General clinical and methodological considerations on the extrapolation of pharmacokinetics and optimization of study protocols for small molecules and monoclonal antibodies in children

Autor: Bouazza, N., Dokoumetzidis, A., Knibbe, C.A.J., Wildt, S.N. de, Ambery, C., Cock, P.A. de, Gasthuys, E., Foissac, F., Urien, S., Hamberg, A.K., Poggesi, I., Zhao, W., Vermeulen, A., Standing, J.F., Tréluyer, J.M.

Publikováno v: British Journal of Clinical Pharmacology, 88(12), 4985-4996. Wiley-Blackwell Publishing Ltd
British Journal of Clinical Pharmacology, 88, 12, pp. 4985-4996
British Journal of Clinical Pharmacology, 88, 4985-4996
British Journal of Clinical Pharmacology, 88(12), 4985-4996. WILEY

Contains fulltext : 287159.pdf (Publisher’s version ) (Closed access) Pharmacometric modelling plays a key role in both the design and analysis of regulatory trials in paediatric drug development. Studies in adults provide a rich source of data to

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bf938c0b697551178f234f049494a369
https://doi.org/10.1111/bcp.15571

Joint longitudinal model-based meta-analysis of FEV 1 and exacerbation rate in randomized COPD trials.

Autor: Llanos-Paez C; Department of Pharmacy, Uppsala University, Uppsala, Sweden., Ambery C; Clinical Pharmacology Modelling and Simulation, GSK, London, UK., Yang S; Clinical Pharmacology Modelling and Simulation, GSK, London, UK., Beerahee M; Clinical Pharmacology Modelling and Simulation, GSK, London, UK., Plan EL; Department of Pharmacy, Uppsala University, Uppsala, Sweden., Karlsson MO; Department of Pharmacy, Uppsala University, Uppsala, Sweden. mats.karlsson@farmaci.uu.se.; Department of Pharmacy, Uppsala University, BMC, Box 580, 751 23, Uppsala, Sweden. mats.karlsson@farmaci.uu.se.

Publikováno v: Journal of pharmacokinetics and pharmacodynamics [J Pharmacokinet Pharmacodyn] 2023 Aug; Vol. 50 (4), pp. 297-314. Date of Electronic Publication: 2023 Mar 22.

Negative Food Effect of Danirixin: Use of PBPK Modelling to Explore the Effect of Formulation and Meal Type on Clinical PK.

Autor: Lloyd RS; Medicinal Science and Technology, GlaxoSmithKline R&D, Park Road, Hertfordshire, UK., Hingle MI; Medicinal Science and Technology, GlaxoSmithKline R&D, Park Road, Hertfordshire, UK., Bloomer JC; Medicinal Science and Technology, GlaxoSmithKline R&D, Park Road, Hertfordshire, UK., Charles SJ; Medicinal Science and Technology, GlaxoSmithKline R&D, Park Road, Hertfordshire, UK., Butler JM; Medicinal Science and Technology, GlaxoSmithKline R&D, Park Road, Hertfordshire, UK., Paul A; Medicinal Science and Technology, GlaxoSmithKline R&D, Park Road, Hertfordshire, UK., Zhu X; Medicinal Science and Technology, GlaxoSmithKline R&D, Collegeville, Pennsylvania, USA., Miller B; Respiratory Therapy Area Unit, GlaxoSmithKline R&D, King of Prussia, Pennsylvania, USA., D'Amico D; Respiratory Therapy Area Unit, GlaxoSmithKline R&D, King of Prussia, Pennsylvania, USA., Donald A; Respiratory Therapy Area Unit, GlaxoSmithKline R&D, King of Prussia, Pennsylvania, USA., Tal-Singer R; Medical Innovation, GlaxoSmithKline R&D, Collegeville, Pennsylvania, USA., Ambery C; Clinical Pharmacology and Modelling Simulation, GlaxoSmithKline R&D, 980 Great West Road, TW8 9GS, Brentford, UK. Claire.l.ambery@gsk.com.

Publikováno v: Pharmaceutical research [Pharm Res] 2020 Oct 29; Vol. 37 (12), pp. 233. Date of Electronic Publication: 2020 Oct 29.

Improved Decision-Making Confidence Using Item-Based Pharmacometric Model: Illustration with a Phase II Placebo-Controlled Trial.

Autor: Llanos-Paez C; Department of Pharmacy, Uppsala University, Box 580, 751 23, Uppsala, Sweden., Ambery C; Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline plc, London, UK., Yang S; Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline plc, London, UK., Tabberer M; Patient Centred Outcomes: Value Evidence and Outcomes, GlaxoSmithKline plc, Brentford, Middlesex, UK., Beerahee M; Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline plc, London, UK., Plan EL; Department of Pharmacy, Uppsala University, Box 580, 751 23, Uppsala, Sweden., Karlsson MO; Department of Pharmacy, Uppsala University, Box 580, 751 23, Uppsala, Sweden. mats.karlsson@farmaci.uu.se.

Publikováno v: The AAPS journal [AAPS J] 2021 Jun 02; Vol. 23 (4), pp. 79. Date of Electronic Publication: 2021 Jun 02.

CXCR2 antagonist for patients with chronic obstructive pulmonary disease with chronic mucus hypersecretion: a phase 2b trial.

Autor: Lazaar AL; GSK, Collegeville, PA, USA. aili.l.lazaar@gsk.com., Miller BE; GSK, Collegeville, PA, USA., Donald AC; GSK, Collegeville, PA, USA., Keeley T; GSK - Stockley Park, Uxbridge, UK., Ambery C; GSK - Stockley Park, Uxbridge, UK., Russell J; GSK, Collegeville, PA, USA., Watz H; Pulmonary Research Institute Lungen Clinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL) -, Grosshansdorf, Germany., Tal-Singer R; GSK, Collegeville, PA, USA.

Publikováno v: Respiratory research [Respir Res] 2020 Jun 12; Vol. 21 (1), pp. 149. Date of Electronic Publication: 2020 Jun 12.