Results 51 to 60 of about 6,306 (210)

Population pharmacokinetics and standard uptake value ratio of aducanumab, an amyloid plaque–removing agent, in patients with Alzheimer’s disease

CPT: Pharmacometrics & Systems Pharmacology, 2022
Aducanumab is a human immunoglobulin G1 anti‐amyloid beta (Aβ) antibody currently being evaluated for potential treatment of patients with early Alzheimer’s disease.
Kumar Kandadi Muralidharan, Xiao Tong, Kenneth G. Kowalski, Raj Rajagovindan, Lin Lin, Samantha Budd Haberlain, Ivan Nestorov   +6 more
doaj   +1 more source

Capacity building in medicines development and regulation in Africa—Overview on recent progress

British Journal of Clinical Pharmacology, EarlyView.
Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke, Emile Malan, Michael Reid, Patrick Bouic, Haylene Nell, Goonaseelan Pillai, Catriona Waitt, Bernd Rosenkranz   +7 more
wiley   +1 more source

Clinical Model‐Informed Precision Dosing Consult Service for Accelerating Personalized Medication in Pediatric Patients

Clinical Pharmacology &Therapeutics, EarlyView.
Traditional dosing strategies often rely on a “one‐size‐fits‐all” paradigm, assuming an “average” patient with typical demographic and pharmacological characteristics. In reality, this often overlooks existing between‐patient variability and can lead to suboptimal drug exposure or toxicity. This issue is especially pronounced in pediatric patients, who
Zachary L. Taylor, Takanobu Nadai, Kei Irie, Wen Rui Tan, Sanjana Parikh, Anhar Hosawi, Matthijs W. van Hoogdalem, Ronaldo Morales Junior, Sonya Tang Girdwood, Abbie D. Leino, Kana Mizuno, Alexander A. Vinks, Tomoyuki Mizuno   +12 more
wiley   +1 more source

Tutorial on Causal Mediation Analysis for Pharmacometricians

CPT: Pharmacometrics & Systems Pharmacology
Mediation analyses can support biomarker development by quantifying the part of the total treatment effect on clinical outcome that is mediated by the biomarker.
Sebastiaan Camiel Goulooze, Eleonora Marostica, Nelleke Snelder   +2 more
doaj   +1 more source

Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women With Endometriosis‐Associated Pain: An Application of Markov Model

CPT: Pharmacometrics & Systems Pharmacology, 2020
Elagolix is an oral gonadotropin‐releasing hormone antagonist approved by the US Food and Drug Administration (FDA) for the management of moderate‐to‐severe pain associated with endometriosis and in combination with estradiol/norethindrone acetate ...
Insa Winzenborg, Akshanth R. Polepally, Ahmed Nader, Nael M. Mostafa, Peter Noertersheuser, Juki Ng   +5 more
doaj   +1 more source

AI‐Enabled Precision Dosing in Pediatrics: Enhancing Model‐Informed Decision Making

Clinical Pharmacology &Therapeutics, EarlyView.
Ensuring safe and effective pharmacotherapy for children remains a central challenge in clinical pharmacology, yet rapid advances in AI have not translated into clinical practice. This Perspective highlights how AI‐enabled approaches can enhance model‐informed decision making for precision dosing.
Kei Irie, Tomoyuki Mizuno
wiley   +1 more source

Evaluation of machine learning methods for covariate data imputation in pharmacometrics

CPT: Pharmacometrics & Systems Pharmacology, 2022
Missing data create challenges in clinical research because they lead to loss of statistical power and potentially to biased results. Missing covariate data must be handled with suitable approaches to prepare datasets for pharmacometric analyses, such as
Dominic Stefan Bräm, Uri Nahum, Andrew Atkinson, Gilbert Koch, Marc Pfister   +4 more
doaj   +1 more source

Digital Transformation of Medicines Regulation in Africa—Perspectives from a Stakeholder Convening

Clinical Pharmacology &Therapeutics, EarlyView.
Regulatory authorities worldwide are developing strategies to integrate artificial intelligence (AI) into the lifecycle of health products, technologies, and medicines. While regulators share goals of improving efficiency, strengthening decision‐making, and protecting public health, their approaches differ according to institutional structures ...
Christelna Reyneke, Boitumelo Semete‐Makokotlela, Varnika Singh, Khanyisile Nkuku, Madelein Terblanche, Ezekiel T Mukanga, Nancy Ngum, Kudakwashe Dandajena, McNeil Chimus Mhango, Paulyne Wairimu, John Mwangi, Dominique Lagrave, Goonaseelan (Colin) Pillai   +12 more
wiley   +1 more source

Time‐Dependent Bias and Prognostic Confounding in Exposure–Response Analysis of Targeted Therapies: Lessons from Sunitinib in Metastatic Renal Cancer

Clinical Pharmacology &Therapeutics, EarlyView.
Exposure–response (E–R) analyses of sunitinib in metastatic renal cell carcinoma (mRCC) have supported concentration‐guided dose escalation. However, such analyses may be biased when exposure metrics incorporate post‐baseline dose modifications, time‐varying apparent clearance, or baseline factors that influence both pharmacokinetics and clinical ...
Han Liu, Lena E. Friberg
wiley   +1 more source

Intranasal diamorphine population pharmacokinetics modeling and simulation in pediatric breakthrough pain

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 435-447, March 2025.
Abstract Intranasal diamorphine (IND), approved for managing breakthrough pain in the UK, has been identified as an acceptable alternative offering effective, expedient, and less traumatic analgesia for children. However, the current dose regimen in pediatric populations relies on clinical expertise while the pharmacokinetics properties are poorly ...
Lianjin Cai, Jingchen Zhai, Beihong Ji, Fengyang Han, Taoyu Niu, Luxuan Wang, Junmei Wang   +6 more
wiley   +1 more source