Navigation Links
Absorption Systems Registers with FDA as a Generic Drug Facility under GDUFA
Date:3/25/2013

generic drug applications, their growing complexity, and the need to inspect the growing number of generic drug facilities located overseas.

Absorption Systems' activities related to GDUFA involve classification of drug active ingredients according to the BCS. Part of the FDA drug approval pathway since 2000, the BCS classifies drugs according to the solubility and permeability of their active pharmaceutical ingredients (APIs). Absorption Systems is the world leader in the measurement of drug permeability for BCS classification. Drugs that meet the criteria for BCS Class I (high permeability and solubility) are eligible for a biowaiver, which simplifies the process of drug development.

Patrick Dentinger, President and CEO of Absorption Systems, commented that "The world is gradually realizing what a unique and reliable approach to accelerating product approval the BCS is. Whereas GDUFA is expected to reduce the backlog of generic reviews, the BCS eliminates unnecessary human testing and dramatically reduces both the time and cost of product approval."

Collectively, these steps will benefit BCS adopters in the US and around the globe. The interest and growth in BCS applications have regulatory agencies around the world taking notice. With that in mind, Absorption Systems
'/>"/>

SOURCE Absorption Systems
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Absorption Systems announces novel test platform for interactions with the BCRP transporter
2. Delcath Systems, Inc. Secures $20 Million Credit Facility
3. Leica Biosystems Receives FDA Approval for the Fully Automated Bond Oracle™ HER2 IHC System on the Leica BOND-MAX
4. Varian Medical Systems Reports Results for Second Quarter of Fiscal Year 2012
5. Varian Medical Systems and Siemens Healthcare Announce Global Collaboration to Advance Clinical Capabilities and Offerings in Radiotherapy and Radiosurgery
6. Middle East and Africa Endoscopy Devices Market Outlook to 2017 - Flexible Endoscopes, Rigid Endoscopes, Endoscopy Visualization Systems, Capsule Endoscope Systems and Others
7. New Forecast Shows Patient Monitoring Systems Market to Reach $18.9 billion by 2016
8. Surgical Information Systems Recognizes Clients for Financial, Clinical, and Operational Improvements
9. Veeva Systems Announces Dramatic Growth in Europe
10. PLC Systems Reports First Quarter 2012 Results
11. Varian Medical Systems to Showcase Radiosurgery Technology for Non-invasive Treatment of Early Stage Inoperable Lung Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or the "Company"), a specialty ... disease and overall health is pleased to provide you with ... outlook for 2015 from the CEO, Mr. Eugene Bortoluzzi ... like to take this opportunity to share with you the ...
(Date:1/22/2015)... SAN DIEGO , Jan. 22, 2015  Profil Institute ... focused on diabetes and obesity, announced today a new ... Drug Development,  published by Springer, a leading global scientific ... extensively analyze and illustrate techniques for use in early ...
(Date:1/22/2015)... Research and Markets ( http://www.researchandmarkets.com/research/x3hp3g/microbiology ) ... Testing/Clinical Microbiology Market by Product, Clinical Application & ... report to their offering. Clinical microbiology ... the detection of infectious diseases. The respiratory diseases ...
Breaking Medicine Technology:Pivotal Therapeutics: Year in Review and CEO Update 2Pivotal Therapeutics: Year in Review and CEO Update 3Pivotal Therapeutics: Year in Review and CEO Update 4Pivotal Therapeutics: Year in Review and CEO Update 5Pivotal Therapeutics: Year in Review and CEO Update 6Pivotal Therapeutics: Year in Review and CEO Update 7New Textbook "Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development" Provides Critical Review Of Current And Emerging Clinical Investigation Methods 2New Textbook "Translational Research Methods for Diabetes, Obesity and Cardiometabolic Drug Development" Provides Critical Review Of Current And Emerging Clinical Investigation Methods 3Global Microbiology Testing/Clinical Microbiology (Instrument, Analyzer, Incubator, Kit, Microscope, Molecular Diagnostics) Market - Forecast to 2019 2Global Microbiology Testing/Clinical Microbiology (Instrument, Analyzer, Incubator, Kit, Microscope, Molecular Diagnostics) Market - Forecast to 2019 3
... The Pharmaceutical,Research and Manufacturers of America (PhRMA) ... pipeline for major diseases affecting African,Americans to Mississippi ... pharmaceutical research companies are now testing 691 new,medicines ... or diseases that are among the top 10 ...
... 49th annual meeting recombinant factor, VIIa-albumin fusion protein ... treatment option for hemophilia patients with ... the,results of a pre-clinical study that show for the first ... human albumin, prolonging the,half- life of this therapeutic protein while ...
Cached Medicine Technology:New Report Offers Hope for Closing Health Gap for African Americans, With Nearly 700 Medicines in Pipeline 2New Report Offers Hope for Closing Health Gap for African Americans, With Nearly 700 Medicines in Pipeline 3CSL Behring Study in Animal Models Shows Feasibility of Developing a Half-Life Extended Recombinant FVIIa that Retains Biologic Activity 2CSL Behring Study in Animal Models Shows Feasibility of Developing a Half-Life Extended Recombinant FVIIa that Retains Biologic Activity 3
