Development and validation of LC-MS/MS methods for the pharmacokinetic assessment of the PROTACs bavdeglutamide (ARV-110) and vepdegestrant (ARV-471).

Autor: Niessen J; Department of Pharmaceutical Biosciences, Translational Drug Discovery and Development, Uppsala University, Uppsala, Sweden., Nilsson JM; Department of Medicinal Chemistry, Analytical Pharmaceutical Chemistry, Uppsala University, Uppsala, Sweden., Peters K; Department of Pharmaceutical Biosciences, Translational Drug Discovery and Development, Uppsala University, Uppsala, Sweden., Indulkar A; AbbVie Research and Development, 1N Waukegan Road, North Chicago, IL, USA., Borchardt T; AbbVie Research and Development, 1N Waukegan Road, North Chicago, IL, USA., Koziolek M; Abbvie Deutschland GmbH & Co. KG, Small Molecule CMC Development, Knollstrasse, Ludwigshafen, Germany., Lennernäs H; Department of Pharmaceutical Biosciences, Translational Drug Discovery and Development, Uppsala University, Uppsala, Sweden., Dahlgren D; Department of Pharmaceutical Biosciences, Translational Drug Discovery and Development, Uppsala University, Uppsala, Sweden., Hedeland M; Department of Medicinal Chemistry, Analytical Pharmaceutical Chemistry, Uppsala University, Uppsala, Sweden. Electronic address: mikael.hedeland@ilk.uu.se.

Publikováno v: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2024 Oct 15; Vol. 249, pp. 116348. Date of Electronic Publication: 2024 Jul 09.

Melatonin mitigates chemotherapy-induced small intestinal atrophy in rats and reduces cytotoxicity in murine intestinal organoids.

Autor: Peters K; Department of Medical Cell Biology, Uppsala University, Uppsala, Sweden.; Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden., Lerma Clavero A; Department of Medical Cell Biology, Uppsala University, Uppsala, Sweden., Kullenberg F; Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden., Kopsida M; Department of Medical Cell Biology, Uppsala University, Uppsala, Sweden., Dahlgren D; Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden., Heindryckx F; Department of Medical Cell Biology, Uppsala University, Uppsala, Sweden., Lennernäs H; Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden., Sjöblom M; Department of Medical Cell Biology, Uppsala University, Uppsala, Sweden.

Publikováno v: PloS one [PLoS One] 2024 Sep 03; Vol. 19 (9), pp. e0307414. Date of Electronic Publication: 2024 Sep 03 (Print Publication: 2024).

Model-Based Interspecies Scaling for Predicting Human Pharmacokinetics of CB 4332, a Complement Factor I Protein.

Autor: Ayoun Alsoud R; Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden., Le Moan N; Catalyst Biosciences, South San Francisco, California, USA., Holten-Andersen L; Catalyst Biosciences, South San Francisco, California, USA., Knudsen T; Catalyst Biosciences, South San Francisco, California, USA., Lennernäs H; Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden., Simonsson USH; Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden. Electronic address: ulrika.simonsson@uu.se.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2024 Sep; Vol. 113 (9), pp. 2895-2903. Date of Electronic Publication: 2024 Jun 28.

Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.

