Factors Influencing Change in Serum Uric Acid after Administration of the Sodium-Glucose Cotransporter 2 Inhibitor Luseogliflozin in Patients With Type 2 Diabetes Mellitus
This article is protected by copyright. All rights reserved.PMID:34545949 | DOI:10.1002/jcph.1970 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - September 21, 2021 Category: Drugs & Pharmacology Authors: Yukihiro Chino Masanari Kuwabara Ichiro Hisatome Source Type: research

A Model-Based Framework to Inform the Dose Selection and Study Design of Emicizumab for Pediatric Patients with Hemophilia A
This article is protected by copyright. All rights reserved.PMID:34545950 | DOI:10.1002/jcph.1968 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - September 21, 2021 Category: Drugs & Pharmacology Authors: Koichiro Yoneyama Christophe Schmitt Tiffany Chang Christophe Dhalluin Sayaka Nagami Claire Petry Gallia G Levy Source Type: research

Evaluation Of Individualized Cefepime Dosing Strategy Using Population Pharmacokinetics
This article is protected by copyright. All rights reserved.PMID:34542174 | DOI:10.1002/jcph.1967 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - September 20, 2021 Category: Drugs & Pharmacology Authors: Yoonsun Mo Natalia Shcherbakova Kelsey L Inman Wai Kin Li Kateryna Kovalenko Joshua Rosenberg Jose Orsini Source Type: research

Whether immunostimulants are effective in susceptible children suffering from recurrent respiratory tract infections: a modeling analysis based on literature aggregate data
This study provides quantitative support for the application of immunostimulants for the prevention of recurrent respiratory tract infections in children. This article is protected by copyright. All rights reserved.PMID:34535904 | DOI:10.1002/jcph.1969 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - September 18, 2021 Category: Drugs & Pharmacology Authors: Weilong Zhang Jihan Huang Hongxia Liu Xin Wen Qingshan Zheng Lujin Li Source Type: research

Dosing Regimen Prediction and Confirmation with Rivaroxaban for Thromboprophylaxis in Children after the Fontan Procedure: Insights from the Phase III UNIVERSE Study
This article is protected by copyright. All rights reserved.PMID:34524700 | DOI:10.1002/jcph.1966 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - September 15, 2021 Category: Drugs & Pharmacology Authors: Peijuan Zhu Stefan Willmann Wangda Zhou Haitao Yang Alan D Michelson Brian W McCrindle Jennifer S Li Kevin C Harris Liza Miriam Pina Traci Weber Kimberly Nessel Lawrence J Lesko Dagmar Kubitza Peter Zannikos Source Type: research

Dosing Regimen Prediction and Confirmation with Rivaroxaban for Thromboprophylaxis in Children after the Fontan Procedure: Insights from the Phase III UNIVERSE Study
This article is protected by copyright. All rights reserved.PMID:34524700 | DOI:10.1002/jcph.1966 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - September 15, 2021 Category: Drugs & Pharmacology Authors: Peijuan Zhu Stefan Willmann Wangda Zhou Haitao Yang Alan D Michelson Brian W McCrindle Jennifer S Li Kevin C Harris Liza Miriam Pina Traci Weber Kimberly Nessel Lawrence J Lesko Dagmar Kubitza Peter Zannikos Source Type: research

Dosing Regimen Prediction and Confirmation with Rivaroxaban for Thromboprophylaxis in Children after the Fontan Procedure: Insights from the Phase III UNIVERSE Study
This article is protected by copyright. All rights reserved.PMID:34524700 | DOI:10.1002/jcph.1966 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - September 15, 2021 Category: Drugs & Pharmacology Authors: Peijuan Zhu Stefan Willmann Wangda Zhou Haitao Yang Alan D Michelson Brian W McCrindle Jennifer S Li Kevin C Harris Liza Miriam Pina Traci Weber Kimberly Nessel Lawrence J Lesko Dagmar Kubitza Peter Zannikos Source Type: research

Dosing Regimen Prediction and Confirmation with Rivaroxaban for Thromboprophylaxis in Children after the Fontan Procedure: Insights from the Phase III UNIVERSE Study
This article is protected by copyright. All rights reserved.PMID:34524700 | DOI:10.1002/jcph.1966 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - September 15, 2021 Category: Drugs & Pharmacology Authors: Peijuan Zhu Stefan Willmann Wangda Zhou Haitao Yang Alan D Michelson Brian W McCrindle Jennifer S Li Kevin C Harris Liza Miriam Pina Traci Weber Kimberly Nessel Lawrence J Lesko Dagmar Kubitza Peter Zannikos Source Type: research

Dosing Regimen Prediction and Confirmation with Rivaroxaban for Thromboprophylaxis in Children after the Fontan Procedure: Insights from the Phase III UNIVERSE Study
This article is protected by copyright. All rights reserved.PMID:34524700 | DOI:10.1002/jcph.1966 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - September 15, 2021 Category: Drugs & Pharmacology Authors: Peijuan Zhu Stefan Willmann Wangda Zhou Haitao Yang Alan D Michelson Brian W McCrindle Jennifer S Li Kevin C Harris Liza Miriam Pina Traci Weber Kimberly Nessel Lawrence J Lesko Dagmar Kubitza Peter Zannikos Source Type: research

Metformin and the risk of anemia of advanced chronic kidney disease in patients with Type 2 Diabetes mellitus
This article is protected by copyright. All rights reserved.PMID:34510471 | DOI:10.1002/jcph.1965 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - September 12, 2021 Category: Drugs & Pharmacology Authors: Chien-Tung Wu Yueh-Ting Tsai Hsuan-Kuang Jung Shu-Ling Fu Chao A Hsiung Hsiao-Yu Liu Jung-Nien Lai Source Type: research

Metformin and the risk of anemia of advanced chronic kidney disease in patients with Type 2 Diabetes mellitus
This article is protected by copyright. All rights reserved.PMID:34510471 | DOI:10.1002/jcph.1965 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - September 12, 2021 Category: Drugs & Pharmacology Authors: Chien-Tung Wu Yueh-Ting Tsai Hsuan-Kuang Jung Shu-Ling Fu Chao A Hsiung Hsiao-Yu Liu Jung-Nien Lai Source Type: research

Metformin and the risk of anemia of advanced chronic kidney disease in patients with Type 2 Diabetes mellitus
This article is protected by copyright. All rights reserved.PMID:34510471 | DOI:10.1002/jcph.1965 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - September 12, 2021 Category: Drugs & Pharmacology Authors: Chien-Tung Wu Yueh-Ting Tsai Hsuan-Kuang Jung Shu-Ling Fu Chao A Hsiung Hsiao-Yu Liu Jung-Nien Lai Source Type: research

Antibody-Mediated Rejection in Adult Liver Transplant Recipients: A Case Series and Literature Review
This study describes eight adult liver transplantation recipients who developed antibody-mediated rejection between 2002 and 2021 in our center, as well as a review of the literature on the reported cases of antibody-mediated rejection in liver transplantation recipients. Our center's medical records were reviewed retrospectively to extract the necessary data on patients' characteristics, management, and outcomes. Then, a comprehensive search using Embase, PubMed, Web of Science, Cochrane library, and Google Scholar databases was conducted without time limitation until June, 2021. Finally, a stepwise protocol was developed...
Source: The Journal of Clinical Pharmacology - September 4, 2021 Category: Drugs & Pharmacology Authors: Hananeh Baradaran Simin Dashti-Khavidaki Mohammad Taher Monavar Talebian Mohsen Nasiri-Toosi Ali Jafarian Source Type: research

Association between steroid use and nephropathy in patients who were administered a proton pump inhibitor: Analysis of the Japanese Adverse Event Report database
This study used the Japanese Adverse Drug Event Report database to investigate whether steroid use decreases the risk of nephropathy in patients who were administered a proton pump inhibitor (PPI). Disproportionality of kidney injury was observed between patients who did and those who did not use steroids while taking lansoprazole (reporting odds ratio [ROR]: 0.78, 95% confidence interval [CI]: 0.65-0.93; P = 0.002) or rabeprazole (ROR: 0.69, 95% CI: 0.53-0.89; P = 0.005). Multiple logistic regression analysis revealed a significantly negative association of kidney injury with steroid use (odds ratio [OR] 0.85, 95% CI 0.75...
Source: The Journal of Clinical Pharmacology - September 4, 2021 Category: Drugs & Pharmacology Authors: Satoru Mitsuboshi Ryohei Kaseda Ichiei Narita Source Type: research

