Results 31 to 40 of about 278 (111)

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   +1 more source

Subcutaneous Biopharmaceutics: Building tools for a flexible future

British Journal of Pharmacy, 2023
The major biopharmaceutics challenge faced during the development of subcutaneous (SC) drug products is the limited understanding of the physiological factors and the combination product attributes that can impact absorption rate/extent and drug product ...
Kate Louise Harris , J Matthew Wood , Laura Garcia Gonzalez, Simon Todd, Iain Grant   +4 more
doaj   +1 more source

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   +1 more source

Harnessing Open-Source Solutions: Insights From the First Open Systems Pharmacology (OSP) Community Conference. [PDF]

CPT Pharmacometrics Syst Pharmacol
ABSTRACT In 2017, the free and open‐source software Open Systems Pharmacology (OSP) was launched. Since then, OSP has evolved from a small community into a diverse network of stakeholders committed to advancing open‐source solutions for model‐informed drug development (MIDD). In this context, the first OSP Community Conference was hosted by Novartis in
Dallmann A, Feick D, Balazki P, Benamara S, Burghaus R, Chenel M, Choi SL, Cordes H, Guimarães M, Hamadeh A, Ince I, Job KM, Kanacher T, Kovar A, Kuepfer L, Lippert J, Macente J, Nauwelaerts N, Niederalt C, Peters S, Proença S, Sato M, Schaller S, Schlender JF, Schneider A, Sjögren E, Solodenko J, Staab A, Vrenken P, Wendl T, de Witte WEA, Teutonico D.   +31 more
europepmc   +2 more sources

Application of physiologically based biopharmaceutics modeling to understand the impact of dissolution differences on in vivo performance of immediate release products: The case of bisoprolol

CPT: Pharmacometrics & Systems Pharmacology, 2021
Merck KGaA observed slight differences in the dissolution of Concor® (bisoprolol) batches over the years. The purpose of this work was to assess the impact of in vitro dissolution on the simulated pharmacokinetics of bisoprolol using in vitro–in vivo ...
Joyce S. Macwan, Grace Fraczkiewicz, Mauro Bertolino, Phillip Krüger, Sheila‐Annie Peters   +4 more
doaj   +1 more source

Development of Biopredictive Dissolution Method for Extended-Release Desvenlafaxine Tablets

Pharmaceutics, 2023
This study aimed to develop a biopredictive dissolution method for desvenlafaxine ER tablets using design of experiments (DoE) and physiologically based biopharmaceutics modeling (PBBM) to address the challenge of developing generic drug products by ...
Gustavo Vaiano Carapeto, Marcelo Dutra Duque, Michele Georges Issa, Humberto Gomes Ferraz   +3 more
doaj   +1 more source

Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

CPT: Pharmacometrics &Systems Pharmacology, Volume 12, Issue 5, Page 585-597, May 2023., 2023
Abstract This report summarizes the proceedings for day 2 sessions 1 and 3 of the 2‐day public workshop entitled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches,” a jointly sponsored workshop by the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG). The aims of this
Fang Wu, Youssef Mousa, Kimberly Raines, Chris Bode, Yu Chung Tsang, Rodrigo Cristofoletti, Hongling Zhang, Tycho Heimbach, Lanyan Fang, Filippos Kesisoglou, Amitava Mitra, James Polli, Myong‐Jin Kim, Jianghong Fan, Banu S. Zolnik, Duxin Sun, Yi Zhang, Liang Zhao   +17 more
wiley   +1 more source

Peripheral lymphocytes and lactate dehydrogenase correlate with response and survival in head and neck cancers treated with immune checkpoint inhibitors

Cancer Medicine, Volume 12, Issue 8, Page 9384-9391, April 2023., 2023
Abstract Background Little is known regarding associations between peripheral blood biomarkers (PBBMs) and survival, response, and toxicity in recurrent/metastatic head and neck squamous cell carcinomas (R/M HNSCC) treated with immune checkpoint inhibitors (ICIs). Methods In this single‐institution retrospective cohort study, a dataset of patients with
Cassie Pan, Qian Vicky Wu, Jenna Voutsinas, Jeffrey J. Houlton, Brittany Barber, Zain H. Rizvi, Emily Marchiano, Neal Futran, George E. Laramore, Jay J. Liao, Upendra Parvathaneni, Renato G. Martins, Jonathan R. Fromm, Cristina P. Rodriguez   +13 more
wiley   +1 more source

A text mining study on the utility of physiologically based pharmacokinetic/biopharmaceutics modeling (PBPK/PBBM) in formulation development

Macedonian Pharmaceutical Bulletin, 2023
14th Central European Symposium on Pharmaceutical Technology, 28th - 30th September, Ohrid, N.
Krstevska, Aleksandra, Đuriš, Jelena, Ibrić, Svetlana, Cvijić, Sandra   +3 more
openaire   +2 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   +1 more source