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Future directions in drug-drug interaction evaluations: Industry perspective on the ICH M12 guidance.

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Title: Future directions in drug-drug interaction evaluations: Industry perspective on the ICH M12 guidance.
Authors: Umehara K; Roche Pharmaceutical Research and Early Development, Roche Innovation Center, F. Hoffmann-La Roche Ltd., Basel, Switzerland. Electronic address: kenichi.umehara@roche.com., Harrell A; Bristol Myers Squibb, Pharmaceutical Candidate Optimisation, Lawrenceville, NJ, USA., Prakash C; DMPK/Clinical Pharmacology, Agios, Cambridge, MA, USA., Hilgendorf C; DMPK, Early Research and Development Cardiovascular, Renal and Metabolism BioPharmaceuticals RD, AstraZeneca, Gothenburg, Sweden., Ballard TE; Drug Metabolism, Pharmacokinetics and Modeling, Takeda Development Center Americas, Inc., Cambridge, MA, USA., Huth F; PK Sciences, BioMedical Research. Novartis, Basel, Switzerland., Badée J; PK Sciences, BioMedical Research. Novartis, Basel, Switzerland., Jiang L; Drug Metabolism and Pharmacokinetics, Vertex Pharmaceuticals, Inc., San Diego, CA, USA., Vourvahis M; Pfizer Inc., Research and Development, New York, NY, USA., Pajkovic N; Pharmacokinetics, Dynamics, Metabolism and Bioanalytics, Merck & Co. Inc., Rahway, NJ, USA., Parrott N; Roche Pharmaceutical Research and Early Development, Roche Innovation Center, F. Hoffmann-La Roche Ltd., Basel, Switzerland., Thakkar N; GSK, 1250 S Collegeville Road, Collegeville, PA, USA., Marroum P; Clinical Pharmacology, Abbvie, Bldg AP31, 1 North Waukegan Road, North Chicago, IL, USA., Laethem R; Clinical Pharmacology & DMPK, Alkermes, 900 Winter Street, Waltham, MA, USA., Xu S; Preclinical Sciences & Translational Safety, Johnson & Johnson Innovative Medicine, Spring House, PA, USA., Chen Y; Genentech Inc., South San Francisco, CA, USA.
Source: Drug metabolism and pharmacokinetics [Drug Metab Pharmacokinet] 2026 Feb; Vol. 66, pp. 101512. Date of Electronic Publication: 2025 Dec 12.
Publication Type: Journal Article; Review
Journal Info: Publisher: Elsevier Country of Publication: England NLM ID: 101164773 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1880-0920 (Electronic) Linking ISSN: 13474367 NLM ISO Abbreviation: Drug Metab Pharmacokinet Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Umehara+K%22">Umehara K</searchLink>; Roche Pharmaceutical Research and Early Development, Roche Innovation Center, F. Hoffmann-La Roche Ltd., Basel, Switzerland. Electronic address: kenichi.umehara@roche.com.<br /><searchLink fieldCode="AU" term="%22Harrell+A%22">Harrell A</searchLink>; Bristol Myers Squibb, Pharmaceutical Candidate Optimisation, Lawrenceville, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Prakash+C%22">Prakash C</searchLink>; DMPK/Clinical Pharmacology, Agios, Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Hilgendorf+C%22">Hilgendorf C</searchLink>; DMPK, Early Research and Development Cardiovascular, Renal and Metabolism BioPharmaceuticals RD, AstraZeneca, Gothenburg, Sweden.<br /><searchLink fieldCode="AU" term="%22Ballard+TE%22">Ballard TE</searchLink>; Drug Metabolism, Pharmacokinetics and Modeling, Takeda Development Center Americas, Inc., Cambridge, MA, USA.<br /><searchLink fieldCode="AU" term="%22Huth+F%22">Huth F</searchLink>; PK Sciences, BioMedical Research. Novartis, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Badée+J%22">Badée J</searchLink>; PK Sciences, BioMedical Research. Novartis, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Jiang+L%22">Jiang L</searchLink>; Drug Metabolism and Pharmacokinetics, Vertex Pharmaceuticals, Inc., San Diego, CA, USA.<br /><searchLink fieldCode="AU" term="%22Vourvahis+M%22">Vourvahis M</searchLink>; Pfizer Inc., Research and Development, New York, NY, USA.<br /><searchLink fieldCode="AU" term="%22Pajkovic+N%22">Pajkovic N</searchLink>; Pharmacokinetics, Dynamics, Metabolism and Bioanalytics, Merck & Co. Inc., Rahway, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Parrott+N%22">Parrott N</searchLink>; Roche Pharmaceutical Research and Early Development, Roche Innovation Center, F. Hoffmann-La Roche Ltd., Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Thakkar+N%22">Thakkar N</searchLink>; GSK, 1250 S Collegeville Road, Collegeville, PA, USA.<br /><searchLink fieldCode="AU" term="%22Marroum+P%22">Marroum P</searchLink>; Clinical Pharmacology, Abbvie, Bldg AP31, 1 North Waukegan Road, North Chicago, IL, USA.<br /><searchLink fieldCode="AU" term="%22Laethem+R%22">Laethem R</searchLink>; Clinical Pharmacology & DMPK, Alkermes, 900 Winter Street, Waltham, MA, USA.<br /><searchLink fieldCode="AU" term="%22Xu+S%22">Xu S</searchLink>; Preclinical Sciences & Translational Safety, Johnson & Johnson Innovative Medicine, Spring House, PA, USA.<br /><searchLink fieldCode="AU" term="%22Chen+Y%22">Chen Y</searchLink>; Genentech Inc., South San Francisco, CA, USA.
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              Text: 2026 Feb
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