Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey.
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| Title: | Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey. |
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| Authors: | Oner ZG; Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland.; Turkish Medicines and Medical Devices Agency, Ankara, Turkey., Michel SLJ; Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland., Polli JE; Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland. |
| Source: | Annals of the New York Academy of Sciences [Ann N Y Acad Sci] 2017 Nov; Vol. 1407 (1), pp. 26-38. Date of Electronic Publication: 2017 Nov 01. |
| Publication Type: | Journal Article; Review; Research Support, U.S. Gov't, P.H.S.; Research Support, Non-U.S. Gov't |
| Journal Info: | Publisher: New York Academy of Sciences Country of Publication: United States NLM ID: 7506858 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1749-6632 (Electronic) Linking ISSN: 00778923 NLM ISO Abbreviation: Ann N Y Acad Sci Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
| FullText | Links: – Type: pdflink Text: Availability: 0 |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 29090833 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Oner+ZG%22">Oner ZG</searchLink>; Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland.; Turkish Medicines and Medical Devices Agency, Ankara, Turkey.<br /><searchLink fieldCode="AU" term="%22Michel+SLJ%22">Michel SLJ</searchLink>; Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland.<br /><searchLink fieldCode="AU" term="%22Polli+JE%22">Polli JE</searchLink>; Department of Pharmaceutical Sciences, University of Maryland, Baltimore, Maryland. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%227506858%22">Annals of the New York Academy of Sciences</searchLink> [Ann N Y Acad Sci] 2017 Nov; Vol. 1407 (1), pp. 26-38. <i>Date of Electronic Publication: </i>2017 Nov 01. – Name: TypePub Label: Publication Type Group: TypPub Data: Journal Article; Review; Research Support, U.S. Gov't, P.H.S.; Research Support, Non-U.S. Gov't – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22New+York+Academy+of+Sciences%22">New York Academy of Sciences </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>7506858 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1749-6632 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2200778923%22">00778923 </searchLink><i>NLM ISO Abbreviation: </i>Ann N Y Acad Sci <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=29090833 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1111/nyas.13505 Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 26 Titles: – TitleFull: Equivalence and regulatory approaches of nonbiological complex drug products across the United States, the European Union, and Turkey. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Oner ZG – PersonEntity: Name: NameFull: Michel SLJ – PersonEntity: Name: NameFull: Polli JE IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 11 Text: 2017 Nov Type: published Y: 2017 Identifiers: – Type: issn-electronic Value: 1749-6632 Numbering: – Type: volume Value: 1407 – Type: issue Value: 1 Titles: – TitleFull: Annals of the New York Academy of Sciences Type: main |
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