Streamlining Food Effect Assessment - Are Repeated Food Effect Studies Needed? An IQ Analysis.
Saved in:
| 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 |
| Database: | MEDLINE Ultimate |
|
Full text is not displayed to guests.
Login for full access.
|
|
| ISSN: | 1550-7416 |
|---|---|
| DOI: | 10.1208/s12248-023-00822-5 |
