Works matching IS 00099236 AND DT 2025 AND VI 117 AND IP 1

Results: 34

Highlighted Articles.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 14, doi. 10.1002/cpt.3490
Publication type:
Article
Correction to Beyond MABEL: An Integrative Approach to First in Human Dose Selection of Immunomodulators by the Health and Environmental Sciences Institute (HESI) Immuno‐Safety Technical Committee (ITC).
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 310, doi. 10.1002/cpt.3489
Publication type:
Article
In This Issue.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 9, doi. 10.1002/cpt.3488
Publication type:
Article
First‐in‐Human Dose Selection for T‐Cell Engaging Bispecific Antibodies.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 11, doi. 10.1002/cpt.3487
By:
- van der Graaf, Piet H.
Publication type:
Article
ASCPT News.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 16, doi. 10.1002/cpt.3486
Publication type:
Article
Correction to: Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Healthy Volunteers and Patients with Chronic Kidney Disease.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 309, doi. 10.1002/cpt.3483
Publication type:
Article
Narrow Therapeutic Index Drugs: FDA Experience, Views, and Operations.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 116, doi. 10.1002/cpt.3460
By:
- Donnelly, Mark;
- Fang, Lanyan;
- Madabushi, Rajanikanth;
- Zhu, Hao;
- Luke, Markham;
- Canterbury, Crystal;
- Lerman, Bruce;
- Kaur, Paramjeet;
- Patel, Devvrat;
- Sun, Wanjie;
- Schuirmann, Don;
- Dinsmore, Steven;
- Mehta, Mehul;
- Zhao, Liang
Publication type:
Article
Harnessing Pharmacogenomics in Clinical Research on Psychedelic‐Assisted Therapy.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 106, doi. 10.1002/cpt.3459
By:
- Halman, Andreas;
- Conyers, Rachel;
- Moore, Claire;
- Khatri, Dhrita;
- Sarris, Jerome;
- Perkins, Daniel
Publication type:
Article
Value of Pharmacogenetic Testing Assessed with Real‐World Drug Utilization and Genotype Data.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 278, doi. 10.1002/cpt.3458
By:
- Litonius, Kaisa;
- Kulla, Noora;
- Falkenbach, Petra;
- Kristiansson, Kati;
- Tarkiainen, E. Katriina;
- Ukkola‐Vuoti, Liisa;
- Cajanus, Kristiina;
- Korhonen, Mari;
- Khan, Sofia;
- Sistonen, Johanna;
- Orpana, Arto;
- Lindstedt, Mats;
- Nyrönen, Tommi;
- Perola, Markus;
- Turpeinen, Miia;
- Kytö, Ville;
- Tornio, Aleksi;
- Niemi, Mikko
Publication type:
Article
New Drug Development Strategy in Japan: Flexibility in Guideline Adherence.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 270, doi. 10.1002/cpt.3456
By:
- Kobayashi, Mihoko;
- Narukawa, Mamoru
Publication type:
Article
Prediction of Cardiac ATTR Depletion by NI006 (ALXN2220) Using Mechanistic PK/PD Modeling.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 261, doi. 10.1002/cpt.3455
By:
- Michalon, Aubin;
- Renaud, Lionel;
- Machacek, Matthias;
- Cortijo, Cédric;
- Udata, Chandrasekhar;
- Mercuri, Michele F.;
- Buller, Fabian;
- Hock, Christoph;
- Nitsch, Roger M.;
- Kahr, Peter C.;
- Grimm, Jan
Publication type:
Article
Sex‐Dependent Effects of CYP2D6 on the Pharmacokinetics of Berberine in Humans.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 250, doi. 10.1002/cpt.3454
By:
- Blöcher, Jonas A.;
- Meyer‐Tönnies, Marleen J.;
- Morof, Felix;
- Rönnpagel, Vincent;
- Bethmann, Jonas;
- Vollmer, Marcus;
- Engeli, Stefan;
- Tzvetkov, Mladen V.
Publication type:
Article
Correction to Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 289, doi. 10.1002/cpt.3453
Publication type:
Article
Reply to: "Questioning Conclusions and Statements on the German HTA System: A Critical Perspective".
