Results 21 to 30 of about 826 (178)

Integrated biopharmaceutical approach in pharmaceutical development and drug characterization: General concept and application [PDF]

Hemijska Industrija, 2020
The importance of biopharmaceutical considerations in pharmaceutical development and drug characterization has been well recognized both by pharmaceutical industry and regulatory authorities as a tool to establish predictive relationships ...
Cvijić Sandra V., Ibrić Svetlana R., Parojčić Jelena V.   +2 more
doaj   +3 more sources

The Provisional No-Effect Threshold of Sugar Alcohols on Oral Drug Absorption Estimated by Physiologically Based Biopharmaceutics Model [PDF]

Journal of Pharmaceutical Sciences, 2021
Sugar alcohols reduce oral drug bioavailability by osmotic effects, but the magnitude of these effects differs among different drugs. This study aimed to identify the drug-related critical attributes of osmotic effects and estimate the impact of a "practical" sugar alcohol dose on the pharmacokinetics of various molecules using modeling and simulation ...
Kazuki Matsui
exaly   +3 more sources

Model-Integrated Bioequivalence (MIBE) in Generic Drug Research: Can We Ease the Bioequivalence Burden? [PDF]

Pharmaceutics
Bioequivalence (BE) studies are essential to file an abbreviated new drug application (ANDA) against an innovator drug product. Conventional BE studies can be complex, time-consuming, and operationally challenging, particularly for products with long ...
Sivacharan Kollipara, Rajkumar Boddu, Chandra Teja Uppuluri, Anuj Kumar Saini   +3 more
doaj   +2 more sources

Emerging perspectives on leveraging physiologically based biopharmaceutics modeling (PBBM) for BCS class III biowaivers: A webinar summary. [PDF]

J Pharm Sci
The regulatory framework for Biopharmaceutics Classification System (BCS) class III drug products provides a pathway for streamlined biowaivers in drug development, eliminating the need for expensive and time-consuming bioavailability and bioequivalence studies while maintaining quality standards.
Fang L, Veerasingham S, Xu Y, Garcia-Arieta A, Kollipara S, Kanagasabapathy Y, Ahmed T, Martins FS, Suarez-Sharp S.   +8 more
europepmc   +3 more sources

DoE- and PBBM-Driven Formulation Development of an Extended-Release Donepezil Tablet [PDF]

Pharmaceuticals
Background/Objectives: This study explores the integration of Design of Experiments (DoE) with Physiologically Based Biopharmaceutics Modeling (PBBM) to streamline the development of extended-release (XR) formulations.
Frederico Severino Martins, Leonardo Luiz Borges, Sivacharan Kollipara, Praveen Sivadasu, Renê Oliveira do Couto   +4 more
doaj   +2 more sources

Evaluating the Impact of Physiological Properties of the Gastrointestinal Tract On Drug In Vivo Performance Using Physiologically Based Biopharmaceutics Modeling and Virtual Clinical Trials [PDF]

Journal of Pharmaceutical Sciences, 2021
The physiological properties of the gastrointestinal tract, such as pH, fluid volume, bile salt concentration, and gastrointestinal transit time, are highly variable in vivo. These properties can affect the dissolution and absorption of a drug, depending on its properties and formulation.
Rebeka Jereb, Aleksander Bajc
exaly   +3 more sources

Approaches to Account for Colon Absorption in Physiologically Based Biopharmaceutics Modeling of Extended-Release Drug Products

Molecular Pharmaceutics, 2023
The rate and extent of colon absorption are important determinants of the in vivo performance of extended-release (ER) drug products. The ability to appropriately predict this at different stages of development using mechanistic physiologically based biopharmaceutic modeling (PBBM) is highly desirable.
Harshad Jadhav, Patrick Augustijns, Christer Tannergren   +2 more
exaly   +3 more sources

Comparison of Compartmental and Non-Compartmental Analysis to Detect Biopharmaceutical Similarity of Intravenous Nanomaterial-Based Rifabutin Formulations

Pharmaceutics, 2023
Pharmacometric analysis is often used to quantify the differences and similarities between formulation prototypes. In the regulatory framework, it plays a significant role in the evaluation of bioequivalence.
Nadezhda Osipova, Andrey Budko, Olga Maksimenko, Elena Shipulo, Ludmila Vanchugova, Wenqian Chen, Svetlana Gelperina, Matthias G. Wacker   +7 more
doaj   +2 more sources

In Silico Evaluation of the Biopharmaceutical and Pharmacokinetic Behavior of Metronidazole from Coated Colonic Release Matrix Tablets [PDF]

Pharmaceutics
Background: Physiologically based biopharmaceutics modeling (PBBM) models can help to predict drug release and in vivo absorption behaviors. Colon drug delivery systems have gained interest over the past few years due to the advantages they provide in ...
Roberto Arévalo-Pérez, Cristina Maderuelo, José M. Lanao   +2 more
doaj   +2 more sources

Model‐Informed Drug Development of a Sustained Release Formulation of Flucytosine in the Treatment of Cryptococcal Meningitis: A Case Study Using Physiologically Based Pharmacokinetic Modeling [PDF]

CPT: Pharmacometrics & Systems Pharmacology
This paper presents a case study demonstrating the application of model‐informed drug development (MIDD) and early modeling integration in the development of a sustained release (SR) formulation of flucytosine for cryptococcal meningoencephalitis (CM) in
Johanna Eriksson, Erik Sjögren, Jean‐Yves Gillon, Henri Caplain, Vishal Goyal, Vijay Satam, Stephen Robinson, Isabela Ribeiro, Marylore Chenel   +8 more
doaj   +2 more sources