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Streamlining Food Effect Assessment - Are Repeated Food Effect Studies Needed? An IQ Analysis.
Kesisoglou, Filippos; Basu, Sumit; Belubbi, Tejashree; Bransford, Philip; Chung, John; Dodd, Stephanie; Dolton, Michael; Heimbach, Tycho; Kulkarni, Priyanka; Lin, Wen; Moir, Andrea; Parrott, Neil; Pepin, Xavier; Ren, Xiaojun; Sharma, Pradeep; Stamatopoulos, Konstantinos; Tistaert, Christophe; Vaidhyanathan, Shruthi; Wagner, Christian; Riedmaier, Arian Emami.
Afiliación
  • 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.
  • Ren X; Regulatory Affairs, Simulations Plus, Lancaster, CA, USA.
  • Sharma P; Modeling & Simulation, PK Sciences, Novartis Institutes of Biomedical Research, East Hanover, New Jersey, USA.
  • Stamatopoulos K; Clinical Pharmacology and Quantitative Pharmacology, Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK.
  • Tistaert C; Biopharmaceutics, DPD, MDS, GSK, David Jack Centre, Park Road, Ware, SG12 0DP, Hertfordshire, UK.
  • Vaidhyanathan S; Pharmaceutical Sciences, Janssen Research & Development, Beerse, Belgium.
  • Wagner C; Drug Product Science and Technology, Bristol-Myers Squibb, New Brunswick, New Jersey, USA.
  • Riedmaier AE; Global Drug Product Development, Global CMC Development, the Healthcare Business of Merck KGaA, Darmstadt, Germany.
AAPS J ; 25(4): 60, 2023 06 15.
Article en En | MEDLINE | ID: mdl-37322223

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Interacciones Alimento-Droga / Modelos Biológicos Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Interacciones Alimento-Droga / Modelos Biológicos Tipo de estudio: Guideline Límite: Humans Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos