Results 251 to 260 of about 156,017 (326)

Model‐Informed Drug Development for Daprodustat Supports the Design of Individualized Dosing Regimens in Chronic Kidney Disease Patients With Anemia

Clinical Pharmacology &Therapeutics, EarlyView.
Model‐informed drug development (MIDD) played a crucial role in the successful development and regulatory approval of daprodustat, a novel oral hypoxia‐inducible factor prolyl hydroxylase (HIF‐PHI) inhibitor aimed at treating anemia in chronic kidney disease patients.
Kelly M. Mahar, Shuying Yang, Brendan Johnson, Sandra A.G. Visser, Paul van den Berg, Martijn van Noort, Teun M. Post   +6 more
wiley   +1 more source

The Possibility of Open-Label Use of Placebo in Healthcare Practice: A Systematic Review of Recent Clinical Trials. [PDF]

Cureus
Tao FCW, Ghafoor F, Yang N.
europepmc   +1 more source

Large Language Models for Clinical Trial Protocol Assessments

Clinical Pharmacology &Therapeutics, EarlyView.
The purpose was to evaluate the utility of large language models (LLMs) for reviewing the statistical analysis plan (SAP) and pharmacokinetics–pharmacodynamics (PK–PD) components of clinical trial protocols. Clinical trial protocols and SAPs were obtained from clinicaltrials.gov for a testbed of 15 small‐molecule drugs, biologics, and global antibiotic
Euibeom Shin, Amruta Gajanan Bhat, Murali Ramanathan   +2 more
wiley   +1 more source

Real‐World Edoxaban Concentrations in Older Patients Receiving Reduced‐Dose Regimens

Clinical Pharmacology &Therapeutics, EarlyView.
Real‐world edoxaban concentrations in older patients receiving reduced‐dose regimens. Low trough concentrations (< 12 ng/mL) were associated with an increased risk of thromboembolism. Among patients meeting the ELDERCARE‐AF criteria, low drug levels were more frequent with the 15 mg regimen than with the 30 mg regimen.
Sung‐Chun Tang, Shin‐Yi Lin, Chih‐Hao Chen, Yen‐Bin Liu, Li‐Ting Ho, Ching‐Hua Kuo, Yu‐Fong Peng, Chih‐Fen Huang, Jiann‐Shing Jeng   +8 more
wiley   +1 more source

Efficacy and Safety of 5-Aminolevulinic Acid Hydrochloride Combined with Sodium Ferrous Citrate in Pediatric Patients with Leigh Syndrome and Central Nervous System Disorders: An Initial Exploratory Trial with a Double-Blind Placebo-Controlled Period, Followed by an Open-Label Period and a Subsequent Long-Term Administration Study [PDF]

Yuichi Abe, Toshimitsu Hamasaki, Jun Natsume, Yukiko Mogami, Kei Murayama, Hideaki Shiraishi, Yuki Abe, Satoko Kumada, Ryuta Tanaka, Kenji Ihara, Takafumi Sakakibara, Yasushi Okazaki, Hitoshi Nakagawa, Kiwamu Takahashi, Mitsugu Yamauchi, Motowo Nakajima, Akira Ohtake   +16 more
openalex   +1 more source

Hydroxychloroquine in the treatment of anti-histamine refractory chronic spontaneous urticaria, randomized single-blinded placebo-controlled trial and an open label comparison study.

European Annals of Allergy and Clinical Immunology, 2017
T. Boonpiyathad, A. Sangasapaviliya
semanticscholar   +1 more source

Biomarkers of Drug‐Induced Kidney Injury: Use in Clinical Trials and Recent Examples of Impact on Drug Development

Clinical Pharmacology &Therapeutics, EarlyView.
This manuscript describes the scope of implementation and impact of a regulatory agency‐qualified panel of six urine biomarkers on drug development, the process for which was conducted and funded by the Critical Path Institute, the Foundation for the National Institutes of Health, and the United States Food and Drug Administration.
Tanja S. Zabka, Michael Lawton, Tom Chu, Gary S. Friedman, Katrina Peron, Stefan R. Sultana, Warren E. Glaab, Nicholas M. P. King   +7 more
wiley   +1 more source

The Placebo Effect in Medicine and Clinical Practice: A Narrative Review. [PDF]

Cureus
Tzigkounakis G, Simati K, Georgiadis K.
europepmc   +1 more source

Verekitug, a Novel Antibody Antagonist to the TSLP Receptor in Adults with Asthma: A 32‐Week Randomized Phase 1b Multiple Ascending‐Dose Trial

Clinical Pharmacology &Therapeutics, EarlyView.
Verekitug, a novel, high‐affinity, fully human monoclonal antibody targeting thymic stromal lymphopoietin receptor (TSLPR), is in development as a potential treatment for severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and chronic obstructive pulmonary disease (COPD).
Dave Singh, Chaim M. Brickman, Peter Lloyd, Ashish Kalra, Subhabrata Biswas, Arkadeep Sinha, Alex Mulvanny, Sumathi Sivapalasingam, Oren M. Becker, Aaron Deykin   +9 more
wiley   +1 more source

Mo1007 Curcumin, Anti-Oxidant, and Pioglitazone Therapy With Inclusion of Vitamin E in Non Alcoholic Fatty Liver Disease-a Randomized Open Label Placebo Controlled Clinical Prospective Trial (CAPTIVE)

, 2013
Patrick Basu, Niraj James Shah, Ravi Siriki, Kavya Mittimani, Srilakshmi Atluri, Khandoker Asiqur Rahaman, Sakina Farhat, Robert S. Brown   +7 more
openalex   +1 more source