Physiologically-based pharmacokinetic modelling in sepsis: A tool to elucidate how pathophysiology affects meropenem pharmacokinetics.

Autor: Bahnasawy SM; Department of Pharmacy, Uppsala University, Uppsala, Sweden., Parrott NJ; Pharmaceutical Sciences, Roche Pharma Research and Early Development, Roche Innovation Centre Basel, Basel, Switzerland., Gijsen M; Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium; Pharmacy Department, University Hospitals Leuven, Leuven, Belgium., Spriet I; Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium; Pharmacy Department, University Hospitals Leuven, Leuven, Belgium., Friberg LE; Department of Pharmacy, Uppsala University, Uppsala, Sweden., Nielsen EI; Department of Pharmacy, Uppsala University, Uppsala, Sweden. Electronic address: elisabet.nielsen@farmaci.uu.se.

Publikováno v: International journal of antimicrobial agents [Int J Antimicrob Agents] 2024 Sep 28; Vol. 64 (6), pp. 107352. Date of Electronic Publication: 2024 Sep 28.

Mechanistic Modeling of In Vitro Biopharmaceutic Data for a Weak Acid Drug: A Pathway Towards Deriving Fundamental Parameters for Physiologically Based Biopharmaceutic Modeling.

Autor: Kowthavarapu VK; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics Lake Nona (Orlando), College of Pharmacy, University of Florida, 6550 Sanger Road, Office 467, Orlando, Florida, 32827, USA., Charbe NB; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics Lake Nona (Orlando), College of Pharmacy, University of Florida, 6550 Sanger Road, Office 467, Orlando, Florida, 32827, USA., Gupta C; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics Lake Nona (Orlando), College of Pharmacy, University of Florida, 6550 Sanger Road, Office 467, Orlando, Florida, 32827, USA., Iakovleva T; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics Lake Nona (Orlando), College of Pharmacy, University of Florida, 6550 Sanger Road, Office 467, Orlando, Florida, 32827, USA., Stillhart C; Pharmaceutical Research & Development, Formulation & Process Development, F. Hoffmann-La Roche Ltd., 4070, Basel, Switzerland., Parrott NJ; Pharmaceutical Research & Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd., 4070, Basel, Switzerland., Schmidt S; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics Lake Nona (Orlando), College of Pharmacy, University of Florida, 6550 Sanger Road, Office 467, Orlando, Florida, 32827, USA., Cristofoletti R; Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics Lake Nona (Orlando), College of Pharmacy, University of Florida, 6550 Sanger Road, Office 467, Orlando, Florida, 32827, USA. rcristofoletti@ufl.edu.

Publikováno v: The AAPS journal [AAPS J] 2024 Apr 04; Vol. 26 (3), pp. 44. Date of Electronic Publication: 2024 Apr 04.

Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report.

Autor: Al Shoyaib A; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Maryland, Silver Spring, USA., Riedmaier AE; Bristol Myers Squibb, Princeton, New Jersey, USA., Kumar A; Amneal Pharmaceuticals, Bridgewater, New Jersey, USA., Roy P; Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Parrott NJ; Research Innovation Center Basel, Roche, Basel, Switzerland., Fang L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Maryland, Silver Spring, USA., Tampal N; Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Yang Y; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Jereb R; Sandoz Development Center, Clinical Development, Sandoz, Slovenia., Zhao L; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Maryland, Silver Spring, USA., Wu F; Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Maryland, Silver Spring, USA.

Publikováno v: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2023 May; Vol. 12 (5), pp. 610-618. Date of Electronic Publication: 2023 Jan 16.

Perspectives from the Innovation and Quality Consortium Induction Working Group on Factors Impacting Clinical Drug-Drug Interactions Resulting from Induction: Focus on Cytochrome 3A Substrates.