Autor: Pepin X; Regulatory Affairs, Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States., Arora S; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium., Borges L; ANVISA, SIA Trecho 5́, Guara, Brasília, Federal District 71205-050, Brazil., Cano-Vega M; Drug Product Technologies, Amgen Inc., Thousand Oaks, California 91320-1799, United States., Carducci T; Analytical Commercialization Technology, Merck & Co., Inc., 126 E. Lincoln Ave., Rahway, New Jersey 07065, United States., Chatterjee P; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Chen G; Takeda Development Center Americas Inc., 300 Shire Way, Lexington, Massachusetts 02421, United States., Cristofoletti R; College of Pharmacy, University of Florida, 6550 Sanger Rd., Orlando, Florida 32827, United States., Dallmann A; Bayer HealthCare SAS, 59000 Lille, France, on behalf of Bayer AG, Pharmacometrics/Modeling and Simulation, Systems Pharmacology & Medicine, PBPK, Leverkusen, Germany., Delvadia P; Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Dressman J; Fraunhofer Institute of Translational Medicine and Pharmacology, Frankfurt am Main 60596, Germany., Fotaki N; University of Bath, Claverton Down, Bath BA2 7AY, United Kingdom., Gray E; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Heimbach T; Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey 07065, United States., Holte Ø; Norwegian Medical Products Agency, Oslo 0213, Norway., Kijima S; Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo 100-0013, Japan., Kotzagiorgis E; European Medicines Agency (EMA), Domenico Scarlattilaan 6, Amsterdam 1083 HS, The Netherlands., Lennernäs H; Translational Drug Discovery and Development, Department of Pharmaceutical Bioscience, Uppsala University, Uppsala 751 05, Sweden., Lindahl A; Swedish Medical Products Agency, Uppsala 752 37, Sweden., Loebenberg R; Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmontonton T6G 2E1, Canada., Mackie C; Janssen Pharmaceutica NV, Turnhoutseweg 30, 2340 Beerse, Belgium., Malamatari M; Medicines & Healthcare Products Regulatory Agency, 10 S Colonnade, London SW1W 9SZ, United Kingdom., McAllister M; Global Biopharmaceutics, Drug Product Design, Pfizer, Sandwich CT13 9NJ, United Kingdom., Mitra A; Clinical Pharmacology, Kura Oncology Inc., Boston, Massachusetts 02210, United States., 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., Mudie D; Global Research and Development, Small Molecules, Lonza, 63045 NE Corporate Pl., Bend, Oregon 97701, United States., Musuamba Tshinanu F; Belgian Federal Agency for Medicines and Health Products, Galileelaan 5/03, Brussel 1210, Belgium., Polli JE; School of Pharmacy, University of Maryland, Baltimore, Maryland 21201, United States., Rege B; Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States., Ren X; PK Sciences/Translational Medicine, BioMedical Research, Novartis, One Health Plaza, East Hanover, New Jersey 07936, United States., Rullo G; Regulatory CMC, AstraZeneca, 1 Medimmune Way, Gaithersburg, Maryland 20878, United States., Scherholz M; Pharmaceutical Development, Bristol Myers Squibb, Route 206 & Province Line Road, Princeton, New Jersey 08543, United States., Song I; Takeda Development Center Americas Inc., 300 Shire Way, Lexington, Massachusetts 02421, United States., Stillhart C; Pharmaceutical R&D, F. Hoffmann-La Roche Ltd., Basel 4070, Switzerland., Suarez-Sharp S; Regulatory Affairs, Simulations Plus Inc., 42505 10th Street West, Lancaster, California 93534-7059, United States., Tannergren C; Biopharmaceutics Science, New Modalities & Parenteral Product Development, Pharmaceutical Technology & Development, Operations, AstraZeneca, Gothenburg 431 50, Sweden., Tsakalozou E; Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland 20903-1058, United States., Veerasingham S; Pharmaceutical Drugs Directorate (PDD), Health Canada, 1600 Scott St., Ottawa K1A 0K9, Canada., Wagner C; Global Drug Product Development, Global CMC Development, the Healthcare Business of Merck KGaA, Darmstadt D-64293, Germany., Seo P; Office of Translational Science, Office of Clinical Pharmacology (OCP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), Silver Spring, Maryland 20903-1058, United States.

Publikováno v: Molecular pharmaceutics [Mol Pharm] 2024 Aug 05; Vol. 21 (8), pp. 3697-3731. Date of Electronic Publication: 2024 Jun 30.

Physiologically based pharmacokinetics modeling and transporter proteomics to predict systemic and local liver and muscle disposition of statins.

Autor: Prieto Garcia L; Department of Pharmaceutical Bioscience, Translational Drug Discovery and Development, Uppsala University, Uppsala, Sweden.; DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Vildhede A; DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Nordell P; DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Ahlström C; DMPK, Research and Early Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden., Montaser AB; School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland., Terasaki T; School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, Kuopio, Finland., Lennernäs H; Department of Pharmaceutical Bioscience, Translational Drug Discovery and Development, Uppsala University, Uppsala, Sweden., Sjögren E; Department of Pharmaceutical Bioscience, Translational Drug Discovery and Development, Uppsala University, Uppsala, Sweden.

Publikováno v: CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2024 Jun; Vol. 13 (6), pp. 1029-1043. Date of Electronic Publication: 2024 Apr 04.