Results 41 to 50 of about 1,970 (208)
AAPS OpenThis paper examines the standardization of bioequivalence (BE) administration methods for chewable tablets and other dosage forms instructing chewing in alignment for generic drug development.
Hye Lim Lim +4 more
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In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products
CPT: Pharmacometrics & Systems Pharmacology, 2019 The development of generic, single‐entity, drug–device combination products for orally inhaled drug products is challenging in part because of the complex nature of device design characteristics and the difficulties associated with establishing ...
Ross L. Walenga +2 more
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CPT: Pharmacometrics & Systems Pharmacology, 2023 This report summarizes the proceedings for day 2 sessions 1 and 3 of the 2‐day public workshop entitled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches,” a jointly sponsored workshop by the US Food and Drug ...
Fang Wu +17 more
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Annals of Clinical and Translational Neurology, EarlyView.ABSTRACT Multisystemic smooth muscle dysfunction syndrome (MSMDS) is an ultra‐rare, ACTA2‐related disorder characterized by severe cerebrovascular disease, aortic aneurysms, and smooth muscle dysfunction. Using molecular dynamics simulations and in silico drug screening, we identified that sapropterin dihydrochloride (Kuvan) is a candidate capable of ...
Moran Hausman‐Kedem +9 more
wiley +1 more source
Advanced Functional Materials, EarlyView.A swelling‐programmed micropatterned hydrogel guides adherent cells through a controlled transition from cell–matrix anchoring to cadherin‐mediated cell–cell compaction, enabling rapid assembly of high‐viability spheroids with defined size and morphology.
Han Gyeol Nam +8 more
wiley +1 more source
Advanced Functional Materials, EarlyView.Oligomerizing Pluronic triblock copolymers provides a processing strategy for tuning the mechanical properties and stimuli‐responsive behaviors of micellar hydrogels. Varying oligomer fraction produces hydrogels spanning brittle to highly extensible responses; maintaining micellar architectures enables cooling‐induced reverse thermal shape memory and ...
Gourav Kumbhojkar +8 more
wiley +1 more source
Evaluation of model‐based bioequivalence approach for single sample pharmacokinetic studies
CPT: Pharmacometrics & Systems Pharmacology, 2023 In a traditional pharmacokinetic (PK) bioequivalence (BE) study, a two‐way crossover study is conducted, PK parameters (namely the area under the time‐concentration curve [AUC] and the maximal concentration [Cmax]) are obtained by noncompartmental ...
Coralie Tardivon +10 more
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Advanced Functional Materials, EarlyView.Low‐frequency noise spectroscopy defines the resolvable conductance states of synaptic FeFETs by coupling read‐current fluctuation with usable dynamic range. The resulting noise‐limited bit precision establishes a universal, device‐agnostic reliability metric beyond the memory window, enabling quantitative benchmarking and rational design of high ...
Jaehong Park +12 more
wiley +1 more source
Advanced Materials, EarlyView.The water permeability of amorphous carbon dots (CDs) is demonstrated by investigating their plasticization. Novel polyamide‐based and amorphous nanoparticles are synthesized by controlling their inner packing density. Water plasticization is evidenced by the decrease of the CDs glass transition temperature with increasing the hydration degree.
Elisa Sturabotti +8 more
wiley +1 more source
CPT: Pharmacometrics & Systems PharmacologyProton pump inhibitors (PPIs) can affect the release of drugs from their dosage forms in vivo by elevating the gastric pH. Our recent clinical study has demonstrated that drug–drug interactions (DDIs) exist between a PPI, omeprazole, and nifedipine ...
Ming‐Liang Tan +6 more
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