Time-Varying Clearance in Milrinone Pharmacokinetics from Premature Neonates to Adolescents
ConclusionMilrinone is predominately renally eliminated and so renal function is an important covariate describing variability in clearance. Increasing clearance over time likely reflects increasing cardiac output and renal perfusion due to milrinone and return to baseline following CPB. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - April 13, 2024 Category: Drugs & Pharmacology Source Type: research
Clinical Pharmacology of the Antibody –Drug Conjugate Enfortumab Vedotin in Advanced Urothelial Carcinoma and Other Malignant Solid Tumors
The objectives of this review are to summarize the clinical pharmacology of enfortumab vedotin monotherapy and demonstrate that the appropriate dose has been selected for clinical use. Pharmacokinetics (PK) of enfortumab vedotin (antibody–drug conjugate and total antibody) and free MMAE were evaluated in five clinical trials of patients with locally advanced or metastatic urothelial carcinoma (n = 748). Intravenous enfortumab vedotin 0.5–1.25 mg/kg on days 1, 8, and 15 of a 28-day cycle showed linear, dose-proportional PK. No significant differences in exposure or safety of enfortumab vedotin and free MMAE were obser...
Source: Clinical Pharmacokinetics - April 12, 2024 Category: Drugs & Pharmacology Source Type: research
Pharmacokinetics of Monoclonal Antibodies Throughout Pregnancy: A Systematic Literature Review
ConclusionAvailable information suggests that the anatomical and physiological changes throughout pregnancy may have meaningful effects on the PK of mAbs. For most mAbs (not IFX), modestly higher dosing (per mg) maybe needed during pregnancy to sustain a similar serum exposure compared to pre-pregnancy. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - April 7, 2024 Category: Drugs & Pharmacology Source Type: research
Tacrolimus Variability and Clinical Outcomes in the Early Post-lung Transplantation Period: Oral Versus Continuous Intravenous Administration
ConclusionsAdministering tacrolimus orally directly after LuTx leads to a higher variability in blood concentrations compared to intravenous administration. There was no difference in the occurrence of AKI or transplant rejection. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - April 6, 2024 Category: Drugs & Pharmacology Source Type: research
Population Pharmacokinetics of Sacituzumab Govitecan in Patients with Metastatic Triple-Negative Breast Cancer and Other Solid Tumors
ConclusionsThese analyses support the approved SG dosing regimen of 10 mg/kg as intravenous infusion on days 1 and 8 of 21-day cycles and did not identify a need for dose adjustment based on evaluated covariates or disease characteristics. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - April 5, 2024 Category: Drugs & Pharmacology Source Type: research
Relative Bioavailability of Dolutegravir (DTG) and Emtricitabine/Tenofovir Alafenamide Fumarate (F/TAF) Administered as Paediatric Tablet Formulations in Healthy Volunteers
ConclusionsAlthough TAF AUC andCmax 90% CIs fell outside the pre-defined criteria (0.62 –1.11 and 0.65–1.01, respectively), no consistent effect on TAF PK was observed, likely due to high inter-subject variability. Moreover, there are several reasons to rely on TFV exposure as being more clinically relevant than TAF exposure. Therefore, we found no clinically relevant interactions in this study. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - April 4, 2024 Category: Drugs & Pharmacology Source Type: research
Comment on “Population Pharmacokinetics of Total and Unbound Isavuconazole in Critically Ill Patients: Implications for Adaptive Dosing Strategies” and “High Variability in Isavuconazole Unbound Fraction in Clinical Practice: A Call to Reconsider Pharmacokinetic/Pharmacodynamic Targets and Breakpoints”
(Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - April 4, 2024 Category: Drugs & Pharmacology Source Type: research
Relative Bioavailability of Dolutegravir (DTG) and Emtricitabine/Tenofovir Alafenamide Fumarate (F/TAF) Administered as Paediatric Tablet Formulations in Healthy Volunteers
ConclusionsAlthough TAF AUC andCmax 90% CIs fell outside the pre-defined criteria (0.62 –1.11 and 0.65–1.01, respectively), no consistent effect on TAF PK was observed, likely due to high inter-subject variability. Moreover, there are several reasons to rely on TFV exposure as being more clinically relevant than TAF exposure. Therefore, we found no clinically relevant interactions in this study. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - April 4, 2024 Category: Drugs & Pharmacology Source Type: research
Comment on “Population Pharmacokinetics of Total and Unbound Isavuconazole in Critically Ill Patients: Implications for Adaptive Dosing Strategies” and “High Variability in Isavuconazole Unbound Fraction in Clinical Practice: A Call to Reconsider Pharmacokinetic/Pharmacodynamic Targets and Breakpoints”
(Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - April 4, 2024 Category: Drugs & Pharmacology Source Type: research
Have We Neglected to Study Target-Site Drug Exposure in Children? A Systematic Review of the Literature
ConclusionThe influence of growth and development on drug tissue distribution continues to be a knowledge gap, due to the paucity of tissue PK data in children, especially in the younger age categories. Future research in this field should be encouraged as techniques to safely investigate drug tissue disposition in children are available. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - March 29, 2024 Category: Drugs & Pharmacology Source Type: research
Personalized Antifungal Therapy Through Model-Informed Precision Dosing of Posaconazole
ConclusionWe validated an MIPD strategy for posaconazole for its fit-for-purpose. Thereby, this study is an important first step towards MIPD-supported posaconazole dosage optimization with the goal to improve antifungal treatment in clinical practice. (Source: Clinical Pharmacokinetics)
Source: Clinical Pharmacokinetics - March 26, 2024 Category: Drugs & Pharmacology Source Type: research
