, Develop and Commercialize FLT3 Kinase Inhibitors in Multiple Indications 4Ambit Biosciences and Astellas Enter Strategic Partnership to Research, Develop and Commercialize FLT3 Kinase Inhibitors in Multiple Indications 5
(Date:7/10/2014)... felt better prepared to respond to an active shooter ... new study in the journal Prehospital and Disaster ... examine the EMS provider comfort level with respect to ... been neutralized or working with law enforcement personnel during ... School shooting, the Virginia Tech campus shooting, the 2009 ...
(Date:7/10/2014)... as the "Mississippi baby" an infant seemingly cured of ... prolonged remission of HIV infection in The New England ... HIV after more than two years of not taking antiretroviral ... specialist and researchers involved in the case. , ... young child, the medical staff involved in the child,s care, ...
(Date:7/10/2014)... Estonian-born Katerina Alba,s research at the University of Huddersfield ... the most popular emulsion-based food products such as ... is starting to gain an international profile for her ... and food science at the University and now she ... with her supervisor, Dr Vassilis Kontogiorgos, she is investigating ...
(Date:7/10/2014)... were more likely to be diagnosed with more ... survived for shorter times than prostate cancer patients ... found. , The negative outcomes may be the ... the mentally ill, depression,s impact on biological cancer ... his general health and disinterest in receiving more ...
(Date:7/9/2014)... WASHINGTON, DC (July 10, 2014) If you think winning ... fun for kids think again: Winning along with other mental ... each of which falls into one of 11 big fun ... that winning is all important when it comes to the ... identify and quantify what goes into this elusive conceptuntil now. ...
Breaking Medicine News(10 mins):Health News:Active shooter training increases comfort level of emergency responders 2Health News:'Mississippi Baby' now has detectable HIV, researchers find 2Health News:'Mississippi Baby' now has detectable HIV, researchers find 3Health News:World interest in research work on the benefits of the Okra plant 2Health News:Depressed men with prostate cancer are diagnosed later stage, get less effective therapies 2Health News:Being a good sport ranks as the top 'fun' factor in study of youth sports 2Health News:Being a good sport ranks as the top 'fun' factor in study of youth sports 3
... Crazy While They Work...30,000+ Dentists Converge in Chicago February ... issued by the Chicago Dental Society:Who: The Chicago ... to find out some wacky, unusual, and just plain ... chair.As we countdown to CDS,s annual Midwinter Meeting, one ...
... to new dental techniques, , , TUESDAY, Feb. 24 (HealthDay ... immune function and the development of skin and the ... Oregon State University researchers have found. , Their discovery ... to new methods of repairing damaged enamel and preventing ...
... music doesn,t necessary cause promiscuity, experts stress, , , ... proof that raunchy music makes kids have sex, but a ... kind of link between "degrading" songs and teenage sexual activity. ... to certain messages in music are more likely to copy ...
... uses search engine optimization and individualized marketing to offer ... 24 Creative Marketing Solutions, LLC (CMS) today announced ... cost-effective way for veterinary practices to market themselves online, ... Much more than just a listing service, My Hometown ...
... Make Them Effective , ... St. Louis, MO (PRWEB) February 24, 2009 ... or some would say failing - health care system at further risk. ... rising. Also, faced with tighter budgets and escalating health care costs, even ...
... 24 With President Obama preparing to,present his budget ... on,his economic stimulus initiatives and a renewed call for ... released new data,on how the most comprehensive healthcare fix ... national economy. , Overall, expanding ...
Cached Medicine News:Health News:Top 5 Most Annoying Dental Patient Behaviors 2Health News:Scientists Find Gene for Tooth Enamel 2Health News:'Degrading' Lyrics Linked to Teen Sex 2Health News:'Degrading' Lyrics Linked to Teen Sex 3Health News:Creative Marketing Solutions Launches My Hometown Vet, Giving Veterinary Practices Better Visibility Online 2Health News:Creative Marketing Solutions Launches My Hometown Vet, Giving Veterinary Practices Better Visibility Online 3Health News:Health and Wellness Programs in a Tight Economy 2
1% tryptone, 0.5% yeast extract, 1.0% Sodium Chloride. 1.5% agararose...
Luria bertani broth: 1.0% Tryptone, 0.5% Yeast Extract, 1.0% Sodium Chloride....
... flowing powder. pH: pH(4.7%, H 2 O): ... Yeast Extract: 47% Potassium Phosphate Dibasic: 25% Potassium ... 47 gm powder per liter of purified water. ... and recombinant proteins than LB media by allowing ...
1.2% Tryptone, 2.4% Yeast Extract, 0.4% Glycerol, with 100ml of 10x Phosphate buffer supplement (0190-01)....
Medicine Products: