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A 2024 Update on US FDA Implementation of Partial Area Under the Curve Into Bioavailability and Bioequivalence Assessments.
Clin Pharmacol Ther
January 2025
Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Comparisons of maximum drug concentration (C) and total area under the concentration vs. time curve (AUC) may be inadequate for bioavailability (BA)/bioequivalence (BE) assessments in cases where the shape of the pharmacokinetic (PK) profile of a drug impacts the clinical performance. In such cases, partial area under the concentration vs.
View Article and Find Full Text PDFNovel methotrexate long-acting system using ambroxol coating and hydroxypropyl methylcellulose encapsulation for preferential and enhanced lung cancer efficiency.
PLoS One
January 2025
The National Centre of Vaccines and Bioprocessing, King Abdulaziz City for Science and Technology (KACST), Riyadh, Saudi Arabia.
Methotrexate (MTX) is classified as an antimetabolite. It's commonly used to treat lung cancer. MTX is an immunosuppressant following the above-mentioned mechanism of action due to its poor selectivity.
View Article and Find Full Text PDFComparison of RT-qPCR With Branched DNA to Quantify a Lipid Nanoparticle-Encapsulated mRNA Therapeutic in Serum and Liver Tissue Samples From Nonclinical PK Studies.
AAPS J
January 2025
Moderna, Inc., Cambridge, Massachusetts, USA.
While the branched DNA (bDNA) assay is an established bioanalytical method for measurement of lipid nanoparticle (LNP)-encapsulated messenger RNA (mRNA) pharmacokinetic parameters, reverse transcription-quantitative polymerase chain reaction (RT-qPCR) has been considered as an alternative platform. RT-qPCR and bDNA platforms were compared for sensitivity, specificity, correlation, and overall assay performance using serum and tissue samples from 2 nonclinical mouse studies of a therapeutic mRNA candidate, LNP-PAH-mRNA, which encodes for human phenylalanine hydroxylase enzyme. Pharmacokinetic parameter noncompartmental analysis was completed using Phoenix WinNonlin.
View Article and Find Full Text PDFPharmacokinetic exposure and treatment outcomes of lenvatinib in patients with renal cell carcinoma and differentiated thyroid carcinoma.
Cancer Chemother Pharmacol
January 2025
Department of Pharmacy & Pharmacology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek, Amsterdam, The Netherlands.
Purpose: After initial approval of lenvatinib for radioiodine-refractory differentiated thyroid cancer (DTC), it has also shown promising outcomes in among others metastatic renal cell carcinoma (mRCC). Given that trial populations typically do not represent routine clinical care populations, questions arise about how applicable trial outcomes are in clinical practice. This study aims to compare the pharmacokinetics (PK), toxicity patterns, and survival data of lenvatinib in a real-world cohort with DTC and mRCC to those observed in pivotal clinical trials.
View Article and Find Full Text PDFPreclinical evaluation of Ga-labeled folic acid conjugates for visualization of inflammatory foci.
Nucl Med Biol
January 2025
State Research Center-Burnasyan Federal Medical Biophysical Center of Federal Medical Biological Agency, 123182 Moscow, Russia. Electronic address:
Introduction: Folate receptors (FR) have been considered a convenient target for different radiopharmaceuticals in recent years. Multifarious Ga-labeled folate conjugates have been proposed as promising agents for the PET imaging of FR-overexpressing malignant neoplasms. In addition, radiolabeled folate-based conjugates can be effective for imaging non-tumor pathological foci characterized by a pronounced cluster of activated macrophages.
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