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Ensuring Medical Product Patient Access Through Application of Recently Improved Global Chemistry, Manufacturing and Control Regulatory Frameworks: A Case Study Utilizing a Multi-Product PACMP.

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Title: Ensuring Medical Product Patient Access Through Application of Recently Improved Global Chemistry, Manufacturing and Control Regulatory Frameworks: A Case Study Utilizing a Multi-Product PACMP.
Authors: Dave SK; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk Service Centre India Private Limited, Bangalore, India., Ørting C; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk A/S, Søborg, Denmark., Roberts SW; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk A/S, Søborg, Denmark. OSRB@novonordisk.com.
Source: The AAPS journal [AAPS J] 2025 Oct 03; Vol. 27 (6), pp. 151. Date of Electronic Publication: 2025 Oct 03.
Publication Type: Journal Article
Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Ensuring Medical Product Patient Access Through Application of Recently Improved Global Chemistry, Manufacturing and Control Regulatory Frameworks: A Case Study Utilizing a Multi-Product PACMP.
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  Data: <searchLink fieldCode="AU" term="%22Dave+SK%22">Dave SK</searchLink>; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk Service Centre India Private Limited, Bangalore, India.<br /><searchLink fieldCode="AU" term="%22Ørting+C%22">Ørting C</searchLink>; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk A/S, Søborg, Denmark.<br /><searchLink fieldCode="AU" term="%22Roberts+SW%22">Roberts SW</searchLink>; Regulatory Affairs, Chemistry, Manufacturing and Controls, Novo Nordisk A/S, Søborg, Denmark. OSRB@novonordisk.com.
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  Data: <searchLink fieldCode="JN" term="%22101223209%22">The AAPS journal</searchLink> [AAPS J] 2025 Oct 03; Vol. 27 (6), pp. 151. <i>Date of Electronic Publication: </i>2025 Oct 03.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22American+Association+of+Pharmaceutical+Scientists%22">American Association of Pharmaceutical Scientists </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101223209 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1550-7416 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2215507416%22">15507416 </searchLink><i>NLM ISO Abbreviation: </i>AAPS J <i>Subsets: </i>MEDLINE
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        Value: 10.1208/s12248-025-01133-7
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        StartPage: 151
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      – TitleFull: Ensuring Medical Product Patient Access Through Application of Recently Improved Global Chemistry, Manufacturing and Control Regulatory Frameworks: A Case Study Utilizing a Multi-Product PACMP.
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            – D: 03
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              Text: 2025 Oct 03
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