Antibody-Mediated Rejection in Adult Liver Transplant Recipients: A Case Series and Literature Review
This study describes eight adult liver transplantation recipients who developed antibody-mediated rejection between 2002 and 2021 in our center, as well as a review of the literature on the reported cases of antibody-mediated rejection in liver transplantation recipients. Our center's medical records were reviewed retrospectively to extract the necessary data on patients' characteristics, management, and outcomes. Then, a comprehensive search using Embase, PubMed, Web of Science, Cochrane library, and Google Scholar databases was conducted without time limitation until June, 2021. Finally, a stepwise protocol was developed...
Source: The Journal of Clinical Pharmacology - September 4, 2021 Category: Drugs & Pharmacology Authors: Hananeh Baradaran Simin Dashti-Khavidaki Mohammad Taher Monavar Talebian Mohsen Nasiri-Toosi Ali Jafarian Source Type: research

Association between steroid use and nephropathy in patients who were administered a proton pump inhibitor: Analysis of the Japanese Adverse Event Report database
This study used the Japanese Adverse Drug Event Report database to investigate whether steroid use decreases the risk of nephropathy in patients who were administered a proton pump inhibitor (PPI). Disproportionality of kidney injury was observed between patients who did and those who did not use steroids while taking lansoprazole (reporting odds ratio [ROR]: 0.78, 95% confidence interval [CI]: 0.65-0.93; P = 0.002) or rabeprazole (ROR: 0.69, 95% CI: 0.53-0.89; P = 0.005). Multiple logistic regression analysis revealed a significantly negative association of kidney injury with steroid use (odds ratio [OR] 0.85, 95% CI 0.75...
Source: The Journal of Clinical Pharmacology - September 4, 2021 Category: Drugs & Pharmacology Authors: Satoru Mitsuboshi Ryohei Kaseda Ichiei Narita Source Type: research

Antibody-Mediated Rejection in Adult Liver Transplant Recipients: A Case Series and Literature Review
This study describes eight adult liver transplantation recipients who developed antibody-mediated rejection between 2002 and 2021 in our center, as well as a review of the literature on the reported cases of antibody-mediated rejection in liver transplantation recipients. Our center's medical records were reviewed retrospectively to extract the necessary data on patients' characteristics, management, and outcomes. Then, a comprehensive search using Embase, PubMed, Web of Science, Cochrane library, and Google Scholar databases was conducted without time limitation until June, 2021. Finally, a stepwise protocol was developed...
Source: The Journal of Clinical Pharmacology - September 4, 2021 Category: Drugs & Pharmacology Authors: Hananeh Baradaran Simin Dashti-Khavidaki Mohammad Taher Monavar Talebian Mohsen Nasiri-Toosi Ali Jafarian Source Type: research

Association between steroid use and nephropathy in patients who were administered a proton pump inhibitor: Analysis of the Japanese Adverse Event Report database
This study used the Japanese Adverse Drug Event Report database to investigate whether steroid use decreases the risk of nephropathy in patients who were administered a proton pump inhibitor (PPI). Disproportionality of kidney injury was observed between patients who did and those who did not use steroids while taking lansoprazole (reporting odds ratio [ROR]: 0.78, 95% confidence interval [CI]: 0.65-0.93; P = 0.002) or rabeprazole (ROR: 0.69, 95% CI: 0.53-0.89; P = 0.005). Multiple logistic regression analysis revealed a significantly negative association of kidney injury with steroid use (odds ratio [OR] 0.85, 95% CI 0.75...
Source: The Journal of Clinical Pharmacology - September 4, 2021 Category: Drugs & Pharmacology Authors: Satoru Mitsuboshi Ryohei Kaseda Ichiei Narita Source Type: research

Antibody-Mediated Rejection in Adult Liver Transplant Recipients: A Case Series and Literature Review
This study describes eight adult liver transplantation recipients who developed antibody-mediated rejection between 2002 and 2021 in our center, as well as a review of the literature on the reported cases of antibody-mediated rejection in liver transplantation recipients. Our center's medical records were reviewed retrospectively to extract the necessary data on patients' characteristics, management, and outcomes. Then, a comprehensive search using Embase, PubMed, Web of Science, Cochrane library, and Google Scholar databases was conducted without time limitation until June, 2021. Finally, a stepwise protocol was developed...
Source: The Journal of Clinical Pharmacology - September 4, 2021 Category: Drugs & Pharmacology Authors: Hananeh Baradaran Simin Dashti-Khavidaki Mohammad Taher Monavar Talebian Mohsen Nasiri-Toosi Ali Jafarian Source Type: research

