Approved Drug Products with Therapeutic Equivalence Evaluations - FDA Orange Book 31st Edition (2011) PDF Download
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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: 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: 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: 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: 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: John M. Centanni
Publisher: CRC Press
ISBN: 1498758851
Category : Medical
Languages : en
Pages : 357
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Book Description
This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are increased for new technical fields such as cell and tissue engineering. Further, illustrations or figures are added to each chapter to emphasize particular points.
Author: Robert O. Williams III
Publisher: Springer Science & Business Media
ISBN: 1461411440
Category : Medical
Languages : en
Pages : 656
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Book Description
This volume is intended to provide the reader with a breadth of understanding regarding the many challenges faced with the formulation of poorly water-soluble drugs as well as in-depth knowledge in the critical areas of development with these compounds. Further, this book is designed to provide practical guidance for overcoming formulation challenges toward the end goal of improving drug therapies with poorly water-soluble drugs. Enhancing solubility via formulation intervention is a unique opportunity in which formulation scientists can enable drug therapies by creating viable medicines from seemingly undeliverable molecules. With the ever increasing number of poorly water-soluble compounds entering development, the role of the formulation scientist is growing in importance. Also, knowledge of the advanced analytical, formulation, and process technologies as well as specific regulatory considerations related to the formulation of these compounds is increasing in value. Ideally, this book will serve as a useful tool in the education of current and future generations of scientists, and in this context contribute toward providing patients with new and better medicines.
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.
