PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report.

Autor: Heimbach T; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States., Musuamba Tshinanu F; Belgian Federal Agency for Medicines and Health Products, Galileelaan 5/03, Brussels 1210, Belgium., Raines K; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Borges L; ANVISA, SIA Trecho 5 - Guará, Brasília, DF 71205-050, Brazil., Kijima S; Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo 100-0013, Japan., Malamatari M; Medicines & Healthcare Products Regulatory Agency, 10 S Colonnade, London SW1W 9SZ, U.K., Moody R; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Veerasingham S; Pharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott St, Ottawa, Ontario K1A 0K9, Canada., Seo P; Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Turner D; Certara Predictive Technologies, Level 2-Acero, Simcyp Ltd, 1 Concourse Way, Sheffield S1 2BJ, United Kingdom., Fang L; Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Stillhart C; Pharmaceutical R&D, F. Hoffmann-La Roche Ltd., Basel CH-4070, Switzerland., Bransford P; Data and Computational Sciences, Vertex Pharmaceuticals, Inc., Boston, Massachusetts 02210, United States., Ren X; PK Sciences/Translational Medicine, BioMedical Research, Novartis, One Health Plaza, East Hanover, New Jersey 07936, United States., Patel N; Certara Predictive Technologies, Level 2-Acero, Simcyp Ltd, 1 Concourse Way, Sheffield S1 2BJ, United Kingdom., Sperry D; Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana 46285, United States., Chen H; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Rostami-Hodjegan A; Certara Predictive Technologies, Level 2-Acero, Simcyp Ltd, 1 Concourse Way, Sheffield S1 2BJ, United Kingdom.; Centre for Applied Pharmacokinetic Research, University of Manchester, Stopford Building, Oxford Road, Manchester M139PT, U.K., Lukacova V; Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534, United States., Sun D; The University of Michigan, North Campus Research Complex (NCRC), 1600 Huron Parkway, Ann Arbor, Michigan 48109, United States., Nguefack JF; Head of Biopharmacy Team, Montpellier, Synthetics Platform, Global CMC, Sanofi, Paris 75008, France., Carducci T; Analytical Commercialization Technology, Merck & Co., Inc., 126 E. Lincoln Ave, Rahway, New Jersey 07065, United States., Grimstein M; Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Pepin X; Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534, United States., Jamei M; Certara Predictive Technologies, Level 2-Acero, Simcyp Ltd, 1 Concourse Way, Sheffield S1 2BJ, United Kingdom., Stamatopoulos K; Biopharmaceutics, DPD, MDS, GlaxoSmithKline, David Jack Centre, Park Road, Ware SG12 0DP, U.K., Li M; Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Sanghavi M; Certara Predictive Technologies, Level 2-Acero, Simcyp Ltd, 1 Concourse Way, Sheffield S1 2BJ, United Kingdom., Tannergren C; Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 43183, Sweden., Mandula H; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Zhao Z; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Ju TR; Analytical R&D, AbbVie Inc., 1 North Waukegan Road, North Chicago, Illinois 60064, United States., Wagner C; Global Drug Product Development, Global CMC Development, the Healthcare Business of Merck KGaA, Darmstadt 64293, Germany., Arora S; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium., Wang M; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States., Rullo G; Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States., Mitra A; Clinical Pharmacology, Kura Oncology Inc, Boston, Massachusetts 02210, United States., Kollipara S; Biopharmaceutics Group, Global Clinical Management, Integrated Product Development Organization (IPDO), Dr. Reddy's Laboratories Ltd., Bachupally, Medchal Malkajgiri District, Hyderabad, 500 090 Telangana, India., Chirumamilla SK; Certara Predictive Technologies, Level 2-Acero, Simcyp Ltd, 1 Concourse Way, Sheffield S1 2BJ, United Kingdom., Polli JE; School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States., Mackie C; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium.

Publikováno v: Molecular pharmaceutics [Mol Pharm] 2024 Nov 04; Vol. 21 (11), pp. 5353-5372. Date of Electronic Publication: 2024 Sep 30.

Understanding Discordance between In Vitro Dissolution, Local Gut and Systemic Bioequivalence of Budesonide in Healthy and Crohn's Disease Patients through PBPK Modeling.

Autor: Han C; Centre for Applied Pharmacokinetic Research (CAPKR), University of Manchester, Manchester M13 9PL, UK.; Pharmaron Inc., Beijing 100176, China., Sun T; Pharmaron Inc., Beijing 100176, China., Chirumamilla SK; Simcyp Division, Certara, Sheffield S1 2BJ, UK., Bois FY; Simcyp Division, Certara, Sheffield S1 2BJ, UK., Xu M; Pharmaron Inc., Beijing 100176, China., Rostami-Hodjegan A; Centre for Applied Pharmacokinetic Research (CAPKR), University of Manchester, Manchester M13 9PL, UK.; Simcyp Division, Certara, Sheffield S1 2BJ, UK.

Publikováno v: Pharmaceutics [Pharmaceutics] 2023 Aug 30; Vol. 15 (9). Date of Electronic Publication: 2023 Aug 30.

Mechanistic PBPK Modelling to Predict the Advantage of the Salt Form of a Drug When Dosed with Acid Reducing Agents.

Autor: Chirumamilla SK; Certara UK Limited, Simcyp Division, Level 2-Acero, Sheffield S1 2BJ, UK., Banala VT; Certara UK Limited, Simcyp Division, Level 2-Acero, Sheffield S1 2BJ, UK., Jamei M; Certara UK Limited, Simcyp Division, Level 2-Acero, Sheffield S1 2BJ, UK., Turner DB; Certara UK Limited, Simcyp Division, Level 2-Acero, Sheffield S1 2BJ, UK.

Publikováno v: Pharmaceutics [Pharmaceutics] 2021 Jul 29; Vol. 13 (8). Date of Electronic Publication: 2021 Jul 29.