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Streamlining Food Effect Assessment - Are Repeated Food Effect Studies Needed? An IQ Analysis.

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Title: Streamlining Food Effect Assessment - Are Repeated Food Effect Studies Needed? An IQ Analysis.
Authors: Kesisoglou F; Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ, USA. Filippos_kesisoglou@merck.com., Basu S; Clinical Pharmacology - Oncology, Novartis Institutes of Biomedical Research, East Hanover, New Jersey, USA., Belubbi T; Pharmaceutical Sciences, Roche Pharmaceutical Research and Early Development, Roche Innovation Center, Basel, Switzerland., Bransford P; Data & Computational Sciences, Vertex Pharmaceuticals, Boston, Massachusetts, USA., Chung J; Drug Product Technologies, Amgen Inc., Thousand Oaks, California, USA., Dodd S; Chemical & Pharmaceutical Profiling, Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, USA., Dolton M; Roche Products Pty Ltd, Millers Point, NSW, Australia., Heimbach T; Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ, USA., Kulkarni P; Takeda Pharmaceuticals International, Cambridge, Massachusetts, USA., Lin W; Pharmacokinetics and Drug Metabolism, Sanofi, Bridgewater, New Jersey, USA., Moir A; Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK., Parrott N; Pharmaceutical Sciences, Roche Pharmaceutical Research and Early Development, Roche Innovation Center, Basel, Switzerland., Pepin X; New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Charter Way, Macclesfield, SK10 2NA, UK.; Regulatory Affairs, Simulations Plus, Lancaster, CA, USA., Ren X; Modeling & Simulation, PK Sciences, Novartis Institutes of Biomedical Research, East Hanover, New Jersey, USA., Sharma P; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK., Stamatopoulos K; Biopharmaceutics, DPD, MDS, GSK, David Jack Centre, Park Road, Ware, SG12 0DP, Hertfordshire, UK., Tistaert C; Pharmaceutical Sciences, Janssen Research & Development, Beerse, Belgium., Vaidhyanathan S; Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, New Jersey, USA., Wagner C; Global Drug Product Development, Global CMC Development, the Healthcare Business of Merck KGaA, Darmstadt, Germany., Riedmaier AE; Certara, PBPK Consultancy, Princeton, New Jersey, USA.
Source: The AAPS journal [AAPS J] 2023 Jun 15; Vol. 25 (4), pp. 60. Date of Electronic Publication: 2023 Jun 15.
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
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  Data: Streamlining Food Effect Assessment - Are Repeated Food Effect Studies Needed? An IQ Analysis.
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  Data: <searchLink fieldCode="AU" term="%22Kesisoglou+F%22">Kesisoglou F</searchLink>; Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ, USA. Filippos_kesisoglou@merck.com.<br /><searchLink fieldCode="AU" term="%22Basu+S%22">Basu S</searchLink>; Clinical Pharmacology - Oncology, Novartis Institutes of Biomedical Research, East Hanover, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Belubbi+T%22">Belubbi T</searchLink>; Pharmaceutical Sciences, Roche Pharmaceutical Research and Early Development, Roche Innovation Center, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Bransford+P%22">Bransford P</searchLink>; Data & Computational Sciences, Vertex Pharmaceuticals, Boston, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Chung+J%22">Chung J</searchLink>; Drug Product Technologies, Amgen Inc., Thousand Oaks, California, USA.<br /><searchLink fieldCode="AU" term="%22Dodd+S%22">Dodd S</searchLink>; Chemical & Pharmaceutical Profiling, Novartis Institutes for Biomedical Research, Cambridge, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Dolton+M%22">Dolton M</searchLink>; Roche Products Pty Ltd, Millers Point, NSW, Australia.<br /><searchLink fieldCode="AU" term="%22Heimbach+T%22">Heimbach T</searchLink>; Pharmaceutical Sciences, Merck & Co., Inc., Rahway, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Kulkarni+P%22">Kulkarni P</searchLink>; Takeda Pharmaceuticals International, Cambridge, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Lin+W%22">Lin W</searchLink>; Pharmacokinetics and Drug Metabolism, Sanofi, Bridgewater, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Moir+A%22">Moir A</searchLink>; Oral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Macclesfield, UK.<br /><searchLink fieldCode="AU" term="%22Parrott+N%22">Parrott N</searchLink>; Pharmaceutical Sciences, Roche Pharmaceutical Research and Early Development, Roche Innovation Center, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Pepin+X%22">Pepin X</searchLink>; New Modalities and Parenteral Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Charter Way, Macclesfield, SK10 2NA, UK.; Regulatory Affairs, Simulations Plus, Lancaster, CA, USA.<br /><searchLink fieldCode="AU" term="%22Ren+X%22">Ren X</searchLink>; Modeling & Simulation, PK Sciences, Novartis Institutes of Biomedical Research, East Hanover, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Sharma+P%22">Sharma P</searchLink>; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK.<br /><searchLink fieldCode="AU" term="%22Stamatopoulos+K%22">Stamatopoulos K</searchLink>; Biopharmaceutics, DPD, MDS, GSK, David Jack Centre, Park Road, Ware, SG12 0DP, Hertfordshire, UK.<br /><searchLink fieldCode="AU" term="%22Tistaert+C%22">Tistaert C</searchLink>; Pharmaceutical Sciences, Janssen Research & Development, Beerse, Belgium.<br /><searchLink fieldCode="AU" term="%22Vaidhyanathan+S%22">Vaidhyanathan S</searchLink>; Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, New Jersey, USA.<br /><searchLink fieldCode="AU" term="%22Wagner+C%22">Wagner C</searchLink>; Global Drug Product Development, Global CMC Development, the Healthcare Business of Merck KGaA, Darmstadt, Germany.<br /><searchLink fieldCode="AU" term="%22Riedmaier+AE%22">Riedmaier AE</searchLink>; Certara, PBPK Consultancy, Princeton, New Jersey, USA.
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