(Date:1/22/2015)... VogueQueen is a seasoned and trusted leader who consistently delivers ... to have it lead the wedding dress industry into the ... dresses for the global market. , “The CEO of VogueQueen ... focuses on continuing the goal of operational excellence and giving ...
(Date:1/22/2015)... is a famous wedding dress company offering many trendy designs. ... Facebook, Twitter, and Pinterest. The fans will have an opportunity ... every week. , Moreover, the company has extended its 2015 ... homepage for more information. , Angelweddingdress is a ...
(Date:1/22/2015)... the premier women’s dress supplier, has recently released its ... of AngelWeddingDress.com to find more details. , Many ... a bridal party. AngelWeddingDress offers a variety of gorgeous ... wedding dresses are specially designed for 2015. , AngelWeddingDress ...
(Date:1/22/2015)... Juvent Sports ( http://www.juventsports.com ) and David ... Show to bestow a Juvent Sports Achievement award upon ... McKitrick. The award commemorated and congratulated McKitrick for her ... won her first amateur tournament in 1979 and most ...
(Date:1/22/2015)... York, New York (PRWEB) January 22, 2015 ... filed after Fresenius Medical Care recalled its GranuFlo and ... federal multidistrict litigation underway in U.S. District Court, District ... Order dated January 20th, the Court has remanded a ...
Breaking Medicine News(10 mins):Health News:VogueQueen Unveils New Designs of Prom Dresses for 2015 2Health News:Angelweddingdress Invites Its Customers To Follow It On Facebook, Twitter, And Pinterest 2Health News:AngelWeddingDress Has Recently Released Its Collection Of 2015 Maternity Wedding Dresses 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 2Health News:All-Time Leading Female Amateur Golfer Arlene McKitrick Receives Juvent Sports Achievement Award at 2015 PGA Show 3Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 3Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 4
... , , , ... Living, Inc. (OTC Bulletin Board: TCSR), which develops, manages and owns ... agreement with Deutsche Bank Berkshire Mortgage, Inc. for the development of ... Trinity Heights , an 82-unit, $10 ...
... , , WILTON, Conn., July ... BlogHer Conference 2009 held Friday, July 24 and Saturday, July 25 ... about the importance of incidental sun exposure and give them a ... Aging Simulator. This year marked Eucerin,s first appearance at the ...
... , ANN ARBOR, Mich., July 28 ... the vendor for the Treatment Cost Calculator, an application that ... healthcare services. The Treatment Cost Calculator also shows consumers how ... , Clear Choice is headquartered in Bend, Oregon, ...
... , , , ... July 28 Uptown Mt. Lebanon is the place to be Saturday, August ... ULTRAparty , Mt. Lebanon,s premiere summer street party event, from ... provides an opportunity for the young (and young-at-heart!) to literally party ...
... , , , ... The State of Louisiana and Together Rx Access announced today ... help thousands of eligible uninsured Louisianans access immediate and meaningful savings ... , , The collaboration will use existing ...
... ISLANDIA, N.Y., July 28 CA, Inc. (Nasdaq: ... integrated infrastructure and performance management solution to ... The CA solution will help Seattle Children,s achieve the benefits of ... and automated fault isolation and root cause analysis for the infrastructure ...
Cached Medicine News:Health News:TrinityCare Senior Living Announces Funding Agreement for Fifth Senior Living Facility 2Health News:TrinityCare Senior Living Announces Funding Agreement for Fifth Senior Living Facility 3Health News:TrinityCare Senior Living Announces Funding Agreement for Fifth Senior Living Facility 4Health News:Eucerin Provides BlogHer Attendees With a Glimpse Into Their Skin's Future With Proprietary 'Time Machine' Aging Simulator 2Health News:Clear Choice Health Plans Selects Thomson Reuters to Deliver Healthcare Cost Information to Members - and Exceed State Transparency Requirements 2Health News:Clear Choice Health Plans Selects Thomson Reuters to Deliver Healthcare Cost Information to Members - and Exceed State Transparency Requirements 3Health News:Mt. Lebanon Comes Alive Saturday, August 8th with ULTRAparty 2Health News:The State of Louisiana and Together Rx Access Join Forces to Improve Prescription Access for Uninsured Residents 2Health News:The State of Louisiana and Together Rx Access Join Forces to Improve Prescription Access for Uninsured Residents 3Health News:The State of Louisiana and Together Rx Access Join Forces to Improve Prescription Access for Uninsured Residents 4Health News:Seattle Children's Hospital Deploys CA's Integrated Infrastructure and Performance Management Solution 2Health News:Seattle Children's Hospital Deploys CA's Integrated Infrastructure and Performance Management Solution 3
The iEMS Incubator/Shaker is a high performance microplate incubator and orbital shaker. Its superior temperature control and efficient orbital shaking reduce incubation times. -...
Form: Cream-colored powder Moisture: 10% Ash: 6.5% Gel Strength (1.5%): 550 950 gm/cm 2 Gel pH (1.5%): 6.0 7.5 Gel Point (1.5%): 34 38C Melting Point (1.5%): 84 88C Application: Bacterial ...
... generation of a hypoxic environment for tissue ... surface-type seal where all portions of the ... steel ring clamp for a reliable air-tight ... and bottom provide minimum gas flow resistance ...
... incubators is available, ensuring the customers to ... specific requirements. miniTHERM incubators have a capacity ... space saving. Their size corresponds approximately to ... to stack up to three units on ...
Medicine Products: