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Drug recrystallization in drug-in-adhesive transdermal delivery system: A case study of deteriorating the mechanical and rheological characteristics of testosterone TDS.

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Title: Drug recrystallization in drug-in-adhesive transdermal delivery system: A case study of deteriorating the mechanical and rheological characteristics of testosterone TDS.
Authors: Mohamed LA; Division of Pharmaceutical Manufacturing II, Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA., Kamal N; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA., Elfakhri KH; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA., Willett D; Division of Pharmaceutical Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MO, USA., Wokovich A; Division of Pharmaceutical Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MO, USA., Strasinger C; Division of New Drug Products II, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA., Cruz CN; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA., Raney SG; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA., Ashraf M; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA., Zidan AS; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA. Electronic address: Ahmed.Zidan@fda.hhs.gov.
Source: International journal of pharmaceutics [Int J Pharm] 2020 Mar 30; Vol. 578, pp. 119132. Date of Electronic Publication: 2020 Feb 10.
Publication Type: Journal Article
Journal Info: Publisher: Elsevier/North-Holland Biomedical Press Country of Publication: Netherlands NLM ID: 7804127 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-3476 (Electronic) Linking ISSN: 03785173 NLM ISO Abbreviation: Int J Pharm Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Drug recrystallization in drug-in-adhesive transdermal delivery system: A case study of deteriorating the mechanical and rheological characteristics of testosterone TDS.
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  Data: <searchLink fieldCode="AU" term="%22Mohamed+LA%22">Mohamed LA</searchLink>; Division of Pharmaceutical Manufacturing II, Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Kamal+N%22">Kamal N</searchLink>; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Elfakhri+KH%22">Elfakhri KH</searchLink>; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Willett+D%22">Willett D</searchLink>; Division of Pharmaceutical Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MO, USA.<br /><searchLink fieldCode="AU" term="%22Wokovich+A%22">Wokovich A</searchLink>; Division of Pharmaceutical Analysis, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MO, USA.<br /><searchLink fieldCode="AU" term="%22Strasinger+C%22">Strasinger C</searchLink>; Division of New Drug Products II, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Cruz+CN%22">Cruz CN</searchLink>; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Raney+SG%22">Raney SG</searchLink>; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.<br /><searchLink fieldCode="AU" term="%22Ashraf+M%22">Ashraf M</searchLink>; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA.<br /><searchLink fieldCode="AU" term="%22Zidan+AS%22">Zidan AS</searchLink>; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Maryland, USA. Electronic address: Ahmed.Zidan@fda.hhs.gov.
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  Data: <searchLink fieldCode="JN" term="%227804127%22">International journal of pharmaceutics</searchLink> [Int J Pharm] 2020 Mar 30; Vol. 578, pp. 119132. <i>Date of Electronic Publication: </i>2020 Feb 10.
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              Text: 2020 Mar 30
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