Search Results - "Peters, Sheila"

Evaluating the Role of Solubility in Oral Absorption of Poorly Water‐Soluble Drugs Using Physiologically‐Based Pharmacokinetic Modeling by Fink, Christina, Sun, Dajun, Wagner, Knut, Schneider, Melanie, Bauer, Holger, Dolgos, Hugues, Mäder, Karsten, Peters, Sheila‐Annie

“…Poor aqueous solubility and dissolution of drug candidates drive key decisions on lead series optimization during drug discovery, on formulation optimization,…”
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Identification of solubility-limited absorption of oral anticancer drugs using PBPK modeling based on rat PK and its relevance to human by Fink, Christina, Lecomte, Marc, Badolo, Lassina, Wagner, Knut, Mäder, Karsten, Peters, Sheila-Annie

“…•A PBPK analysis of rat pharmacokinetic data was utilized to identify drugs whose absorption are truly limited by solubility in the rat.•The proposed PBPK…”
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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 by Macwan, Joyce S., Fraczkiewicz, Grace, Bertolino, Mauro, Krüger, Phillip, Peters, Sheila‐Annie

“…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…”
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The Efficacy of Continuous Passive Motion After Total Knee Arthroplasty: A Comparison of Three Protocols by Boese, C. Kent, MD, Weis, Marcia, RN, MSN, ONC, Phillips, Tamra, MSPT, DPT, Lawton-Peters, Sheila, MSN, APRN, CCRN, CNS NP-BC, Gallo, Theresa, PA-C, MPA, Centeno, Leslie, BA

“…Abstract We conducted a randomized, controlled trial to determine the efficacy of CPM following total knee arthroplasty (TKA). Postoperative outcomes of…”
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Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective by Shebley, Mohamad, Sandhu, Punam, Emami Riedmaier, Arian, Jamei, Masoud, Narayanan, Rangaraj, Patel, Aarti, Peters, Sheila Annie, Reddy, Venkatesh Pilla, Zheng, Ming, Zwart, Loeckie, Beneton, Maud, Bouzom, Francois, Chen, Jun, Chen, Yuan, Cleary, Yumi, Collins, Christiane, Dickinson, Gemma L., Djebli, Nassim, Einolf, Heidi J., Gardner, Iain, Huth, Felix, Kazmi, Faraz, Khalil, Feras, Lin, Jing, Odinecs, Aleksandrs, Patel, Chirag, Rong, Haojing, Schuck, Edgar, Sharma, Pradeep, Wu, Shu‐Pei, Xu, Yang, Yamazaki, Shinji, Yoshida, Kenta, Rowland, Malcolm

“…This work provides a perspective on the qualification and verification of physiologically based pharmacokinetic (PBPK) platforms/models intended for regulatory…”
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Model-based drug discovery: implementation and impact by Visser, Sandra A.G., Aurell, Malin, Jones, Rhys D.O., Schuck, Virna J.A., Egnell, Ann-Charlotte, Peters, Sheila A., Brynne, Lena, Yates, James W.T., Jansson-Löfmark, Rasmus, Tan, Beesan, Cooke, Marie, Barry, Simon T., Hughes, Andrew, Bredberg, Ulf

“…•Implementation of quantitative pharmacology strategy to discovery drug projects.•Building dedicated preclinical M&S capability.•Developing a companywide…”
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Physiologically‐Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective by Heimbach, Tycho, Chen, Yuan, Chen, Jun, Dixit, Vaishali, Parrott, Neil, Peters, Sheila Annie, Poggesi, Italo, Sharma, Pradeep, Snoeys, Jan, Shebley, Mohamad, Tai, Guoying, Tse, Susanna, Upreti, Vijay V., Wang, Ying‐Hong, Tsai, Alice, Xia, Binfeng, Zheng, Ming, Zhu, Andy Z.X., Hall, Stephen

“…The predictive performance of physiologically‐based pharmacokinetics (PBPK) models for pharmacokinetics (PK) in renal impairment (RI) and hepatic impairment…”
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Predicting Drug Extraction in the Human Gut Wall: Assessing Contributions from Drug Metabolizing Enzymes and Transporter Proteins using Preclinical Models by Peters, Sheila Annie, Jones, Christopher R., Ungell, Anna-Lena, Hatley, Oliver J. D.

“…Intestinal metabolism can limit oral bioavailability of drugs and increase the risk of drug interactions. It is therefore important to be able to predict and…”
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Single Nucleotide Polymorphisms, Apoptosis, and the Development of Severe Late Adverse Effects After Radiotherapy by AZRIA, David, OZSAHIN, Mahmut, ROSENSTEIN, Barry S, KRAMAR, Andrew, PETERS, Sheila, ATENCIO, David P, CROMPTON, Nigel E. A, MORNEX, Francoise, PELEGRIN, André, DUBOIS, Jean-Bernard, MIRIMANOFF, René-Olivier