Association between steroid use and nephropathy in patients who were administered a proton pump inhibitor: Analysis of the Japanese Adverse Event Report database
This study used the Japanese Adverse Drug Event Report database to investigate whether steroid use decreases the risk of nephropathy in patients who were administered a proton pump inhibitor (PPI). Disproportionality of kidney injury was observed between patients who did and those who did not use steroids while taking lansoprazole (reporting odds ratio [ROR]: 0.78, 95% confidence interval [CI]: 0.65-0.93; P = 0.002) or rabeprazole (ROR: 0.69, 95% CI: 0.53-0.89; P = 0.005). Multiple logistic regression analysis revealed a significantly negative association of kidney injury with steroid use (odds ratio [OR] 0.85, 95% CI 0.75...
Source: The Journal of Clinical Pharmacology - September 4, 2021 Category: Drugs & Pharmacology Authors: Satoru Mitsuboshi Ryohei Kaseda Ichiei Narita Source Type: research

Efficacy and Safety of Lasmiditan for Acute Treatment of Migraine in Adults: A Meta-Analysis
J Clin Pharmacol. 2021 Sep 2. doi: 10.1002/jcph.1962. Online ahead of print.ABSTRACTMonotherapy with triptans in acute migraine is ineffective in many patients and contraindicated in certain cardiovascular diseases where alternative therapeutic options are necessary to explore. This meta-analysis has evaluated the efficacy and safety of Lasmiditan for the treatment of acute migraine in adults. After performing literature search on MEDLINE/PubMed, Scopus, Cochrane databases and International Clinical Trial Registry Platform (ICTRP), reviewers assessed eligibility and extracted data from four relevant articles. PRISMA guidel...
Source: The Journal of Clinical Pharmacology - September 2, 2021 Category: Drugs & Pharmacology Authors: Rituparna Maiti Archana Mishra Haridas Mundot Puliappadamb Monalisa Jena Anand Srinivasan Source Type: research

Clinical outcome data of first cohort of chronic pain patients treated with cannabis-based sublingual oils in the United Kingdom - analysis from the UK Medical Cannabis Registry
This study aimed to investigate the health-related quality of life outcomes of patients with chronic pain who were prescribed CBMP oil preparations (Adven®, Curaleaf International) This study is a case-series of patients from the UK Medical Cannabis Registry, who were treated with CBMP oils for an indication of chronic pain. The primary outcomes were the changes in Brief Pain Inventory short-form (BPI), Short-form McGill Pain Questionnaire-2 (SF-MPQ-2), Visual Analogue Scale (VAS) Pain, General Anxiety Disorder-7 (GAD-7), Sleep Quality Scale (SQS), and EQ-5D-5L, at 1, 3, and 6 months. 110 patients were included. Signif...
Source: The Journal of Clinical Pharmacology - September 2, 2021 Category: Drugs & Pharmacology Authors: Michal Kawka Simon Erridge Carl Holvey Ross Coomber Azfer Usmani Mohammad Sajad Michael W Platt James J Rucker Mikael H Sodergren Source Type: research

Quetiapine-induced thyroid dysfunction: a systematic review
This article is protected by copyright. All rights reserved.PMID:34467533 | DOI:10.1002/jcph.1960 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - September 1, 2021 Category: Drugs & Pharmacology Authors: Mohamed Adil Shah Khoodoruth Ameen Khamis Abedalaziz Abdo Sami Ouanes Source Type: research

Fluoride Pharmacokinetics in Urine and Plasma Following Multiple Doses of MK-8507, an Investigational, Oral, Once-Weekly Non-Nucleoside Reverse Transcriptase Inhibitor
This article is protected by copyright. All rights reserved.PMID:34435371 | DOI:10.1002/jcph.1957 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 26, 2021 Category: Drugs & Pharmacology Authors: Gillian Gillespie Deanne Jackson Rudd Saijuan Zhang Andrea Schaeffer Charles Tomek Patrick Larson S Aubrey Stoch Marian Iwamoto Source Type: research

Population Pharmacokinetics and Exposure-Safety Relationships of Alisertib in Children and Adolescents With Advanced Malignancies
J Clin Pharmacol. 2021 Aug 25. doi: 10.1002/jcph.1958. Online ahead of print.ABSTRACTPopulation pharmacokinetic (PK) and exposure-safety analyses of alisertib were performed in children enrolled in two clinical trials: NCT024448841 and NCT01154816.2 NCT02444884 was a dose-finding study in children with relapsed/refractory solid malignancies (phase 1) or neuroblastomas (phase 2). Patients received oral alisertib 45-‍100 mg/m2 as powder-in-capsule once daily (QD) or twice daily (BID) for 7 days in 21-day cycles. Serial blood samples were collected up to 24 hours post-dose on cycle 1, day 1. NCT01154816 was a phase 2 sing...
Source: The Journal of Clinical Pharmacology - August 26, 2021 Category: Drugs & Pharmacology Authors: Xiaofei Zhou Diane R Mould Ying Yuan Elizabeth Fox Emily Greengard Douglas V Faller Karthik Venkatakrishnan Source Type: research

