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.

A cross-sectional study on the potential drug-drug interaction risk of COVID-19 patients in hospital
CONCLUSION: This study identified factors associated with potential DDIs, which can assist in changing medication strategies, preventing adverse drug reactions, and improving clinical efficacy.PMID:38660885 | DOI:10.5414/CP204435 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 25, 2024 Category: Drugs & Pharmacology Authors: Liu-Lyu Huang Bo Jiang Yong-Long Han Ying Liu Source Type: research

Pharmacokinetics of apixaban in patients undergoing pancreaticoduodenectomy (PAP-UP)
CONCLUSION: The pharmacokinetic characteristics of apixaban in subjects who had undergone pancreaticoduodenectomy are not significantly different from those of healthy controls. Though the sample size of this study is small, results suggest that no change to apixaban dose regimen is needed in patients who have had a pancreaticoduodenectomy.PMID:38660886 | DOI:10.5414/CP204502 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 25, 2024 Category: Drugs & Pharmacology Authors: Richard Zheng Edwin Lam Peter Altshuler Madison Crutcher Harish Lavu Charles J Yeo Douglas Stickle Benjamin Leiby Walter K Kraft Source Type: research

Hepatic Dysfunction Quantified by HepQuant DuO Outperforms Child-Pugh Classification in Predicting the Pharmacokinetics of Ampreloxetine
Clin Pharmacol Ther. 2024 Apr 23. doi: 10.1002/cpt.3265. Online ahead of print.ABSTRACTHepQuant tests quantify liver function from clearance of deuterium- and 13C-labeled cholates administered either intravenously and orally (SHUNT) or orally (DuO). Hepatic impairment studies have relied on clinical or laboratory criteria like Child-Pugh classification to categorize the degree of hepatic dysfunction. We compared HepQuant tests with Child-Pugh classification in predicting the pharmacokinetics of ampreloxetine. Twenty-one subjects with hepatic impairment (8 Child-Pugh A, 7 Child-Pugh B, and 6 Child-Pugh C), and 10 age- and s...
Source: Clinical Pharmacology and Therapeutics - April 24, 2024 Category: Drugs & Pharmacology Authors: Jitendra Kanodia Hugh Giovinazzo Wayne Yates David L Bourdet Michael P McRae Steve M Helmke Gregory T Everson Source Type: research

From the Randomized AMBORA Trial to Clinical Practice: Comparison of Medication Errors in Oral Antitumor Therapy
Clin Pharmacol Ther. 2024 Apr 24. doi: 10.1002/cpt.3266. Online ahead of print.ABSTRACTThe randomized AMBORA trial showed that medication errors are frequent in patients treated with oral antitumor therapeutics and that they can be substantially reduced by an intensified clinical pharmacological/pharmaceutical care program. While randomized controlled trials are essential to generate clinical evidence, their generalizability in real-world is not always given. The AMBORA care program was implemented in clinical routine within the AMBORA Competence and Consultation Center (AMBORA Center) at the Comprehensive Cancer Center Er...
Source: Clinical Pharmacology and Therapeutics - April 24, 2024 Category: Drugs & Pharmacology Authors: Lisa Cuba Pauline D ürr Frank D örje Martin F Fromm Katja Schlichtig Source Type: research

Leveraging QSP Models for MIPD: A Case Study for Warfarin/INR
Clin Pharmacol Ther. 2024 Apr 24. doi: 10.1002/cpt.3274. Online ahead of print.ABSTRACTWarfarin dosing remains challenging due to substantial inter-individual variability, which can lead to unsafe or ineffective therapy with standard dosing. Model-informed precision dosing (MIPD) can help individualize warfarin dosing, requiring the selection of a suitable model. For models developed from clinical data, the dependence on the study design and population raises questions about generalizability. Quantitative system pharmacology (QSP) models promise better extrapolation abilities; however, their complexity and lack of validati...
Source: Clinical Pharmacology and Therapeutics - April 24, 2024 Category: Drugs & Pharmacology Authors: Undine Falkenhagen Larisa H Cavallari Julio D Duarte Charlotte Kloft Stephan Schmidt Wilhelm Huisinga Source Type: research

Unlocking the Capabilities of Large Language Models for Accelerating Drug Development
Clin Pharmacol Ther. 2024 Apr 22. doi: 10.1002/cpt.3279. Online ahead of print.NO ABSTRACTPMID:38649744 | DOI:10.1002/cpt.3279 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 22, 2024 Category: Drugs & Pharmacology Authors: Wes Anderson Ian Braun Roopal Bhatnagar Klaus Romero Ramona Walls Marco Schito Jagdeep T Podichetty Source Type: research

