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Can Mechanistic Static Models for Drug-Drug Interactions Support Regulatory Filing for Study Waivers and Label Recommendations?

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Title: Can Mechanistic Static Models for Drug-Drug Interactions Support Regulatory Filing for Study Waivers and Label Recommendations?
Authors: Gomez-Mantilla JD; Boehringer Ingelheim Pharma GmbH & Co. KG, TMCP Therapeutic Areas, Binger Str. 173, 55218, Ingelheim am Rhein, Germany., Huang F; TMCP, Boehringer Ingelheim, Ridgefield, USA., Peters SA; Boehringer Ingelheim Pharma GmbH & Co. KG, TMCP Therapeutic Areas, Binger Str. 173, 55218, Ingelheim am Rhein, Germany. sheila.peters@boehringer-ingelheim.com.
Source: Clinical pharmacokinetics [Clin Pharmacokinet] 2023 Mar; Vol. 62 (3), pp. 457-480. Date of Electronic Publication: 2023 Feb 08.
Publication Type: Review; Journal Article; Research Support, Non-U.S. Gov't
Journal Info: Publisher: Adis, part of Springer Science+Business Media Country of Publication: Switzerland NLM ID: 7606849 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-1926 (Electronic) Linking ISSN: 03125963 NLM ISO Abbreviation: Clin Pharmacokinet Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Can Mechanistic Static Models for Drug-Drug Interactions Support Regulatory Filing for Study Waivers and Label Recommendations?
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  Data: <searchLink fieldCode="AU" term="%22Gomez-Mantilla+JD%22">Gomez-Mantilla JD</searchLink>; Boehringer Ingelheim Pharma GmbH & Co. KG, TMCP Therapeutic Areas, Binger Str. 173, 55218, Ingelheim am Rhein, Germany.<br /><searchLink fieldCode="AU" term="%22Huang+F%22">Huang F</searchLink>; TMCP, Boehringer Ingelheim, Ridgefield, USA.<br /><searchLink fieldCode="AU" term="%22Peters+SA%22">Peters SA</searchLink>; Boehringer Ingelheim Pharma GmbH & Co. KG, TMCP Therapeutic Areas, Binger Str. 173, 55218, Ingelheim am Rhein, Germany. sheila.peters@boehringer-ingelheim.com.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Adis%2C+part+of+Springer+Science%2BBusiness+Media%22">Adis, part of Springer Science+Business Media </searchLink><i>Country of Publication: </i>Switzerland <i>NLM ID: </i>7606849 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1179-1926 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2203125963%22">03125963 </searchLink><i>NLM ISO Abbreviation: </i>Clin Pharmacokinet <i>Subsets: </i>MEDLINE
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        Value: 10.1007/s40262-022-01204-4
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        Text: English
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        StartPage: 457
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      – TitleFull: Can Mechanistic Static Models for Drug-Drug Interactions Support Regulatory Filing for Study Waivers and Label Recommendations?
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              Text: 2023 Mar
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