Fluoride Pharmacokinetics in Urine and Plasma Following Multiple Doses of MK-8507, an Investigational, Oral, Once-Weekly Non-Nucleoside Reverse Transcriptase Inhibitor
This article is protected by copyright. All rights reserved.PMID:34435371 | DOI:10.1002/jcph.1957 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 26, 2021 Category: Drugs & Pharmacology Authors: Gillian Gillespie Deanne Jackson Rudd Saijuan Zhang Andrea Schaeffer Charles Tomek Patrick Larson S Aubrey Stoch Marian Iwamoto Source Type: research

Population Pharmacokinetics and Exposure-Safety Relationships of Alisertib in Children and Adolescents With Advanced Malignancies
J Clin Pharmacol. 2021 Aug 25. doi: 10.1002/jcph.1958. Online ahead of print.ABSTRACTPopulation pharmacokinetic (PK) and exposure-safety analyses of alisertib were performed in children enrolled in two clinical trials: NCT024448841 and NCT01154816.2 NCT02444884 was a dose-finding study in children with relapsed/refractory solid malignancies (phase 1) or neuroblastomas (phase 2). Patients received oral alisertib 45-‍100 mg/m2 as powder-in-capsule once daily (QD) or twice daily (BID) for 7 days in 21-day cycles. Serial blood samples were collected up to 24 hours post-dose on cycle 1, day 1. NCT01154816 was a phase 2 sing...
Source: The Journal of Clinical Pharmacology - August 26, 2021 Category: Drugs & Pharmacology Authors: Xiaofei Zhou Diane R Mould Ying Yuan Elizabeth Fox Emily Greengard Douglas V Faller Karthik Venkatakrishnan Source Type: research

Fluoride Pharmacokinetics in Urine and Plasma Following Multiple Doses of MK-8507, an Investigational, Oral, Once-Weekly Non-Nucleoside Reverse Transcriptase Inhibitor
This article is protected by copyright. All rights reserved.PMID:34435371 | DOI:10.1002/jcph.1957 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 26, 2021 Category: Drugs & Pharmacology Authors: Gillian Gillespie Deanne Jackson Rudd Saijuan Zhang Andrea Schaeffer Charles Tomek Patrick Larson S Aubrey Stoch Marian Iwamoto Source Type: research

Population Pharmacokinetics and Exposure-Safety Relationships of Alisertib in Children and Adolescents With Advanced Malignancies
J Clin Pharmacol. 2021 Aug 25. doi: 10.1002/jcph.1958. Online ahead of print.ABSTRACTPopulation pharmacokinetic (PK) and exposure-safety analyses of alisertib were performed in children enrolled in two clinical trials: NCT024448841 and NCT01154816.2 NCT02444884 was a dose-finding study in children with relapsed/refractory solid malignancies (phase 1) or neuroblastomas (phase 2). Patients received oral alisertib 45-‍100 mg/m2 as powder-in-capsule once daily (QD) or twice daily (BID) for 7 days in 21-day cycles. Serial blood samples were collected up to 24 hours post-dose on cycle 1, day 1. NCT01154816 was a phase 2 sing...
Source: The Journal of Clinical Pharmacology - August 26, 2021 Category: Drugs & Pharmacology Authors: Xiaofei Zhou Diane R Mould Ying Yuan Elizabeth Fox Emily Greengard Douglas V Faller Karthik Venkatakrishnan Source Type: research

Fluoride Pharmacokinetics in Urine and Plasma Following Multiple Doses of MK-8507, an Investigational, Oral, Once-Weekly Non-Nucleoside Reverse Transcriptase Inhibitor
This article is protected by copyright. All rights reserved.PMID:34435371 | DOI:10.1002/jcph.1957 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 26, 2021 Category: Drugs & Pharmacology Authors: Gillian Gillespie Deanne Jackson Rudd Saijuan Zhang Andrea Schaeffer Charles Tomek Patrick Larson S Aubrey Stoch Marian Iwamoto Source Type: research

