The development and validation of ligand binding assays used in the support of pharmacokinetic studies has been the focus of various workshops and publications in recent years, all in an effort to establish a guidance document for standardization of these bioanalytical methods. This summary report of the workshop from 2003 focuses on the issues discussed in presentations and notes points of discussion and areas of consensus among the participants.
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http://dx.doi.org/10.1007/s11095-005-5917-9 | DOI Listing |
BAY 2413555 is a novel selective and reversible positive allosteric modulator of the type 2 muscarinic acetylcholine (M2) receptor, aimed at enhancing parasympathetic signaling and restoring cardiac autonomic balance for the treatment of heart failure (HF). This study tested the safety, tolerability and pharmacokinetics of this novel therapeutic option. REMOTE-HF was a multicenter, double-blind, randomized, placebo-controlled, phase Ib dose-titration study with two active arms.
View Article and Find Full Text PDFHere we report results of a phase 1 multi-institutional, open-label, dose-escalation trial (NCT02744287) of BPX-601, an investigational autologous PSCA-directed GoCAR-T® cell product containing an inducible MyD88/CD40 ON-switch responsive to the activating dimerizer rimiducid, in patients with metastatic pancreatic (mPDAC) or castration-resistant prostate cancer (mCRPC). Primary objectives were to evaluate safety and tolerability and determine the recommended phase 2 dose/schedule (RP2D). Secondary objectives included the assessment of efficacy and characterization of the pharmacokinetics of rimiducid.
View Article and Find Full Text PDFFront Pharmacol
December 2024
ADVITOS GmbH, Munich, Germany.
Background: Acute kidney injury (AKI) requiring continuous renal replacement therapy is common in critically ill patients. The ADVanced Organ Support (ADVOS) system is a novel hemodialysis machine that uses albumin enriched dialysate which allows the removal of protein-bound toxins and drugs. To date, data on antimicrobial removal under ADVOS has not yet been reported.
View Article and Find Full Text PDFACS Cent Sci
December 2024
Physical and Life Sciences Directorate, Biosciences and Biotechnology Division, Global Security Directorate, Forensic Science Center, and Materials Science Division, Lawrence Livermore National Laboratory, Livermore, California 94550, United States.
Subetadex-α-methyl (SBX-Me), a modified, polyanionic cyclodextrin scaffold, has been evaluated for its utilization as a medical countermeasure (MCM) to neutralize the effects of fentanyl and related opioids. Initial toxicity assays demonstrate that SBX-Me has a nontoxic profile, comparable to the FDA-approved cyclodextrin-based drug Sugammadex. Pharmacokinetic analysis showed rapid clearance of SBX-Me with an elimination half-life of ∼7.
View Article and Find Full Text PDFCureus
November 2024
Vascular Surgery, University of Colorado Anschutz Medical Center, Colorado, USA.
Fluoroquinolones (FQs) are a widely prescribed class of antibiotics including ciprofloxacin, levofloxacin, and ofloxacin. They are commonly used to treat a variety of infections worldwide. Known for their broad-spectrum antimicrobial activity, as well as excellent pharmacokinetics and bioavailability, the use of FQs has risen significantly.
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