Autor: Ramsden D; Alnylam Pharmaceuticals, Cambridge, Massachusetts (D.R.); Vertex Pharmaceuticals, Boston, Massachusetts (C.F., N.H., S.R.); Genentech, South San Francisco, California (J.R.K.); Eli Lilly and Company, Indianapolis, Indiana (M.M.); Roche Innovation Center, Basel, Switzerland (N.J.P.); and Merck & Co., Inc., Kenilworth, New Jersey (D.T.) dramsden@alnylam.com., Fung C; Alnylam Pharmaceuticals, Cambridge, Massachusetts (D.R.); Vertex Pharmaceuticals, Boston, Massachusetts (C.F., N.H., S.R.); Genentech, South San Francisco, California (J.R.K.); Eli Lilly and Company, Indianapolis, Indiana (M.M.); Roche Innovation Center, Basel, Switzerland (N.J.P.); and Merck & Co., Inc., Kenilworth, New Jersey (D.T.)., Hariparsad N; Alnylam Pharmaceuticals, Cambridge, Massachusetts (D.R.); Vertex Pharmaceuticals, Boston, Massachusetts (C.F., N.H., S.R.); Genentech, South San Francisco, California (J.R.K.); Eli Lilly and Company, Indianapolis, Indiana (M.M.); Roche Innovation Center, Basel, Switzerland (N.J.P.); and Merck & Co., Inc., Kenilworth, New Jersey (D.T.)., Kenny JR; Alnylam Pharmaceuticals, Cambridge, Massachusetts (D.R.); Vertex Pharmaceuticals, Boston, Massachusetts (C.F., N.H., S.R.); Genentech, South San Francisco, California (J.R.K.); Eli Lilly and Company, Indianapolis, Indiana (M.M.); Roche Innovation Center, Basel, Switzerland (N.J.P.); and Merck & Co., Inc., Kenilworth, New Jersey (D.T.)., Mohutsky M; Alnylam Pharmaceuticals, Cambridge, Massachusetts (D.R.); Vertex Pharmaceuticals, Boston, Massachusetts (C.F., N.H., S.R.); Genentech, South San Francisco, California (J.R.K.); Eli Lilly and Company, Indianapolis, Indiana (M.M.); Roche Innovation Center, Basel, Switzerland (N.J.P.); and Merck & Co., Inc., Kenilworth, New Jersey (D.T.)., Parrott NJ; Alnylam Pharmaceuticals, Cambridge, Massachusetts (D.R.); Vertex Pharmaceuticals, Boston, Massachusetts (C.F., N.H., S.R.); Genentech, South San Francisco, California (J.R.K.); Eli Lilly and Company, Indianapolis, Indiana (M.M.); Roche Innovation Center, Basel, Switzerland (N.J.P.); and Merck & Co., Inc., Kenilworth, New Jersey (D.T.)., Robertson S; Alnylam Pharmaceuticals, Cambridge, Massachusetts (D.R.); Vertex Pharmaceuticals, Boston, Massachusetts (C.F., N.H., S.R.); Genentech, South San Francisco, California (J.R.K.); Eli Lilly and Company, Indianapolis, Indiana (M.M.); Roche Innovation Center, Basel, Switzerland (N.J.P.); and Merck & Co., Inc., Kenilworth, New Jersey (D.T.)., Tweedie DJ; Alnylam Pharmaceuticals, Cambridge, Massachusetts (D.R.); Vertex Pharmaceuticals, Boston, Massachusetts (C.F., N.H., S.R.); Genentech, South San Francisco, California (J.R.K.); Eli Lilly and Company, Indianapolis, Indiana (M.M.); Roche Innovation Center, Basel, Switzerland (N.J.P.); and Merck & Co., Inc., Kenilworth, New Jersey (D.T.).

Publikováno v: Drug metabolism and disposition: the biological fate of chemicals [Drug Metab Dispos] 2019 Oct; Vol. 47 (10), pp. 1206-1221. Date of Electronic Publication: 2019 Aug 22.

Advancing Predictions of Tissue and Intracellular Drug Concentrations Using In Vitro, Imaging and Physiologically Based Pharmacokinetic Modeling Approaches.

Autor: Guo Y; Investigational Drug Disposition, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana,, USA., Chu X; Department of Pharmacokinetics, Pharmacodynamics, and Drug Metabolism, Merck & Co., Inc., Kenilworth, New Jersey,, USA., Parrott NJ; Pharmaceutical Sciences, Pharmaceutical Research and Early Development, Roche Innovation Centre Basel, F. Hoffmann-La Roche Ltd., Basel, Switzerland., Brouwer KLR; Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina,, USA., Hsu V; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland,, USA., Nagar S; Department of Pharmaceutical Sciences, Temple University School of Pharmacy, Philadelphia, Pennsylvania,, USA., Matsson P; Department of Pharmacy, Uppsala University, Uppsala, Sweden., Sharma P; Safety and ADME Translational Sciences, Drug Safety and Metabolism, IMED Biotech Unit, AstraZeneca R&D, Cambridge, UK., Snoeys J; Department of Pharmacokinetics, Dynamics, and Metabolism, Janssen R&D, Beerse, Belgium., Sugiyama Y; Sugiyama Laboratory, RIKEN Innovation Center, RIKEN Research Cluster for Innovation, Yokohama, Japan., Tatosian D; Department of Pharmacokinetics, Pharmacodynamics, and Drug Metabolism, Merck & Co., Inc., Kenilworth, New Jersey,, USA., Unadkat JD; Department of Pharmaceutics, University of Washington, Seattle, Washington,, USA., Huang SM; Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland,, USA., Galetin A; Centre for Applied Pharmacokinetic Research, School of Health Sciences, The University of Manchester, Manchester, UK.

Publikováno v: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2018 Nov; Vol. 104 (5), pp. 865-889. Date of Electronic Publication: 2018 Sep 12.