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 24, doi. 10.1002/cpt.3452
By:
- Harnett, James;
- Heidt, Julien;
- Quek, Ruben G. W.;
- Walsh, Laura
Publication type:
Article
Pharmacokinetic, Safety, and Pharmacodynamic Profiles of Saroglitazar Magnesium in Cholestatic Cirrhosis With Hepatic Impairment and Participants With Renal Impairment.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 240, doi. 10.1002/cpt.3450
By:
- Vuppalanchi, Raj;
- Cruz, Mary M.;
- Momin, Taufik;
- Shaikh, Farheen;
- Swint, Kimberly;
- Patel, Harilal;
- Parmar, Deven
Publication type:
Article
Characteristics of Drugs from Non‐Global Companies for Hematologic Malignancies and Impact on Global Regulatory Approval.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 232, doi. 10.1002/cpt.3440
By:
- Matsuda, Kensuke;
- Nagai, Sumimasa;
- Sugimoto, Koichi
Publication type:
Article
Industry Perspective on First‐in‐Human and Clinical Pharmacology Strategies to Support Clinical Development of T‐Cell Engaging Bispecific Antibodies for Cancer Therapy.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 34, doi. 10.1002/cpt.3439
By:
- Nagaraja Shastri, Prathap;
- Shah, Nirav;
- Lechmann, Martin;
- Mody, Hardik;
- Retter, Marc W.;
- Zhu, Min;
- Li, Tommy;
- Wang, Jun;
- Shaik, Naveed;
- Zheng, Xirong;
- Ovacik, Meric;
- Hua, Fei;
- Jawa, Vibha;
- Boetsch, Christophe;
- Cao, Yanguang;
- Burke, John;
- Datta, Kaushik;
- Gadkar, Kapil;
- Upreti, Vijay;
- Betts, Alison
Publication type:
Article
An Innovative Approach to Optimize First‐In‐Human Minimal Anticipated Biological Effect Level Based Starting Dose in Oncology Trials for Bispecific T‐Cell Engagers: Experience from A Solid Tumor Bispecific T‐Cell Engager.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 225, doi. 10.1002/cpt.3431
By:
- Zhou, Di;
- Kischel, Roman;
- Stienen, Sabine;
- Townsley, Danielle;
- Sternjak, Alexander;
- Lutteropp, Michael;
- Bailis, Julie;
- Friedrich, Matthias;
- Rattel, Benno;
- Mehta, Khamir;
- Upreti, Vijay V.
Publication type:
Article
A User‐Driven Framework for Dose Selection in Pregnancy: Proof of Concept for Sertraline.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 214, doi. 10.1002/cpt.3429
By:
- Koldeweij, Charlotte;
- Dibbets, Caroline;
- Franklin, Bryony D.;
- Scheepers, Hubertina C. J.;
- de Wildt, Saskia N.
Publication type:
Article
Crossing the Chasm: How to Approach Translational Pharmacokinetic–Pharmacodynamic Modeling of Phage Dosing.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 94, doi. 10.1002/cpt.3426
By:
- Rao, Gauri G.;
- Vallé, Quentin;
- Mahadevan, Ramya;
- Sharma, Rajnikant;
- Barr, Jeremy J.;
- Van Tyne, Daria
Publication type:
Article
Population Pharmacokinetics and Exposure–Response Analysis of a Fixed‐Dose Combination of Ivermectin and Albendazole in Children, Adolescents, and Adults.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 203, doi. 10.1002/cpt.3424
By:
- Algorta, Jaime;
- Kepha, Stella;
- Krolewiecki, Alejandro;
- Li, Hanbin;
- Giang, Justin;
- Fleitas, Pedro;
- Mwandawiro, Charles;
- Muñoz, José
Publication type:
Article
A Pooled Population Pharmacokinetic Study of Oral and Intravenous Administration of Clavulanic Acid in Neonates and Infants: Targeting Effective Beta‐Lactamase Inhibition.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 193, doi. 10.1002/cpt.3423
By:
- Schouwenburg, Stef;
- Keij, Fleur M.;
- Tramper‐Stranders, Gerdien A.;
- Kornelisse, René F.;
- Reiss, Irwin K. M.;
- De Cock, Pieter A. J. G.;
- Dhont, Evelyn;
- Watt, Kevin M.;
- Muller, Anouk E.;
- Flint, Robert B.;
- Koch, Birgit C. P.;
- Allegaert, Karel;
- Preijers, Tim
Publication type:
Article
Population Pharmacokinetics of Trimethoprim/Sulfamethoxazole: Dosage Optimization for Patients with Renal Insufficiency or Receiving Continuous Renal Replacement Therapy.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 184, doi. 10.1002/cpt.3421
By:
- Leegwater, Emiel;
- Baidjoe, Lauren;
- Wilms, Erik B.;
- Visser, Leo G.;
- Touw, Daniel J.;
- de Winter, Brenda C. M.;
- de Boer, Mark G. J.;
- van Paassen, Judith;
- van den Berg, Charlotte H. S. B.;
- van Prehn, Joffrey;
- van Gelder, Teun;
- Moes, Dirk Jan A. R.
