Results 131 to 140 of about 773 (143)

Prediction of fasted and fed bioequivalence for immediate release drug products using physiologically based biopharmaceutics modeling (PBBM)

European Journal of Pharmaceutical Sciences, 2020
Bioequivalence studies are an integral part of clinical pharmacology strategy for drug development. Physiologically based biopharmaceutics modeling (PBBM) can be a helpful tool to assess potential bioequivalence risks and predict the outcome of bioequivalence studies.
Jereb Rebeka
exaly   +3 more sources

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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
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An Enabling Formulation of a Weakly Basic Compound Guided by Physiologically Based Biopharmaceutics Modeling (PBBM)

Journal of Pharmaceutical Sciences, 2022
Weakly basic compounds propose biopharmaceutics risks due to the possibility of precipitation out of solution when passing from the stomach to the intestine. This behavior would limit the available drug for absorption and in turn reduces the plasma exposure at dose escalation scenarios in phase 1 clinical trials.
openaire   +2 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, Tausif Ahmed, Maitri Sanghavi   +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.
Rodrigo Cristofoletti
exaly   +3 more sources

Development of a novel physiologically based biopharmaceutics modeling (PBBM) framework using the open systems pharmacology suite, part 1: in vitro modeling of vericiguat

European Journal of Pharmaceutical Sciences
Maria Vertzoni, André Dallmann
exaly   +2 more sources

Physiologically Based Biopharmaceutics Modeling (PBBM)

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

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. Predavanje po pozivu (M32)
openaire   +1 more source