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.

Regulatory Issues of Platform Trials: Learnings from EU-PEARL
Clin Pharmacol Ther. 2024 Mar 26. doi: 10.1002/cpt.3244. Online ahead of print.ABSTRACTAlthough platform trials have many benefits, the complexity of these designs may result not only in increased methodological but also regulatory and ethical challenges. These aspects were addressed as part of the IMI project EU Patient-Centric Clinical Trial Platforms (EU-PEARL). We reviewed the available guidelines on platform trials in the European Union and the United States. This is supported and complemented by feedback received from regulatory interactions with the European Medicines Agency and the US Food and Drug Administration. ...
Source: Clinical Pharmacology and Therapeutics - March 26, 2024 Category: Drugs & Pharmacology Authors: Quynh Lan Nguyen Katharina Hees Sabina Hernandez Penna Franz K önig Martin Posch Marta Bofill Roig Elias Laurin Meyer Michaela Maria Freitag Tom Parke Maximilian Otte Hans-Peter Dauben Tobias Mielke Cecile Spiertz Peter Mesenbrink Madhavi Gidh-Jain Suzan Source Type: research

Transdermal Nicotine Patch Increases the Number and Function of Endothelial Progenitor Cells in Young Healthy Nonsmokers without Adverse Hemodynamic Effects
In conclusion, 7-day TNP treatments could be a practical strategy to enhance angiogenesis of circulating EPCs to alleviate tissue ischemia without any hemodynamic concern.PMID:38529793 | DOI:10.1002/cpt.3249 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 26, 2024 Category: Drugs & Pharmacology Authors: Yen-Yu Liu Ting-Yi Tien Chung-Lieh Hung Yih-Jer Wu Cheng-Huang Su Hung-I Yeh Source Type: research

Primary and secondary prevention of stroke and cardiovascular events using evolocumab and alirocumab: Meta-analysis of randomized controlled trials
CONCLUSION: Our findings indicate that evolocumab and alirocumab are significantly effective without increasing the risk of hemorrhagic stroke. Based on this, the PCSK9 inhibitors can be highly recommended for cholesterol management.PMID:38529927 | DOI:10.5414/CP204506 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 26, 2024 Category: Drugs & Pharmacology Authors: Kwang-Hee Shin Hye Duck Choi Source Type: research

Therapeutic drug monitoring of vancomycin in surgical patients through a validated HPLC method
CONCLUSION: The developed method is sensitive and cost effective for quantification of vancomycin in human plasma. The results of sample analysis shows that the developed method can be used reliably for TDM of vancomycin.PMID:38529928 | DOI:10.5414/CP204534 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 26, 2024 Category: Drugs & Pharmacology Authors: Muhammad Noman Akram Muhammad Imran Khokhar Mateen Abbas Muhammad Khurram Waqas Mian Waqar Mustafa Abdulhakeem S Alamri Majid Alhomrani Walaa F Alsanie Muhammad Usman Source Type: research

Population Pharmacokinetics of Cabotegravir Following Oral Administration and Long-Acting Intramuscular Injection in Real-World People with HIV
Clin Pharmacol Ther. 2024 Mar 22. doi: 10.1002/cpt.3240. Online ahead of print.ABSTRACTLong-acting cabotegravir has been studied mainly in the stringent framework of clinical trials, which does not necessarily reflect the situation of people with HIV (PWH) in routine clinical settings. The present population pharmacokinetic analysis aims to build real-world reference percentile curves of cabotegravir concentrations, accounting for patient-related factors that may affect cabotegravir exposure. The second objective is to simulate whether dosing interval adjustments of cabotegravir could be considered in specific subpopulatio...
Source: Clinical Pharmacology and Therapeutics - March 23, 2024 Category: Drugs & Pharmacology Authors: Paul Thoueille Susana Alves Saldanha Fabian Schaller Eva Choong Fran çois Veuve Aline Munting Matthias Cavassini Dominique Braun Huldrych F G ünthard Jessy J Duran Ramirez Bernard Surial Hansjakob Furrer Andri Rauch Pilar Ustero Alexandra Calmy Marcel S Source Type: research

Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting Program
In this report, we describe the collective experiences of industry participants in the MIDD Program to date, including all aspects of the process from meeting request submission to follow-up actions. The purpose is to provide future participants with information to optimize the value of the MIDD Program.PMID:38519861 | DOI:10.1002/cpt.3245 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 23, 2024 Category: Drugs & Pharmacology Authors: Gerald R Galluppi Malidi Ahamadi Souvik Bhattacharya Nageshwar Budha Ferdous Gheyas Chi-Chung Li Yuan Chen Anne-Ga ëlle Dosne Niels Rode Kristensen Mindy Magee Mahesh N Samtani Vikram Sinha Kunal Taskar Vijay V Upreti Jianning Yang Jack Cook Source Type: research

Agreement about Availability of Alternative Treatments for Innovative Drugs Assessed by the EMA and HTA Organizations
In conclusion, although there was high overall agreement between the EMA and HTA organizations about whether alternative treatments exist, there were differences in the types of treatment considered. Parallel joint scientific consultations could inform drug developers about relevant alternative treatments to facilitate patient access to innovative drugs.PMID:38505926 | DOI:10.1002/cpt.3252 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 20, 2024 Category: Drugs & Pharmacology Authors: Jorge Madrid Paredes Jan-Willem Versteeg Rick A Vreman Lourens T Bloem Source Type: research

Artificial Intelligence/Machine Learning: The New Frontier of Clinical Pharmacology and Precision Medicine
Clin Pharmacol Ther. 2024 Apr;115(4):637-642. doi: 10.1002/cpt.3198.NO ABSTRACTPMID:38505955 | DOI:10.1002/cpt.3198 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - March 20, 2024 Category: Drugs & Pharmacology Authors: Qi Liu Amita Joshi Joseph F Standing Piet H van der Graaf Source Type: research

A Benefit-Risk Conceptual Framework for Biologic Use During Pregnancy: A Mini-Review
Clin Pharmacol Ther. 2024 Mar 20. doi: 10.1002/cpt.3239. Online ahead of print.ABSTRACTRecent reports related to in utero exposure of marketed immunosuppressive biologics led to clinical recommendations to delay live vaccinations for infants due to the concern of reduced vaccine effectiveness and/or increased risk of vaccine-related disease. These delays can increase the risk of children contracting vaccine preventable diseases, yet the alternative cessation of biologics during pregnancy may result in increased autoimmune disease activity for the pregnant person, raising complex benefit-risk (B-R) considerations and trade-...
Source: Clinical Pharmacology and Therapeutics - March 20, 2024 Category: Drugs & Pharmacology Authors: Laura M Bozzi Melanie H Jacobson Emily Yost Anna Sheahan Joseph Cafone Yosuke Komatsu Lisa Schwartz Bennett Levitan Robert M Nelson Source Type: research