Population Pharmacokinetics and Exposure-Safety Relationships of Alisertib in Children and Adolescents With Advanced Malignancies
J Clin Pharmacol. 2021 Aug 25. doi: 10.1002/jcph.1958. Online ahead of print.ABSTRACTPopulation pharmacokinetic (PK) and exposure-safety analyses of alisertib were performed in children enrolled in two clinical trials: NCT024448841 and NCT01154816.2 NCT02444884 was a dose-finding study in children with relapsed/refractory solid malignancies (phase 1) or neuroblastomas (phase 2). Patients received oral alisertib 45-‍100 mg/m2 as powder-in-capsule once daily (QD) or twice daily (BID) for 7 days in 21-day cycles. Serial blood samples were collected up to 24 hours post-dose on cycle 1, day 1. NCT01154816 was a phase 2 sing...
Source: The Journal of Clinical Pharmacology - August 26, 2021 Category: Drugs & Pharmacology Authors: Xiaofei Zhou Diane R Mould Ying Yuan Elizabeth Fox Emily Greengard Douglas V Faller Karthik Venkatakrishnan Source Type: research

Fluoride Pharmacokinetics in Urine and Plasma Following Multiple Doses of MK-8507, an Investigational, Oral, Once-Weekly Non-Nucleoside Reverse Transcriptase Inhibitor
This article is protected by copyright. All rights reserved.PMID:34435371 | DOI:10.1002/jcph.1957 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 26, 2021 Category: Drugs & Pharmacology Authors: Gillian Gillespie Deanne Jackson Rudd Saijuan Zhang Andrea Schaeffer Charles Tomek Patrick Larson S Aubrey Stoch Marian Iwamoto Source Type: research

Population Pharmacokinetics and Exposure-Safety Relationships of Alisertib in Children and Adolescents With Advanced Malignancies
J Clin Pharmacol. 2021 Aug 25. doi: 10.1002/jcph.1958. Online ahead of print.ABSTRACTPopulation pharmacokinetic (PK) and exposure-safety analyses of alisertib were performed in children enrolled in two clinical trials: NCT024448841 and NCT01154816.2 NCT02444884 was a dose-finding study in children with relapsed/refractory solid malignancies (phase 1) or neuroblastomas (phase 2). Patients received oral alisertib 45-‍100 mg/m2 as powder-in-capsule once daily (QD) or twice daily (BID) for 7 days in 21-day cycles. Serial blood samples were collected up to 24 hours post-dose on cycle 1, day 1. NCT01154816 was a phase 2 sing...
Source: The Journal of Clinical Pharmacology - August 26, 2021 Category: Drugs & Pharmacology Authors: Xiaofei Zhou Diane R Mould Ying Yuan Elizabeth Fox Emily Greengard Douglas V Faller Karthik Venkatakrishnan Source Type: research

A Phase 1 Trial to Evaluate the Relationship Between Fluoride Intake and Urinary Fluoride Excretion in Healthy Participants
In conclusion, fluoride exposure was optimally assessed by urinary fluoride excretion in conjunction with strict dietary fluoride restrictions, as measurements were consistent and reproducible. This article is protected by copyright. All rights reserved.PMID:34432899 | DOI:10.1002/jcph.1956 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 25, 2021 Category: Drugs & Pharmacology Authors: Gillian Gillespie Deanne Jackson Rudd Saijuan Zhang Andrea Schaeffer Charles Tomek Patrick Larson S Aubrey Stoch Marian Iwamoto Source Type: research

A Multiple Logistic Regression Model based on Gamma Glutamyl Transferase as a Biomarker for Early Prediction of Drug-Induced Liver Injury in Vietnamese Patients
This article is protected by copyright. All rights reserved.PMID:34415063 | DOI:10.1002/jcph.1955 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 20, 2021 Category: Drugs & Pharmacology Authors: Phuong Nguyen Thi Thu Dung Hoang Van Khue Pham Minh Hoi Nguyen Thanh Source Type: research

A Multiple Logistic Regression Model based on Gamma Glutamyl Transferase as a Biomarker for Early Prediction of Drug-Induced Liver Injury in Vietnamese Patients
This article is protected by copyright. All rights reserved.PMID:34415063 | DOI:10.1002/jcph.1955 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 20, 2021 Category: Drugs & Pharmacology Authors: Phuong Nguyen Thi Thu Dung Hoang Van Khue Pham Minh Hoi Nguyen Thanh Source Type: research

