Clinical Pharmacology and Therapeutics This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Identifying Drug-Drug Interactions in Spontaneous Reports Utilizing Signal Detection and Biological Plausibility Aspects
Clin Pharmacol Ther. 2024 Apr 8. doi: 10.1002/cpt.3258. Online ahead of print.ABSTRACTTranslational approaches can benefit post-marketing drug safety surveillance through the growing availability of systems pharmacology data. Here, we propose a novel Bayesian framework for identifying drug-drug interaction (DDI) signals and differentiating between individual drug and drug combination signals. This framework is coupled with a systems pharmacology approach for automated biological plausibility assessment. Integrating statistical and biological evidence, our method achieves a 16.5% improvement (AUC: from 0.620 to 0.722) with ...
Source: Clinical Pharmacology and Therapeutics - April 9, 2024 Category: Drugs & Pharmacology Authors: Elpida Kontsioti Simon Maskell Isobel Anderson Munir Pirmohamed Source Type: research

A crossover study to evaluate the pharmacokinetics and bioequivalence of hydroxychloroquine tablets in healthy Chinese subjects
CONCLUSION: The investigation demonstrated that the test and reference preparations are bioequivalent and well tolerated under both fasting and fed conditions in healthy Chinese subjects.PMID:38577751 | DOI:10.5414/CP204406 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 5, 2024 Category: Drugs & Pharmacology Authors: Jie Feng Shuang-Yu Kuang Jun-Han Wan Rong Li Yi-Jie Zhu Bei-Lei Cai Lei Guan Zheng Zhang Source Type: research

Association between serum IgG concentrations and the incidence of infections in patients with chronic lymphocytic leukemia and secondary immunodeficiency under treatment with Privigen
CONCLUSION: This analysis confirms the association of serum IgG trough levels with the incidence of infections and highlights the importance of careful monitoring of IgG levels during treatment of secondary immunodeficiencies in CLL patients.PMID:38577752 | DOI:10.5414/CP204473 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 5, 2024 Category: Drugs & Pharmacology Authors: Burkhard Otremba Ferdinand Haslbauer Marcel Reiser Rudolf Weide Michael Obermeier Dietmar Pfr ünder Source Type: research

Effectiveness of atropine in managing sialorrhea: A systematic review and meta-analysis
CONCLUSION: Atropine is efficacious in managing sialorrhea in most disease states. Sublingual administration of atropine is superior to other routes of administration in reducing salivary flow in patients with sialorrhea.PMID:38577753 | DOI:10.5414/CP204538 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 5, 2024 Category: Drugs & Pharmacology Authors: Venkata K Yellepeddi Jonathan A Race Mary M McFarland Jonathan E Constance Elika Fanaeian Nancy A Murphy Source Type: research

The Use of Real-World Evidence for Regulatory Decisions in China
This study aims to review the use of RWE in Chinese regulatory decisions and to summarize relevant regulatory and methodological considerations to inform the future use of RWE in China. We identified policy documents, technical guidance documents, and cases on official Chinese government websites and extracted their contents separately. We consulted experts from the National Medical Products Administration (NMPA) and academic institutes and searched case-related articles for enrichment. We also searched and included articles related to the use of RWE/Real-world data in Chinese regulatory decisions. Six trial versions of te...
Source: Clinical Pharmacology and Therapeutics - April 3, 2024 Category: Drugs & Pharmacology Authors: Jiayue Xu Wenkai Wu Xia Zhang Yan Ren Minghong Yao Mei Liu Kang Zou Wen Wang Xin Sun Source Type: research