| Improved therapeutic entities derived from known generics as an unexplored source of innovative drug products. | |
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MedLine Citation:
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PMID: 21968337 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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With a New Drug Application (NDA) innovative drug therapies are reaching the market in a specific dosage form for one or more clinically proven indications of which after expiration of the patent or the data exclusivity copies are launched using Abbreviated New Drug Applications (ANDA). Advanced therapies that emerged from launched molecules during their product life-cycle have gained considerable attention as clinical practice provides evidence for additional therapeutic values, patient centric delivery systems show improved therapeutic outcomes or emerging technologies offer efficiency gains in manufacturing or access to emerging markets. The USA and European regulatory framework has set reasonable regulations in place for these "Supergenerics" or "hybrid" applications. While these regulations are relatively recent the pharmaceutical industry is just starting to use this route for their product development and life-cycle management. From a clinical perspective the potential for advanced product development have been demonstrated. Yet, there is still a lag of common understanding between the different stakeholders regarding the development, application process and commercial incentive in developing enhanced therapeutic entities based on existing drug products for the market. |
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Authors:
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Sven Stegemann; Imre Klebovich; István Antal; Henning H Blume; Kálmán Magyar; György Németh; Tamás L Paál; Willibald Stumptner; György Thaler; Armand Van de Putte; Vinod P Shah |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-9-24 |
Journal Detail:
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Title: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences Volume: - ISSN: 1879-0720 ISO Abbreviation: - Publication Date: 2011 Sep |
Date Detail:
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Created Date: 2011-10-4 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9317982 Medline TA: Eur J Pharm Sci Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
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Copyright © 2011 Elsevier B.V. All rights reserved. |
Affiliation:
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Capsugel, Bornem, Belgium. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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