A Multiple Logistic Regression Model based on Gamma Glutamyl Transferase as a Biomarker for Early Prediction of Drug-Induced Liver Injury in Vietnamese Patients
This article is protected by copyright. All rights reserved.PMID:34415063 | DOI:10.1002/jcph.1955 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 20, 2021 Category: Drugs & Pharmacology Authors: Phuong Nguyen Thi Thu Dung Hoang Van Khue Pham Minh Hoi Nguyen Thanh Source Type: research

A Multiple Logistic Regression Model based on Gamma Glutamyl Transferase as a Biomarker for Early Prediction of Drug-Induced Liver Injury in Vietnamese Patients
This article is protected by copyright. All rights reserved.PMID:34415063 | DOI:10.1002/jcph.1955 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 20, 2021 Category: Drugs & Pharmacology Authors: Phuong Nguyen Thi Thu Dung Hoang Van Khue Pham Minh Hoi Nguyen Thanh Source Type: research

A Multiple Logistic Regression Model based on Gamma Glutamyl Transferase as a Biomarker for Early Prediction of Drug-Induced Liver Injury in Vietnamese Patients
This article is protected by copyright. All rights reserved.PMID:34415063 | DOI:10.1002/jcph.1955 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 20, 2021 Category: Drugs & Pharmacology Authors: Phuong Nguyen Thi Thu Dung Hoang Van Khue Pham Minh Hoi Nguyen Thanh Source Type: research

Impact of switching on pharmacokinetics of therapeutic biologics and interchangeability assessment- a simulation study
This article is protected by copyright. All rights reserved.PMID:34411322 | DOI:10.1002/jcph.1954 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 19, 2021 Category: Drugs & Pharmacology Authors: Ping Ji Yupeng Ren Liang Li Sarah J Schrieber Dipak Pisal William Hallett Yaning Wang Chandrahas Sahajwalla Source Type: research

Impact of switching on pharmacokinetics of therapeutic biologics and interchangeability assessment- a simulation study
This article is protected by copyright. All rights reserved.PMID:34411322 | DOI:10.1002/jcph.1954 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 19, 2021 Category: Drugs & Pharmacology Authors: Ping Ji Yupeng Ren Liang Li Sarah J Schrieber Dipak Pisal William Hallett Yaning Wang Chandrahas Sahajwalla Source Type: research

Pharmacokinetics of Ipatasertib in Subjects With Hepatic Impairment Using Two Methods of Classification of Hepatic Function
This article is protected by copyright. All rights reserved.PMID:34402068 | DOI:10.1002/jcph.1941 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 17, 2021 Category: Drugs & Pharmacology Authors: Rucha Sane Vikram Malhi Dhruvitkumar S Sutaria Eunpi Cho Patrick Twomey Christopher Craggs Jianshuang Wang Adam Harris Luna Musib Source Type: research

Pharmacokinetics of Ipatasertib in Subjects With Hepatic Impairment Using Two Methods of Classification of Hepatic Function
This article is protected by copyright. All rights reserved.PMID:34402068 | DOI:10.1002/jcph.1941 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 17, 2021 Category: Drugs & Pharmacology Authors: Rucha Sane Vikram Malhi Dhruvitkumar S Sutaria Eunpi Cho Patrick Twomey Christopher Craggs Jianshuang Wang Adam Harris Luna Musib Source Type: research

Gabapentinoid Pharmacology in the Context of Emerging Misuse Liability
This article will review the epidemiology and pharmacology of gabapentinoids (gabapentin and pregabalin) relevant to their emerging misuse potential and provide guidance for clinical and regulatory management. Gabapentinoids are γ-aminobutyric acid analogues that produce their therapeutic effects by inhibiting voltage-gated calcium channels and decreasing neurotransmitter release. Recently gabapentinoid prescribing and use have increased tremendously. Although traditionally thought to possess a favorable safety profile, gabapentinoid misuse has also risen significantly. Gabapentinoid misuse generally occurs in combin...
Source: The Journal of Clinical Pharmacology - August 16, 2021 Category: Drugs & Pharmacology Authors: Kirk E Evoy Alyssa M Peckham Jordan R Covvey Kevin J Tidgewell Source Type: research

Drugs of Abuse: How Clinical Pharmacology Brings Clarity to the Shadows
J Clin Pharmacol. 2021 Aug;61 Suppl 2:S6-S9. doi: 10.1002/jcph.1921.NO ABSTRACTPMID:34396550 | DOI:10.1002/jcph.1921 (Source: The Journal of Clinical Pharmacology)
Source: The Journal of Clinical Pharmacology - August 16, 2021 Category: Drugs & Pharmacology Authors: Anne N Nafziger C Michael White Source Type: research

