Patrick Marroum
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View article: Assessment of Telisotuzumab Vedotin Drug–Drug Interaction Potential Using Physiologically‐Based Pharmacokinetic Modeling and Simulations
Assessment of Telisotuzumab Vedotin Drug–Drug Interaction Potential Using Physiologically‐Based Pharmacokinetic Modeling and Simulations Open
Telisotuzumab vedotin (Teliso‐V; ABBV‐399) is an antibody‐drug conjugate (ADC) comprised of the c‐Met targeting antibody telisotuzumab (ABT‐700) conjugated to the potent cytotoxic monomethyl auristatin E (MMAE). Teliso‐V has been evaluated…
View article: Model‐Informed Paradigm in Drug Development—An End‐To‐End Case Study From Upadacitinib Development
Model‐Informed Paradigm in Drug Development—An End‐To‐End Case Study From Upadacitinib Development Open
Model‐informed drug development (MIDD) entails applying quantitative approaches to assist with decision‐making during drug development and has been used for dose optimization, to inform clinical trial design, and to support clinical trial …
View article: Bioequivalence of Elagolix/Estradiol/Norethindrone Acetate Fixed‐Dose Combination Product: Phase 1 Results in Healthy Pre‐ and Postmenopausal Women
Bioequivalence of Elagolix/Estradiol/Norethindrone Acetate Fixed‐Dose Combination Product: Phase 1 Results in Healthy Pre‐ and Postmenopausal Women Open
Fixed‐dose combination (FDC) therapies can enhance patient convenience and adherence to prescribed treatment regimens. Elagolix is a novel oral gonadotropin‐releasing hormone receptor antagonist approved for management of moderate to sever…
View article: Clinical Bridging From Prefilled Syringe to On-body Injector for Risankizumab in Crohn's Disease
Clinical Bridging From Prefilled Syringe to On-body Injector for Risankizumab in Crohn's Disease Open
These results supported the risankizumab OBI presentation approval in CD.
View article: Evaluation of US Food and Drug Administration Drug Label Recommendations for Coadministration of Antivirals and Acid‐Reducing Agents
Evaluation of US Food and Drug Administration Drug Label Recommendations for Coadministration of Antivirals and Acid‐Reducing Agents Open
Coadministration with acid‐reducing agents (ARAs), including proton pump inhibitors (PPIs), histamine H 2 ‐receptor antagonists (H 2 blockers), and antacids has been demonstrated to reduce antiviral exposure and efficacy. Therefore, it is …
View article: Physiologically based pharmacokinetic modeling and simulations to inform dissolution specifications and clinical relevance of release rates on elagolix exposure
Physiologically based pharmacokinetic modeling and simulations to inform dissolution specifications and clinical relevance of release rates on elagolix exposure Open
The aim of this analysis was to use a physiologically based pharmacokinetic (PBPK) model to predict the impact of changes in dissolution rates on elagolix exposures and define clinically relevant acceptance criteria for dissolution. Varyin…
View article: Utility of Modeling and Simulation Approach to Support the Clinical Relevance of Dissolution Specifications: a Case Study from Upadacitinib Development
Utility of Modeling and Simulation Approach to Support the Clinical Relevance of Dissolution Specifications: a Case Study from Upadacitinib Development Open
Dissolution specifications are often essential in assuring the quality and consistency of therapeutic benefits of drug lots released to the market as in vitro dissolution is often considered to be a surrogate for bioavailability. Despite t…
View article: Accelerating Drug Development in Pediatric Oncology With the Clinical Pharmacology Storehouse
Accelerating Drug Development in Pediatric Oncology With the Clinical Pharmacology Storehouse Open
Pediatric drug development is a challenging process due to the rarity of the population, the need to meet regulatory requirements across the globe, the associated uncertainty in extrapolating data from adults, the paucity of validated biom…
View article: Pharmacokinetics of Upadacitinib With the Clinical Regimens of the Extended‐Release Formulation Utilized in Rheumatoid Arthritis Phase 3 Trials
Pharmacokinetics of Upadacitinib With the Clinical Regimens of the Extended‐Release Formulation Utilized in Rheumatoid Arthritis Phase 3 Trials Open
Upadacitinib is a Janus kinase 1 inhibitor under development for the treatment of several inflammatory disorders including rheumatoid arthritis (RA). Upadacitinib was administered in the phase 2 RA trials primarily as twice‐daily regimens …