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? |
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| 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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| ISSN: | 1179-1926 |
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| DOI: | 10.1007/s40262-022-01204-4 |
