Results 31 to 40 of about 1,092 (147)

Model-Informed Paradigm in Drug Development-An End-To-End Case Study From Upadacitinib Development. [PDF]

Clin Transl Sci
ABSTRACT Model‐informed drug development (MIDD) entails applying quantitative approaches to assist with decision‐making during drug development and has been used for dose optimization, to inform clinical trial design, and to support clinical trial waivers.
Bhatnagar S, Stodtmann S, Qian Y, Marroum P, Liu W, Mohamed MF.   +5 more
europepmc   +2 more sources

One and Two-Step In Vitro-In Vivo Correlations Based on USP IV Dynamic Dissolution Applied to Four Sodium Montelukast Products

Pharmaceutics, 2021
Montelukast is a weak acid drug characterized by its low solubility in the range of pH 1.2 to 4.5, which may lead to dissolution-limited absorption. The aim of this paper is to develop an in vivo predictive dissolution method for montelukast and to check
Mercedes Prieto-Escolar, Juan J. Torrado, Covadonga Álvarez, Alejandro Ruiz-Picazo, Marta Simón-Vázquez, Carlos Govantes, Jesús Frias, Alfredo García-Arieta, Isabel Gonzalez-Alvarez, Marival Bermejo   +9 more
doaj   +1 more source

On Absorption Modeling and Food Effect Prediction of Rivaroxaban, a BCS II Drug Orally Administered as an Immediate-Release Tablet

Pharmaceutics, 2021
The present work evaluates the food effect on the absorption of rivaroxaban (Riva), a BCS II drug, from the orally administered commercial immediate-release tablet (Xarelto IR) using physiologically based pharmacokinetic (PBPK) and conventional in vitro ...
Varun Kushwah, Sumit Arora, Miklós Tamás Katona, Dattatray Modhave, Eleonore Fröhlich, Amrit Paudel   +5 more
doaj   +1 more source

In vitro – in vivo correlation of intranasal drug deposition

, 2021
International audienceIn vitro – in vivo correlation (IVIVC) allows prediction of in vivo drug deposition from a nasally inhaled drug based on in vitro drug measurements. In vitro measurements include physical particle characterization and, more recently,
S. Le Guellec, Le Guellec, S., Vecellio, L., L. Vecellio, Ehrmann, S., S. Ehrmann   +5 more
core   +1 more source

Brain targeted delivery of paclitaxel using endogenous ligand

Asian Journal of Pharmaceutical Sciences, 2016
The objective of the present investigation was to formulate nanoparticles constructed using PLGA polymer for the effective targeted delivery to brain via nasal route.
Sanjeev R. Acharya, Padmanabha R.V. Reddy   +1 more
doaj   +1 more source

Recent Progress in Drug Release Testing Methods of Biopolymeric Particulate System

Pharmaceutics, 2021
Biopolymeric microparticles have been widely used for long-term release formulations of short half-life chemicals or synthetic peptides. Characterization of the drug release from microparticles is important to ensure product quality and desired ...
Yejin Kim, Eun Ji Park, Tae Wan Kim, Dong Hee Na   +3 more
doaj   +1 more source

IVIVC assessment, pharmacokinetic evaluation, and X-ray radiography mapping of Novel Parteck® SRP 80 and hypromellose-loaded LTD4 receptor antagonist chronosystem

Future Journal of Pharmaceutical Sciences, 2023
Background The current research aims to determine the pharmacokinetic parameters, mucoadhesive strength, and IVIVC correlation of the novel chronotherapeutic drug delivery system of montelukast sodium (MTS) loaded Parteck® SRP80 and hypromellose system ...
Saniya Jawed, C. S. Satish
doaj   +1 more source

Revisiting Supersaturation of a Biopharmaceutical Classification System IIB Drug: Evaluation via a Multi-Cup Dissolution Approach and Molecular Dynamic Simulation

Molecules, 2023
As a subclass of the biopharmaceutical classification system (BCS) class II, basic drugs (BCS IIB) exhibit pH-dependent solubility and tend to generate supersaturation in the gastrointestinal tract, leading to less qualified in vitro–in vivo correlation (
Yanxiong Gan, Yaxin Xu, Xue Zhang, Huiling Hu, Wenke Xiao, Zheng Yu, Tao Sun, Jinming Zhang, Chuanbiao Wen, Shichao Zheng   +9 more
doaj   +1 more source

In Vitro–In Vivo Correlations (IVIVC) for Predicting the Clinical Performance of Metronidazole Topical Creams Intended for Local Action

Pharmaceutics, 2023
The safety and efficacy of a generic medicine can be confirmed by demonstrating bioequivalence (BE) between the generic product and its reference listed drug (RLD) by measuring drug concentrations in the blood following administration.
Seeprarani Rath, Isadore Kanfer
doaj   +1 more source

IVIVC from Long Acting Olanzapine Microspheres

International Journal of Biomaterials, 2014
In this study, four PLGA microsphere formulations of Olanzapine were characterized on the basis of their in vitro behavior at 37°C, using a dialysis based method, with the goal of obtaining an IVIVC.
Susan D'Souza, Jabar A. Faraj, Stefano Giovagnoli, Patrick P. DeLuca   +3 more
doaj   +1 more source