Sedative-Hypnotic Agents That Impact Gamma-Aminobutyric Acid Receptors: Focus on Flunitrazepam, Gamma-Hydroxybutyric Acid, Phenibut, and Selank
J Clin Pharmacol. 2021 Aug;61 Suppl 2:S114-S128. doi: 10.1002/jcph.1922.ABSTRACTThere are many nonopioid central nervous system depressant substances that share a gamma-aminobutyric acid (GABA) receptor-related mechanism of action. These sedatives-hypnotics can be indicated to treat anxiety, seizures, depression, and insomnia but are also used as substances of abuse and used to facilitate sexual assault. Barbiturates, methaqualone, and glutethimide were among the first type A GABA receptor-mediated sedative-hypnotics. Their clinical use was limited for most indications by serious adverse events and strong abuse potential b...
Source: The Journal of Clinical Pharmacology - August 16, 2021 Category: Drugs & Pharmacology Authors: Cassandra R Doyno C Michael White Source Type: research

Clinical Pharmacology, Toxicity, and Abuse Potential of Opioids
J Clin Pharmacol. 2021 Aug;61 Suppl 2:S70-S88. doi: 10.1002/jcph.1923.ABSTRACTOpioids were the most common drug class resulting in overdose deaths in the United States in 2019. Widespread clinical use of prescription opioids for moderate to severe pain contributed to the ongoing opioid epidemic with the subsequent emergence of fentanyl-laced heroin. More potent analogues of fentanyl and structurally diverse opioid receptor agonists such as AH-7921 and MT-45 are fueling an increasingly diverse illicit opioid supply. Overdose from synthetic opioids with high binding affinities may not respond to a typical naloxone dose, ther...
Source: The Journal of Clinical Pharmacology - August 16, 2021 Category: Drugs & Pharmacology Authors: David Vearrier Oliver Grundmann Source Type: research

Clinical Pharmacology of Electronic Nicotine Delivery Systems (ENDS): Implications for Benefits and Risks in the Promotion of the Combusted Tobacco Endgame
J Clin Pharmacol. 2021 Aug;61 Suppl 2:S18-S36. doi: 10.1002/jcph.1915.ABSTRACTElectronic nicotine delivery systems (ENDS) such as e-cigarettes and heated tobacco products are novel battery-operated devices that deliver nicotine without combustion of tobacco. Because cigarette smoking is sustained by nicotine addiction and the toxic combustion products are mainly responsible for the harmful effects of smoking, ENDS could be used to promote smoking cessation while exposing users to lower levels of toxicants compared with conventional cigarettes. The currently available evidence from clinical and observational studies indicat...
Source: The Journal of Clinical Pharmacology - August 16, 2021 Category: Drugs & Pharmacology Authors: Neal L Benowitz Gideon St Helen Evangelia Liakoni Source Type: research

The Epidemiology of Drug Abuse
J Clin Pharmacol. 2021 Aug;61 Suppl 2:S10-S17. doi: 10.1002/jcph.1937.ABSTRACTMany Americans use alcohol and recreational drugs. Some will develop substance use disorders that affect a person's brain and behavior, leading to continued use despite problems caused. We review the epidemiology of addiction in the United States, including changes in use patterns over time, highlighting rates in adolescents and young adults, as well as adults. An overview of the health and societal impacts of substance use is provided alongside the importance of multimodal, evidence-based treatment comprising psychosocial interventions and medic...
Source: The Journal of Clinical Pharmacology - August 16, 2021 Category: Drugs & Pharmacology Authors: Martha J Ignaszewski Source Type: research

Maternal Exposure and Neonatal Effects of Drugs of Abuse
J Clin Pharmacol. 2021 Aug;61 Suppl 2:S142-S155. doi: 10.1002/jcph.1928.ABSTRACTThe public health crisis of pregnant women being exposed to drugs of abuse and of its impact on their unborn children continues to grow at an alarming rate globally. The state of pregnancy is unique, with physiological changes that can lead to changes in the way drugs are handled by the body in both pharmacokinetics and response. These changes place the pregnant woman, fetus, and newborn infant at risk, as many of these drugs can cross the placenta and into breast milk. The substances most commonly linked to harmful effects include alcohol, tob...
Source: The Journal of Clinical Pharmacology - August 16, 2021 Category: Drugs & Pharmacology Authors: Jessica M Barry Angela K Birnbaum Lisa R Jasin Catherine M Sherwin Source Type: research