Publication type:
Article
Neuron‐Derived Extracellular Vesicles miRNA Profiles Identify Children Who Experience Adverse Events after Ketamine Administration for Procedural Sedation.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 174, doi. 10.1002/cpt.3420
By:
- Lucafò, Marianna;
- Bidoli, Carlotta;
- Franzin, Martina;
- Eitan, Erez;
- Rau, Sara;
- Amaddeo, Alessandro;
- Fachin, Alice;
- d'Adamo, Adamo Pio;
- Decorti, Giuliana;
- Stocco, Gabriele;
- Barbi, Egidio;
- Cozzi, Giorgio
Publication type:
Article
Prediction of the Intra‐T Lymphocyte Tacrolimus Concentration after Kidney Transplantation with Population Pharmacokinetic Modeling.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 162, doi. 10.1002/cpt.3419
By:
- Udomkarnjananun, Suwasin;
- Schagen, Maaike R.;
- Volarević, Helena;
- van de Velde, Daan;
- Dieterich, Marjolein;
- Matic, Maja;
- Baan, Carla C.;
- Reinders, Marlies E. J.;
- de Winter, Brenda C. M.;
- Hesselink, Dennis A.
Publication type:
Article
Partial Residual Plots as an Integrated Model Diagnostic Tool in Model‐Based Meta‐Analysis.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 153, doi. 10.1002/cpt.3418
By:
- Maringwa, John;
- Diderichsen, Paul Matthias;
- Valiathan, Chandni
Publication type:
Article
Effects of Sacubitril/Valsartan on Survival in Patients with Heart Failure and Significant Valvular Heart Disease.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 143, doi. 10.1002/cpt.3417
By:
- Lin, Donna Shu‐Han;
- Chao, Ying‐Ting;
- Chuang, Shu‐Lin;
- Lee, Jen‐Kuang;
- Lin, Ting‐Tse;
- Lin, Lung‐Chun;
- Huang, Kuan‐Chih;
- Hwang, Juey‐Jen
Publication type:
Article
Towards Preanalytical Best Practices for Liquid Biopsy Studies: A BLOODPAC Landscape Analysis.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 28, doi. 10.1002/cpt.3416
By:
- Lockwood, Christina M.;
- Merker, Jason D.;
- Bain, Elizabeth;
- Compton, Caroline;
- Grossman, Robert L.;
- Johann, Donald;
- Jones, Frederick;
- Jones, Gregory;
- Kreifels, Matthew;
- LeBlang, Suzanne;
- Lee, Jerry S.H.;
- Lyle, John;
- Martini, Jean‐Francois;
- Saunders, Lauren;
- Scher, Howard;
- Somiari, Stella;
- Stewart, Mark;
- Vinson, Jacob;
- Leiman, Lauren C.
Publication type:
Article
New Biomarkers for Renal Transporter‐Mediated Drug–Drug Interactions: Metabolomic Effects of Cimetidine, Probenecid, Verapamil, and Rifampin in Humans.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 130, doi. 10.1002/cpt.3414
By:
- Gessner, Arne;
- König, Jörg;
- Wenisch, Pia;
- Heinrich, Markus R.;
- Stopfer, Peter;
- Fromm, Martin F.;
- Müller, Fabian
Publication type:
Article
Comparative Analysis of Post‐Authorization Measures for Advanced Medicinal Products Authorized in the European Union and in the United States of America Between 2009 and 2023.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 73, doi. 10.1002/cpt.3410
By:
- Mandslay, Diana;
- Almeida, Diogo;
- Marques, Adriana;
- Rocha, João;
- Drafi, Frantisek;
- Sepodes, Bruno;
- Torre, Carla
Publication type:
Article
Questioning the Design of Non‐Inferiority Trials: The Strange Case for Therapeutic Drug Monitoring Absence in Phase III Trials.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 25, doi. 10.1002/cpt.3408
By:
- Lemaitre, Florian;
- Lalanne, Sébastien;
- Verdier, Marie‐Clémence
Publication type:
Article
Regulatory Pathways for Qualification and Acceptance of Digital Health Technology‐Derived Clinical Trial Endpoints: Considerations for Sponsors.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 56, doi. 10.1002/cpt.3398
By:
- Bakker, Jessie P.;
- Izmailova, Elena S.;
- Clement, Aude;
- Hoffmann, Steven;
- Leptak, Christopher;
- Menetski, Joseph P.;
- Wagner, John A.
Publication type:
Article
Issue Information.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 1, doi. 10.1002/cpt.3317
Publication type:
Article
Questioning Conclusions and Statements on the German HTA System: A Critical Perspective.
Published in:
Clinical Pharmacology & Therapeutics, 2025, v. 117, n. 1, p. 22, doi. 10.1002/cpt.3296
By:
- Tomeczkowski, Jörg;
- Heidbrede, Tanja;
- Leverkus, Friedhelm;
- Schmitter, Sarah;
- Dintsios, Charalabos‐Markos;
- Osowski, Ulrike;
- Herrmann, Kirsten H.;
- Bluhmki, Tobias;
- Marx, Almuth;
- Eichinger, Birte;
- Basic, Edin;
- Bussilliat, Paul;
- Dietrich, Eva Susanne
Publication type:
Article