Author: Food and Drug Administration
Publisher: DrugPatentWatch.com
ISBN: 193489981X
Category : Medical
Languages : en
Pages : 1253

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Book Description
FDA Orange Book 31st Edition - 2011 (Approved Drug Products With Therapeutic Equivalence Evaluations)

Author: Food and Drug Administration
Publisher: DrugPatentWatch.com
ISBN: 1934899828
Category : Medical
Languages : en
Pages : 1299

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Book Description
FDA Orange Book 32nd Edition - 2012 (Approved Drug Products With Therapeutic Equivalence Evaluations)

Author: Food and Drug Administration
Publisher: DrugPatentWatch.com
ISBN: 1934899798
Category : Medical
Languages : en
Pages : 1161

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Book Description
FDA Orange Book 29th Edition - 2009 (Approved Drug Products With Therapeutic Equivalence Evaluations)

Author: DrugPatentWatch
Publisher: DrugPatentWatch.com
ISBN: 1934899852
Category : Medical
Languages : en
Pages : 100

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Book Description

NESINA Drug Profile, 2023

This report focuses on NESINA and covers the following critical aspects of this drug:

• United States patents
• Expired United States patents
• FDA Paragraph IV patent challenges
• District Court patent litigation
• European supplementary protection certificates (SPCs)
• Clinical trials
• Drug prices
• Finished product suppliers
• Raw active pharmaceutical ingredient (API) sources

Author: DrugPatentWatch
Publisher: DrugPatentWatch.com
ISBN: 1934899836
Category : Medical
Languages : en
Pages : 101

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Book Description

MOVIPREP Drug Profile, 2023

This report focuses on MOVIPREP and covers the following critical aspects of this drug:

• United States patents
• FDA Paragraph IV patent challenges
• District Court patent litigation
• European supplementary protection certificates (SPCs)
• Clinical trials
• Drug prices
• Annual sales revenues
• Finished product suppliers

Author: Food and Drug Administration
Publisher: DrugPatentWatch.com
ISBN: 1934899801
Category : Medical
Languages : en
Pages : 1115

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Book Description
FDA Orange Book 30th Edition - 2010 (Approved Drug Products With Therapeutic Equivalence Evaluations)

Author: Food and Drug Administration
Publisher: DrugPatentWatch.com
ISBN: 1934899755
Category : Medical
Languages : en
Pages : 1039

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Book Description
FDA Orange Book 25th Edition - 2005 (Approved Drug Products With Therapeutic Equivalence Evaluations)

Author: Markham C. Luke
Publisher: Elsevier Health Sciences
ISBN: 0323849709
Category : Medical
Languages : en
Pages : 121

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Book Description
In this issue, guest editors bring their considerable expertise to this important topic.Provides in-depth reviews on the latest updates in the field, providing actionable insights for clinical practice. Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create these timely topic-based reviews.

Author: OECD
Publisher: OECD Publishing
ISBN: 9264071245
Category :
Languages : en
Pages : 12

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Book Description
The bacterial reverse mutation test uses amino-acid requiring at least five strains of Salmonella typhimurium and Escherichia coli to detect point mutations by base substitutions or frameshifts. The principle of this bacterial reverse mutation test ...

Author: David B. Young
Publisher: Springer Science & Business Media
ISBN: 1468460366
Category : Medical
Languages : en
Pages : 299

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Book Description
This book represents the invited presentations and some of the posters presented at the conference entitled "In Vitro-In Vivo Relationship (IVIVR) Workshop" held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development.