Works in Clinical Pharmacology & Therapeutics, 2024, Vol 116, Issue 5

Results: 26

ASCPT News.

Published in:: Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1158, doi. 10.1002/cpt.3437
Publication type:: Article

Real‐World Evidence in Regulatory Decision Making: Time for Evidence Integration.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1153, doi. 10.1002/cpt.3444

By:

Miksad, Rebecca A.

Publication type:

Article

HIGHLIGHTED ARTICLES.

Published in:: Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1156, doi. 10.1002/cpt.3435
Publication type:: Article

In This Issue.

Published in:: Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1151, doi. 10.1002/cpt.3434
Publication type:: Article

A Comparative Clinical Pharmacology Analysis of FDA‐Approved Targeted Covalent Inhibitors vs. Reversible Inhibitors in Oncology.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1198, doi. 10.1002/cpt.3390

By:

Ngo, Huy X.;
Wen, Yue Winnie;
Pisupati, Swathi;
Huang, Weize;
Mandlekar, Sandhya

Publication type:

Article

Item Response Theory Quantifies the Relationship Between Improvements in Serum Phosphate and Patient‐Reported Outcomes in Adults With X‐Linked Hypophosphatemia.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1343, doi. 10.1002/cpt.3406

By:

Mehta, Krina;
Gosselin, Nathalie H.;
Insogna, Karl;
Barriere, Olivier;
Quattrocchi, Emilia;
Hruska, Matthew W.;
Marsteller, Douglas

Publication type:

Article

Exposure Matching‐Based Pediatric Dose Selection for Drugs with Renal Excretion – Lessons Learned from Pediatric Development of Direct Oral Anticoagulants.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1174, doi. 10.1002/cpt.3396

By:

Zou, Peng;
Leil, Tarek A.

Publication type:

Article

The Effect of Low‐Dose Colchicine on the Phenotype and Function of Neutrophils and Monocytes in Patients with Chronic Coronary Artery Disease: A Double‐Blind Randomized Placebo‐Controlled Cross‐Over Study.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1325, doi. 10.1002/cpt.3394

By:

Tercan, Helin;
van Broekhoven, Amber;
Bahrar, Harsh;
Opstal, Tjerk;
Cossins, Benjamin C.;
Rother, Nils;
Rodwell, Laura;
Bekkering, Siroon;
El Messaoudi, Saloua;
Riksen, Niels P.;
Cornel, Jan H.

Publication type:

Article

Congenital and Fetal Effects After Mifepristone Exposure and Continuation of Pregnancy: A Systematic Review.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1207, doi. 10.1002/cpt.3392

By:

Turner, Joseph V.;
Garratt, Deborah;
Barwick, Anna;
McLindon, Lucas A.;
Spark, M. Joy;
Smith, Angela

Publication type:

Article

A Phase 1 Assessment of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of (2R,6R)‐Hydroxynorketamine in Healthy Volunteers.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1314, doi. 10.1002/cpt.3391

By:

Raja, Shruti M.;
Guptill, Jeffrey T.;
Mack, Michelle;
Peterson, Marni;
Byard, Stephen;
Twieg, Robert;
Jordan, Lynn;
Rich, Natalie;
Castledine, Richard;
Bourne, Samuel;
Wilmshurst, Martin;
Oxendine, Sarah;
Avula, Satya G.C.;
Zuleta, Helen;
Quigley, Paul;
Lawson, Sheila;
McQuaker, Stephen J.;
Ahmadkhaniha, Reza;
Appelbaum, Lawrence G.;
Kowalski, Kevin

Publication type:

Article

Coproporphyrin‐I as a Selective OATP1B Biomarker Can Be Used to Delineate the Mechanisms of Complex Drug–Drug Interactions: Cedirogant Case Study.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1334, doi. 10.1002/cpt.3399

By:

Kikuchi, Ryota;
Qian, Yuli;
Badawi, Mohamed;
Savaryn, John P.;
Gannu, Shashikanth;
Eldred, Ann;
Hao, Shuai;
Salem, Ahmed Hamed;
Liu, Wei;
Klein, Cheri E.;
Mohamed, Mohamed‐Eslam F.

Publication type:

Article

Return to SENDer: The Submitted Electronic Data for Nonclinical Cardiovascular Studies is Not Facilitating Transparency, Translation or Innovation.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1164, doi. 10.1002/cpt.3389

By:

Abernathy, Matthew M.;
Best, Derek D.;
Leishman, Derek J.

Publication type:

Article

Evaluating the Effect of Estimating Renal Function With the CKD‐EPI 2021 Equation on the ABCD‐GENE Score for Clopidogrel Response Prediction.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1227, doi. 10.1002/cpt.3385

By:

AlSaeed, Maryam Jamal;
Thomas, Cameron D.;
Franchi, Francesco;
Keeley, Ellen C.;
Duarte, Julio D.;
Gong, Yan;
Rossi, Joseph S.;
Beitelshees, Amber L.;
Stouffer, George A.;
Lee, Craig R.;
Angiolillo, Dominick J.;
Cavallari, Larisa H.

