Results 21 to 30 of about 455 (133)

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

Journal of Pharmaceutical Sciences
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.
lanyan Fang, Frederico S Martins, Tausif Ahmed   +2 more
exaly   +4 more sources

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

Journal of Pharmaceutical Sciences, 2021
This report summarizes the proceedings for Day 3 of the workshop titled "Current State and Future Expectations of Translational Modeling Strategies toSupportDrug Product Development, Manufacturing Changes and Controls". From a drug product quality perspective, patient-centric product development necessitates the development of clinically relevant drug ...
Amitava, Mitra, Sandra, Suarez-Sharp, Xavier J H, Pepin, Talia, Flanagan, Yang, Zhao, Evangelos, Kotzagiorgis, Neil, Parrott, Satish, Sharan, Christophe, Tistaert, Tycho, Heimbach, Banu, Zolnik, Erik, Sjögren, Fang, Wu, Om, Anand, Shefali, Kakar, Min, Li, Shereeni, Veerasingham, Shinichi, Kijima, Gustavo Mendes, Lima Santos, Baoming, Ning, Kimberly, Raines, Greg, Rullo, Haritha, Mandula, Poonam, Delvadia, Jennifer, Dressman, Paul A, Dickinson, Andrew, Babiskin   +26 more
openaire   +3 more sources

The emerging role of physiologically-based pharmacokinetic/biopharmaceutics modeling in formulation development [PDF]

Arhiv za farmaciju, 2021
Computer-based (in silico) modeling & simulation tools have been embraced in different fields of pharmaceutics for a variety of applications. Among these, physiologically-based pharmacokinetic/biopharmaceutics modeling (PBPK/PBBM) emerged as a ...
Cvijić Sandra, Ignjatović Jelisaveta, Parojčić Jelena, Ibrić Svetlana   +3 more
doaj   +3 more sources

Physiologically Based Biopharmaceutics Modeling of Food Effect for Basmisanil: A Retrospective Case Study of the Utility for Formulation Bridging

Pharmaceutics, 2023
Basmisanil, is a lipophilic drug substance, exhibiting poor solubility and good permeability (BCS class 2). A validated physiologically based biopharmaceutics model (PBBM) has been previously described for tablets dosed in the fed state.
Tejashree Belubbi, Davide Bassani, Cordula Stillhart, Neil Parrott   +3 more
doaj   +2 more sources

Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report [PDF]

Molecular Pharmaceutics
Physiologically based biopharmaceutics modeling (PBBM) is used to elevate drug product quality by providing a more accurate and holistic understanding of how drugs interact with the human body. These models are based on the integration of physiological, pharmacological, and pharmaceutical data to simulate and predict drug behavior in vivo.
Sumit Arora, Xavier J H Pepin, James E Polli   +2 more
exaly   +4 more sources

Finger Vein Recognition Based on a Personalized Best Bit Map

Sensors, 2012
Finger vein patterns have recently been recognized as an effective biometric identifier. In this paper, we propose a finger vein recognition method based on a personalized best bit map (PBBM).
Yilong Yin, Xiaoming Xi, Gongping Yang
doaj   +2 more sources

Application of New Approach Methodologies to Improve Oral Biopharmaceutic Assessments [PDF]

Pharmaceutics
Background/Objectives: The rapid expansion of New Approach Methodologies (NAMs) is transforming oral biopharmaceutics by offering mechanistically rich, human-relevant tools that can reduce reliance on animal testing while improving translational ...
Mauricio A. García, Miguel Ángel Cabrera-Pérez, Pablo M. González, Alexis Aceituno, Daniel Hachim   +4 more
doaj   +2 more sources

Integrating In Vitro BE Checker with In Silico Physiologically Based Biopharmaceutics Modeling to Predict the Pharmacokinetic Profiles of Oral Drug Products [PDF]

Pharmaceutics
Objective: The objective of this study was to develop a Physiologically Based Biopharmaceutics Modeling (PBBM) framework that can predict PK profiles in humans based on data generated from the BE Checker.
Takuto Niino, Takato Masada, Toshihide Takagi, Makoto Kataoka, Hiroyuki Yoshida, Shinji Yamashita, Atsushi Kambayashi   +6 more
doaj   +2 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

In Vitro–In Silico Approach in the Development of Clopidogrel Solid Dispersion Formulations [PDF]

Bioengineering
The aim of this study was to investigate the influence of solid dispersion (SD) formulation factors on improvement of the bioavailability and pharmacokinetic profile of clopidogrel after peroral administration using an in vitro–in silico approach.
Ehlimana Osmanović Omerdić, Sandra Cvijić, Jelisaveta Ignjatović, Branka Ivković, Dragana Vasiljević   +4 more
doaj   +2 more sources