Results 31 to 40 of about 26,646 (226)

A Multicenter Randomized Bioequivalence Study of a Novel Ready-to-Use Temozolomide Oral Suspension vs. Temozolomide Capsules

open access: yesPharmaceutics, 2023
Background: Temozolomide (TMZ) oral suspension (Ped-TMZ, KIZFIZO®) is being developed for the treatment of relapsed or refractory neuroblastoma, a rare cancer affecting infants and young children.
François Ducray   +11 more
doaj   +1 more source

A SURVEY OF THE LIKELIHOOD APPROACH TO BIOEQUIVALENCE TRIALS [PDF]

open access: yes, 2007
Bioequivalence trials are abbreviated clinical trials whereby a generic drug or new formulation is evaluated to determine if it is equivalent to a corresponding previously approved brand-name drug or formulation.
Caffo, Brian S.   +2 more
core   +2 more sources

Toward Predictable Nanomedicine: Current Forecasting Frameworks for Nanoparticle–Biology Interactions

open access: yesAdvanced Intelligent Discovery, EarlyView.
Predictive models successfully screen nanoparticles for toxicity and cellular uptake. Yet, complex biological dynamics and sparse, nonstandardized data limit their accuracy. The field urgently needs integrated artificial intelligence/machine learning, systems biology, and open‐access data protocols to bridge the gap between materials science and safe ...
Mariya L. Ivanova   +4 more
wiley   +1 more source

Pharmacokinetic Simulation and Area under the Curve Estimation of Drugs Subject to Enterohepatic Circulation

open access: yesPharmaceutics
Enterohepatic circulation (EHC) is a complex process where drugs undergo secretion and reabsorption from the intestinal lumen multiple times, resulting in pharmacokinetic profiles with multiple peaks.
Melchor Alpízar   +4 more
doaj   +1 more source

Autonomous AI‐Driven Design for Skin Product Formulations

open access: yesAdvanced Intelligent Discovery, EarlyView.
This review presents a comprehensive closed‐loop framework for autonomous skin product formulation design. By integrating artificial intelligence‐driven experiment selection with automated multi‐tiered assays, the approach shifts development from trial‐and‐error to intelligent optimisation.
Yu Zhang   +5 more
wiley   +1 more source

Non-equivalence of antibiotic generic drugs and risk for intensive care patients [PDF]

open access: yes, 2013
Background: The underlying axiom in applying generic drugs is the equivalence of their active ingredient with the (usually more expensive) innovator product, an all-embracing statement with the insidious result that physicians assume that the generic ...
Barbeck, Mike   +4 more
core  

Early detection of biochemically occult autonomous thyroid nodules [PDF]

open access: yes, 2016
Objective: Autonomously functioning thyroid areas may be associated with subclinical or overt hyperthyroidism, but may exist even in the presence of normal TSH.
Brusca, Nunzia   +7 more
core   +1 more source

MicroRNA: unveiling novel mechanistic and theranostic pathways in diabetic cardiomyopathy

open access: yesFrontiers in Pharmacology
Diabetic cardiomyopathy (DCM) is a prominent contributor to morbidity and mortality in people with diabetes worldwide. In diabetic patients, it is a chronic condition that is characterized by ventricular hypertrophy (VH), diastolic dysfunction ...
Akash De   +7 more
doaj   +1 more source

Predictive Potential of Cmax Bioequivalence in Pilot Bioavailability/Bioequivalence Studies, through the Alternative ƒ2 Similarity Factor Method

open access: yesPharmaceutics, 2023
Pilot bioavailability/bioequivalence (BA/BE) studies are downsized trials that can be conducted prior to the definitive pivotal trial. In these trials, 12 to 18 subjects are usually enrolled, although, in principle, a sample size is not formally ...
Sara Carolina Henriques   +3 more
doaj   +1 more source

A phase 1 evaluation of inhaled oxytocin: Physiologically‐based pharmacokinetic model informed dosing of a novel heat‐stable oxytocin delivery system

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim To develop and validate a physiologically‐based pharmacokinetic (PBPK) model enabling inhaled oxytocin dose selection for clinical evaluation. Subsequently, to conduct a phase 1 study investigating the pharmacokinetics and safety of selected doses of an optimized inhaled oxytocin product in healthy, non‐pregnant female participants.
Pete Lambert   +6 more
wiley   +1 more source

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