“…Purpose: Evidence has accumulated in recent years suggestive of a genetic basis for a susceptibility to the development of radiation injury after cancer…”
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TGFB1 Single Nucleotide Polymorphisms Are Associated With Adverse Quality of Life in Prostate Cancer Patients Treated With Radiotherapy by Peters, Christopher A., M.D, Stock, Richard G., M.D, Cesaretti, Jamie A., M.D, Atencio, David P., Ph.D, Peters, Sheila, B.A, Burri, Ryan J., M.D, Stone, Nelson N., M.D, Ostrer, Harry, M.D, Rosenstein, Barry S., Ph.D

“…Purpose To investigate whether the presence of single nucleotide polymorphisms (SNPs) located within TGFB1 might be predictive for the development of adverse…”
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Genetic predictors of adverse radiotherapy effects: the Gene-PARE project by Ho, Alice Y, Atencio, David P, Peters, Sheila, Stock, Richard G, Formenti, Silvia C, Cesaretti, Jamie A, Green, Sheryl, Haffty, Bruce, Drumea, Karen, Leitzin, Larisa, Kuten, Abraham, Azria, David, Ozsahin, Mahmut, Overgaard, Jens, Andreassen, Christian N, Trop, Cynthia S, Park, Janelle, Rosenstein, Barry S

“…The development of adverse effects resulting from the radiotherapy of cancer limits the use of this treatment modality. The validation of a test capable of…”
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Proteomic quantification of receptor tyrosine kinases involved in the development and progression of colorectal cancer liver metastasis by Vasilogianni, Areti-Maria, Al-Majdoub, Zubida M, Achour, Brahim, Peters, Sheila Annie, Rostami-Hodjegan, Amin, Barber, Jill

“…Alterations in expression and activity of human receptor tyrosine kinases (RTKs) are associated with cancer progression and in response to therapeutic…”
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Gut Wall Metabolism. Application of Pre-Clinical Models for the Prediction of Human Drug Absorption and First-Pass Elimination by Jones, Christopher R., Hatley, Oliver J. D., Ungell, Anna-Lena, Hilgendorf, Constanze, Peters, Sheila Annie, Rostami-Hodjegan, Amin

“…Quantifying the multiple processes which control and modulate the extent of oral bioavailability for drug candidates is critical to accurate projection of…”
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A comparative evaluation of models to predict human intestinal metabolism from nonclinical data by Yau, Estelle, Petersson, Carl, Dolgos, Hugues, Peters, Sheila Annie

“…Extensive gut metabolism is often associated with the risk of low and variable bioavailability. The prediction of the fraction of drug escaping gut wall…”
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A Genetically Determined Dose–Volume Histogram Predicts for Rectal Bleeding among Patients Treated With Prostate Brachytherapy by Cesaretti, Jamie A., M.D., M.S, Stock, Richard G., M.D, Atencio, David P., Ph.D, Peters, Sheila A., B.A, Peters, Christopher A., M.D, Burri, Ryan J., M.D, Stone, Nelson N., M.D, Rosenstein, Barry S., Ph.D

“…Purpose: To examine whether possession of genetic alterations in the ATM (ataxia telangiectasia) gene is associated with rectal bleeding in a dose-dependent…”
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Evaluation of the use of static and dynamic models to predict drug-drug interaction and its associated variability: impact on drug discovery and early development by Peters, Sheila Annie, Schroeder, Patricia E, Giri, Nagdeep, Dolgos, Hugues

“…Simcyp, a population-based simulator, is widely used for evaluating drug-drug interaction (DDI) risks in healthy and disease populations. We compare the…”
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Requirements to Establishing Confidence in Physiologically Based Pharmacokinetic (PBPK) Models and Overcoming Some of the Challenges to Meeting Them by Peters, Sheila Annie, Dolgos, Hugues

“…When scientifically well-founded, the mechanistic basis of physiologically based pharmacokinetic (PBPK) models can help reduce the uncertainty and increase…”
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Recommendations for the Design of Clinical Drug–Drug Interaction Studies With Itraconazole Using a Mechanistic Physiologically‐Based Pharmacokinetic Model by Chen, Yuan, Cabalu, Tamara D., Callegari, Ernesto, Einolf, Heidi, Liu, Lichuan, Parrott, Neil, Peters, Sheila Annie, Schuck, Edgar, Sharma, Pradeep, Tracey, Helen, Upreti, Vijay V., Zheng, Ming, Zhu, Andy Z.X., Hall, Stephen D.

“…Regulatory agencies currently recommend itraconazole (ITZ) as a strong cytochrome P450 3A (CYP3A) inhibitor for clinical drug–drug interaction (DDI) studies…”
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Cellular Response to DNA Damage by KAO, JOHNNY, ROSENSTEIN, BARRY S., PETERS, SHEILA, MILANO, MICHAEL T., KRON, STEPHEN J.

“…: Eukaryotic cells, from yeast to man, possess evolutionarily conserved mechanisms to accurately and efficiently repair the overwhelming majority of DNA…”
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Impact of input parameters on the prediction of hepatic plasma clearance using the well-stirred model by Wan, Hong, Bold, Peter, Larsson, Lars-Olof, Ulander, Johan, Peters, Sheila, Löfberg, Boel, Ungell, Anna-Lena, Någård, Mats, Llinàs, Antonio

“…The in vitro metabolic stability assays are indispensable for screening the metabolic liability of new chemical entities (NCEs) in drug discovery. Intrinsic…”
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