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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

Optimizing Dosage in Pharmacotherapy-Missing the Forest for the Trees
Clin Pharmacol Ther. 2024 Apr 15. doi: 10.1002/cpt.3268. Online ahead of print.NO ABSTRACTPMID:38618676 | DOI:10.1002/cpt.3268 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 15, 2024 Category: Drugs & Pharmacology Authors: Susan M Abdel-Rahman Andrew J Farrell N Seth Berry Gilbert J Burckart Source Type: research

Therapeutic Drug Monitoring of Oral Oncology Drugs: Another Example of Maslow's Hammer
Clin Pharmacol Ther. 2024 Apr 11. doi: 10.1002/cpt.3264. Online ahead of print.NO ABSTRACTPMID:38605551 | DOI:10.1002/cpt.3264 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 12, 2024 Category: Drugs & Pharmacology Authors: Mark J Ratain Source Type: research

Calcineurin inhibitors experience in unplanned pregnancies with active lupus disease: A retrospective observational study
CONCLUSION: This study reveals that tacrolimus can be effectively used in unplanned pregnancies with active lupus disease, providing favorable maternal and fetal outcomes. The findings emphasize the importance of considering CNIs, particularly tacrolimus, in the management of SLE pregnancies, even in cases of unplanned pregnancies with a history of lupus nephritis.PMID:38606855 | DOI:10.5414/CP204528 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 12, 2024 Category: Drugs & Pharmacology Authors: İbrahim Vasi Derya Y ıldırım R ıza Can Kardaş Burcug ül Kaya Rahime Duran Gizem Tu ğçe Alp Hazan Karadeniz Asl ıhan Avanoğlu Güler Hamit K üçük Berna G öker Abdurrahman Tufan Mehmet Akif Öztürk Abdulsamet Erden Source Type: research

Acute liver failure caused by high-dose tigecycline: A case report
We report the case of a 76-year-old female patient with cerebral hemorrhage who received high-dose tigecycline (100 mg q12h) with other drugs for ventilator-associated pneumonia. 25 days after admission, she developed acute liver failure, mainly manifested by abnormally high bilirubin, coagulation dysfunction, and gastrointestinal hemorrhage with hemorrhagic shock. According to the updated Roussel Uclaf causality assessment method, the patient's acute liver injury was most likely caused by tigecycline.PMID:38606856 | DOI:10.5414/CP204549 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 12, 2024 Category: Drugs & Pharmacology Authors: Yingpei Zhang Jiajun Wang Yibin Tan Jianhua Wu Source Type: research