Results 101 to 110 of about 278 (111)

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   +2 more sources

Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies

Journal of Pharmaceutical Sciences, 2021
For oral drug products, in vitro dissolution is the most used surrogate of in vivo dissolution and absorption. In the context of drug product quality, safe space is defined as the boundaries of in vitro dissolution, and relevant quality attributes, within which drug product variants are expected to be bioequivalent to each other.
Tycho Heimbach, Christophe Tistaert, Martin Mueller-Zsigmondy   +2 more
exaly   +3 more sources

Utility of Physiologically Based Biopharmaceutics Modeling (PBBM) in Regulatory Perspective: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space

Journal of Pharmaceutical Sciences, 2022
Product DRL is a generic IR tablet formulation with BCS Class-III API, available in two strengths: 50mg & 100mg. The reference and test formulations have salt-A & salt-B of API but both products were bioequivalent based on the in vivo bioequivalence study conducted for higher strength 100mg. While leveraging the generic product to different market, the
Adithya Karthik Bhattiprolu, Sivacharan Kollipara, Tausif Ahmed, Rajkumar Boddu, Siddharth Chachad   +4 more
openaire   +2 more sources

Role of Physiologically Based Biopharmaceutics Modeling (PBBM) in Fed Bioequivalence Study Waivers: Regulatory Outlook, Case Studies and Future Perspectives

Journal of Pharmaceutical Sciences
Over the past few decades, physiologically based biopharmaceutics modeling (PBBM) has demonstrated its utility in both new drug and generic product development. Applications of PBBM for fed bioequivalence study waivers is an upcoming area. Recently Innovation & Quality (IQ) consortium demonstrated utility of PBBM to avoid repeat food effect studies for
Sivacharan Kollipara, Frederico Severino Martins, Gustavo Mendes Lima Santos   +2 more
exaly   +3 more sources

A physiologically based biopharmaceutics modeling (PBBM) framework for characterizing formulation-dependent food effects: Paving the road towards fed state virtual BE studies for itraconazole amorphous solid dispersions

European Journal of Pharmaceutical Sciences
This study leverages physiologically based biopharmaceutics modeling (PBBM) to predict the clinical performance of two itraconazole (ITRA) amorphous solid dispersions (ASDs), Sempera® and Tolsura®, under fasted and fed state conditions, exploring the potential of PBBM in predicting formulation-specific food interactions.
Niklas, Rudolph, Nitin, Charbe, David, Plano, Abdullah Al, Shoyaib, Arindom, Pal, Heather, Boyce, Liang, Zhao, Fang, Wu, James, Polli, Jennifer, Dressman, Rodrigo, Cristofoletti   +10 more
exaly   +3 more sources

Physiologically Based Biopharmaceutics Modeling (PBBM)

2021
Manuel Ibarra, Alejandra Schiavo, Lawrence J. Lesko   +2 more
openaire   +1 more source

Application of Physiologically Based Biopharmaceutics Modeling (PBBM) to Establish Clinically Relevant Dissolution Specifications for a Prolonged Release Tablet Formulation of Verapamil, a BCS Class I Drug

AAPS PharmSciTech
Our work aimed at setting clinically relevant dissolution specifications for a prolonged release formulation of verapamil, a BCS Class I drug. We have used a two-pronged approach- a Level A IVIVC correlation supplemented with virtual bioequivalence assessment using Physiologically based biopharmaceutics modelling (PBBM).
Anagha Damre, Aniruddha Banerjee
openaire   +2 more sources

The Case for Physiologically Based Biopharmaceutics Modelling (PBBM): What do Dissolution Scientists Need to Know?

Dissolution Technologies, 2020
Vivian A. Gray, James C. Mann, Richard Barker, Xavier J. H. Pepin   +3 more
openaire   +1 more source

PBBM modeling: empowering pharmacotherapy strategies for gastric bypass patients

The prevalence of obesity has surged, with gastric bypass surgery emerging as a primary treatment for severe cases.
openaire   +1 more source

Introducing the Molecular Pharmaceutics Special Issue on the 2023 PBBM Workshop for Drug Product Quality

Molecular Pharmaceutics
Claire Mackie, Xavier Pepin, Tycho Heimbach, Christer Tannergren, Sumit Arora, Sandra Suarez-Sharp, Amitava Mitra, Masoud Jamei, James Polli, Greg Rullo   +9 more
openaire   +2 more sources