Publication type:

Article

Ticagrelor modestly raises plasma riboflavin concentration in humans and inhibits riboflavin transport by BCRP and MRP4.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1222, doi. 10.1002/cpt.3384

By:

Deng, Feng;
Hämäläinen, Kreetta;
Lehtisalo, Minna;
Neuvonen, Mikko;
Niemi, Mikko

Publication type:

Article

Population Pharmacokinetic Modeling and Exposure–Response Analysis for the Antibody–Drug Conjugate Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Carcinoma.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1278, doi. 10.1002/cpt.3383

By:

Zuo, Peiying;
Bonate, Peter;
Garg, Amit;
Matsangou, Maria;
Tang, Mei

Publication type:

Article

Cannabidiol Increases Psychotropic Effects and Plasma Concentrations of Δ<sup>9</sup>‐Tetrahydrocannabinol Without Improving Its Analgesic Properties.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1289, doi. 10.1002/cpt.3381

By:

Gorbenko, Andriy A.;
Heuberger, Jules A.A.C.;
Klumpers, Linda E.;
de Kam, Marieke L.;
Strugala, Pamela K.;
de Visser, Saco J.;
Groeneveld, Geert J.

Publication type:

Article

Solanidine Metabolites as Diet‐Derived Biomarkers of CYP2D6‐Mediated Tamoxifen Metabolism in Breast Cancer Patients.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1269, doi. 10.1002/cpt.3380

By:

Medwid, Samantha;
Schwarz, Ute I.;
Choi, Yun‐Hee;
Keller, Denise;
Ross, Cameron;
Kim, Richard B.

Publication type:

Article

Disentangling Anti‐Tumor Response of Immunotherapy Combinations: A Physiologically Based Framework for V937 Oncolytic Virus and Pembrolizumab.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1304, doi. 10.1002/cpt.3379

By:

Sancho‐Araiz, Aymara;
Parra‐Guillen, Zinnia P.;
Troconiz, Iñaki F.;
Freshwater, Tomoko

Publication type:

Article

Pseudo‐Worsening of Kidney Function Due to Inhibition of Renal Creatinine Secretion: Quality of Information Provided in Prescribing Information/SmPC.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1259, doi. 10.1002/cpt.3374

By:

Sponfeldner, Michael I.;
Andrikyan, Wahram;
Maas, Renke;
Fromm, Martin F.

Publication type:

Article

Limitations Reported in Evaluating Effectiveness of Risk Minimization Measures in the EU during 2018–2021: A Qualitative Analysis of Industry‐Sponsored Post‐Authorization Safety Studies.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1252, doi. 10.1002/cpt.3369

By:

Grupstra, Renske J.;
Goedecke, Thomas;
Gardarsdottir, Helga

Publication type:

Article

Enhancing External Control Arm Analyses through Data Calibration and Hybrid Designs.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1168, doi. 10.1002/cpt.3364

By:

Schneeweiss, Sebastian

Publication type:

Article

Pharmacokinetics and Exposure–Response Analyses to Support Dose Selection of Upadacitinib in Crohn's Disease.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1240, doi. 10.1002/cpt.3359

By:

Bhatnagar, Sumit;
Schlachter, Louisa;
Eckert, Doerthe;
Stodtmann, Sven;
Liu, Wei;
Lacerda, Ana P.;
Mohamed, Mohamed‐Eslam F.

Publication type:

Article

Real‐World Evidence to Support EU Regulatory Decision Making—Results From a Pilot of Regulatory Use Cases.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1188, doi. 10.1002/cpt.3355

By:

Prilla, Stefanie;
Groeneveld, Sophie;
Pacurariu, Alexandra;
Restrepo‐Méndez, María Clara;
Verpillat, Patrice;
Torre, Carla;
Gartner, Christian;
Mol, Peter G. M.;
Naumann‐Winter, Frauke;
Breen, Kieran C.;
Gault, Nathalie;
Gross‐Martirosyan, Liana;
Benchetrit, Sylvie;
Aylward, Brian;
Stoyanova‐Beninska, Violeta;
O'Donovan, Maura;
Straus, Sabine;
Kjaer, Jesper;
Arlett, Peter

Publication type:

Article

Low Nirmatrelvir and Ritonavir Exposure through Breastmilk: Analyzing Milk Concentrations and Infant Risk.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1217, doi. 10.1002/cpt.3352

By:

Dai, Jean;
Fuquay, Taylor;
Huseman, Samuel;
Patel, Dhavalkumar;
Datta, Palika;
Krutsch, Kaytlin

Publication type:

Article

Pharmacokinetics, Mass Balance, Safety, and Tolerability of Obeldesivir in Healthy Participants.

Published in:

Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1231, doi. 10.1002/cpt.3337

By:

Anoshchenko, Olena;
Abdelghany, Mazin;
Lichtman, Amos;
Duan, Ran;
Chen, Henry;
Shaik, Naveed A.;
Peng, Chi‐Chi;
Yue, Qin;
Subramanian, Raju;
Hyland, Robert H.;
Davies, Santosh;
Castellanos, Keelin;
Mak, Lily;
Shen, Gong;
Xiao, Deqing;
Caro, Luzelena;
Winter, Helen;
Llewellyn, Joe;
Humeniuk, Rita

Publication type:

Article

Issue Information.

Published in:: Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 5, p. 1143, doi. 10.1002/cpt.2948
Publication type:: Article