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Clinical Pharmacology and Therapeutics|November 20, 2023
Creating a Roadmap to Quantitative Systems Pharmacology-Informed Rare Disease Drug Development: A Workshop ReportJane P F Bai, Audra L Stinchcomb, Jie Wang, et al.Clinical Pharmacology and Therapeutics|November 16, 2023
Nutrimetric Validation of Solanidine as Dietary-Derived CYP2D6 Activity Marker In VivoJulian Peter Müller, Jens Sarömba, Patrick Ziegler, et al.Clinical Pharmacology and Therapeutics|November 15, 2023
Prediction of CYP Down Regulation after Tusamitamab Ravtansine Administration (a DM4-Conjugate), Based on an In Vitro-In Vivo Extrapolation ApproachClemence Pouzin, Donato Teutonico, Nathalie Fagniez, et al.Clinical Pharmacology and Therapeutics|November 13, 2023
A Nomogram to Predict Severe Toxicity in DPYD Wild-Type Patients Treated With Capecitabine-Based Anticancer RegimensJonathan E Knikman, Marta Lopez-Yurda, Didier Meulendijks, et al.Clinical Pharmacology and Therapeutics|November 10, 2023
Virtual Patient Simulation Using Copula ModelingLaura B Zwep, Tingjie Guo, Thomas Nagler, et al.Clinical Pharmacology and Therapeutics|November 13, 2023
Population Dose-Response-Time Analysis of Itch Reduction and Patient-Reported Tolerability Supports Phase III Dose Selection for LinerixibatFernando Carreño, Eleni Karatza, Rashmi Mehta, et al.Clinical Pharmacology and Therapeutics|September 13, 2023
ICH S7B In Vitro Assays Do Not Address Mechanisms of QTC Prolongation for Peptides and Proteins - Data in Support of Not Needing Dedicated QTC StudiesWendy W Wu, Moran Choe, Lars Johannesen, et al.Clinical Pharmacology and Therapeutics|August 9, 2023
Physiologically-Based Pharmacokinetic Modeling for Drug Dosing in Pediatric Patients: A Tutorial for a Pragmatic Approach in Clinical CareJoyce E M van der Heijden, Jolien J M Freriksen, Marika A de Hoop-Sommen, et al.Clinical Pharmacology and Therapeutics|August 10, 2023
TRPA1 Antagonist LY3526318 Inhibits the Cinnamaldehyde-Evoked Dermal Blood Flow Increase: Translational Proof of PharmacologyDorien Bamps, Anthony James Blockeel, Erwin Dreesen, et al.Clinical Pharmacology and Therapeutics|August 8, 2023
SURF: A Screening Tool (for Sponsors) to Evaluate Whether Using Real-World Data to Support an Effectiveness Claim in an FDA Application Has Regulatory FeasibilityUlka B Campbell, Nicholaas Honig, Nicolle M GattoPageof 940