Results 41 to 50 of about 455 (133)

Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling. [PDF]

CPT Pharmacometrics Syst Pharmacol
ABSTRACT Physiologically based pharmacokinetic (PBPK) modeling is a mechanistic cornerstone of model‐informed drug development (MIDD), providing evidence for regulatory decisions. PBPK models integrate physiological and pharmacological data and have been applied across a plethora of contexts of use, including assessing drug–drug interactions (DDIs ...
Chenel M, Dallmann A, Ince I, Meyer M, Schlender JF, Teutonico D, Sjögren E.   +6 more
europepmc   +2 more sources

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

Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report. [PDF]

Mol Pharm
36973731This Article shares the proceedings from the August 29th, 2023 (day 1) workshop “Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives”.
Pepin X, Arora S, Borges L, Cano-Vega M, Carducci T, Chatterjee P, Chen G, Cristofoletti R, Dallmann A, Delvadia P, Dressman J, Fotaki N, Gray E, Heimbach T, Holte Ø, Kijima S, Kotzagiorgis E, Lennernäs H, Lindahl A, Loebenberg R, Mackie C, Malamatari M, McAllister M, Mitra A, Moody R, Mudie D, Musuamba Tshinanu F, Polli JE, Rege B, Ren X, Rullo G, Scherholz M, Song I, Stillhart C, Suarez-Sharp S, Tannergren C, Tsakalozou E, Veerasingham S, Wagner C, Seo P.   +39 more
europepmc   +4 more sources

Proteomic blood-based biomarkers of brain damage in traumatic brain injury: are they suitable surrogate endpoints for cerebral pressure autoregulatory-guided therapy? [PDF]

Crit Care
Background: Management after severe traumatic brain injury (TBI) aims to prevent secondary injury by optimizing cerebral physiology, yet conventional metrics such as intracranial pressure (ICP) and cerebral perfusion pressure (CPP) incompletely capture ...
Kevci R, Hånell A, Aries M, Åkerlund C, Buki A, Bhattacharyay S, Di Tommaso G, Hendrix R, Newcombe V, Lewén A, Enblad P, Beqiri E, Smielewski P, Wettervik TS, HR subgroup CENTER-TBI collaborators.   +14 more
europepmc   +2 more sources

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

Development of Extended-Release Mini-Tablets Containing Metoprolol Supported by Design of Experiments and Physiologically Based Biopharmaceutics Modeling

Pharmaceutics, 2022
The development of extended-release dosage forms with adequate drug release is a challenge for pharmaceutical companies, mainly when the drug presents high solubility, as in Biopharmaceutics Classification System (BCS) class I.
Michele Georges Issa, Natalia Vieira de Souza, Bruna Wenyi Chuang Jou, Marcelo Dutra Duque, Humberto Gomes Ferraz   +4 more
doaj   +1 more source

Physiologically based pharmacokinetic modeling and simulations to inform dissolution specifications and clinical relevance of release rates on elagolix exposure

Biopharmaceutics &Drug Disposition, Volume 43, Issue 3, Page 98-107, June 2022., 2022
This analysis used a physiologically based pharmacokinetic model to predict the impact of changes in dissolution rates on elagolix exposures and define clinically relevant acceptance criteria for dissolution. The simulation results indicated that a slower in vitro dissolution profile would not have clinically significant impact on elagolix exposures ...
Dwaipayan Mukherjee, Manoj S. Chiney, Xi Shao, Tzuchi R. Ju, Mohamad Shebley, Patrick Marroum   +5 more
wiley   +1 more source