Safety of Monoclonal Antibodies Inhibiting PCSK9 in Pregnancy: Disproportionality Analysis in VigiBase ®
In conclusion, this study showed that, currently, there are no signals of increased reporting of spontaneous abortion with alirocumab and evolocumab compared with the full database and statins in VigiBase®. Notwithstanding, lack of disproportionality is not synonymous with safety and, as disproportionality analyses depend on the number of safety reports that progressively accumulate in VigiBase®, they should be repeated at regular intervals to confirm the results of the present study.PMID:38637956 | DOI:10.1002/cpt.3269 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 19, 2024 Category: Drugs & Pharmacology Authors: Roberta Noseda Francesca Bedussi Alice Panchaud Alessandro Ceschi Source Type: research

Phenotype-Genotype Correlation Applying a Cocktail Approach and an Exome Chip Analysis Reveals Further Variants Contributing to Variation of Drug Metabolism
Clin Pharmacol Ther. 2024 Apr 18. doi: 10.1002/cpt.3270. Online ahead of print.ABSTRACTAlthough great progress has been made in the fine-tuning of diplotypes, there is still a need to further improve the predictability of individual phenotypes of pharmacogenetically relevant enzymes. The aim of this study was to analyze the additional contribution of sex and variants identified by exome chip analysis to the metabolic ratio of five probe drugs. A cocktail study applying dextromethorphan, losartan, omeprazole, midazolam, and caffeine was conducted on 200 healthy volunteers. CYP2D6, 2C9, 2C19, 3A4/5, and 1A2 genotypes were an...
Source: Clinical Pharmacology and Therapeutics - April 19, 2024 Category: Drugs & Pharmacology Authors: Ruwen B öhm Henrike Bruckmueller Stefan Oswald Matthias H übenthal Meike Kaehler Lena Ehmke Jan H öcker Werner Siegmund Andre Franke Ingolf Cascorbi Source Type: research

Model-Informed Assessment of Probability of Phase 3 Success for Ritlecitinib in Patients with Moderate-to-Severe Ulcerative Colitis
Clin Pharmacol Ther. 2024 Apr 16. doi: 10.1002/cpt.3251. Online ahead of print.ABSTRACTRitlecitinib, an oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family inhibitor, was evaluated in patients with ulcerative colitis (UC) in a phase 2b trial. Model-informed drug development strategies were applied to bridge observations from phase 2b to predictions for a proposed phase 3 study design to assess the probability of achieving the target efficacy outcome. A longitudinal exposure-response model of the time course of the 4 Mayo subscores (rectal bleeding, stool frequency, physician's global assessment...
Source: Clinical Pharmacology and Therapeutics - April 17, 2024 Category: Drugs & Pharmacology Authors: Jessica Wojciechowski Arnab Mukherjee Christopher Banfield Timothy Nicholas Source Type: research

Best Practices for Pharmacokinetic Studies of New Chemical Entities
Clin Pharmacol Ther. 2024 May;115(5):917-919. doi: 10.1002/cpt.3231.NO ABSTRACTPMID:38629332 | DOI:10.1002/cpt.3231 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 17, 2024 Category: Drugs & Pharmacology Authors: Ya-Feng Wen Piet H van der Graaf Source Type: research

Patient-Centric Clinical Pharmacology: A Journey from Discovery to Recovery
Clin Pharmacol Ther. 2024 May;115(5):928-930. doi: 10.1002/cpt.3243.NO ABSTRACTPMID:38629339 | DOI:10.1002/cpt.3243 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 17, 2024 Category: Drugs & Pharmacology Authors: Mohamed H Shahin Matthew L Rizk Source Type: research

Comparative Safety of Long-Acting vs. Short-Acting Erythropoiesis-Stimulating Agents Among Patients Undergoing Hemodialysis
Clin Pharmacol Ther. 2024 Apr 17. doi: 10.1002/cpt.3271. Online ahead of print.ABSTRACTBoth short-acting (epoetin alfa or beta) and long-acting (darbepoetin alfa or PEG-epoetin) erythropoiesis-stimulating agents (ESAs) are commonly prescribed for patients with kidney failure undergoing maintenance hemodialysis. We compared the risks of major adverse cardiovascular events (MACE) and of all-cause mortality associated with receipt of short- vs. long-acting ESAs. This retrospective cohort analysis included Medicare hemodialysis beneficiaries aged ≥ 18 years in the United States Renal Data System from January 2015 to December...
Source: Clinical Pharmacology and Therapeutics - April 17, 2024 Category: Drugs & Pharmacology Authors: Raj Desai Ikenna Unigwe Munaza Riaz Steven M Smith Ashutosh M Shukla Rajesh Mohandas Nakyung Jeon Haesuk Park Source Type: research