Search Results - "Peters, Sheila‐Annie"

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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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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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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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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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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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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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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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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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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Evaluation of a Generic Physiologically Based Pharmacokinetic Model for Lineshape Analysis by Peters, Sheila Annie

“…Background and objective: The mechanistic framework of physiologically based pharmacokinetic (PBPK) models makes them uniquely suited to hypothesis testing and…”
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A Retrospective Evaluation of Allometry, Population Pharmacokinetics, and Physiologically‐Based Pharmacokinetics for Pediatric Dosing Using Clearance as a Surrogate by Wu, Qier, Peters, Sheila Annie

“…Physiologically‐based pharmacokinetic models are increasingly applied for pediatric dose selection along with traditional methods such as allometry and…”
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Can Mechanistic Static Models for Drug-Drug Interactions Support Regulatory Filing for Study Waivers and Label Recommendations? by Gomez-Mantilla, Jose David, Huang, Fenglei, Peters, Sheila Annie

“…Background and Objective Mechanistic static and dynamic physiologically based pharmacokinetic models are used in clinical drug development to assess the risk…”
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Utility of preclinical species for uncertainty assessment and correction of prediction of human volume of distribution using the Rodgers-Lukacova model by Sherbetjian, Eva, Peters, Sheila-Annie, Petersson, Carl

“…Prediction of rat, dog, monkey, and human volume of distribution (VD ss ) by Rodgers-Lukacova model was evaluated using a data set of more than 100 compounds…”
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Prediction of active human dose: learnings from 20 years of Merck KGaA experience, illustrated by case studies by Peters, Sheila Annie, Petersson, Carl, Blaukat, Andree, Halle, Joern-Peter, Dolgos, Hugues

“…•A retrospective analysis of active human dose predictions for 15 drugs is reported.•Case studies illustrate the value of adhering to translational best…”
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Identification of Intestinal Loss of a Drug through Physiologically Based Pharmacokinetic Simulation of Plasma Concentration-Time Profiles by Peters, Sheila Annie

“…Background and objective: Despite recent advances in understanding of the role of the gut as a metabolizing organ, recognition of gut wall metabolism and/or…”
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Hepatic Scaling Factors for In Vitro-In Vivo Extrapolation of Metabolic Drug Clearance in Patients with Colorectal Cancer with Liver Metastasis by Vasilogianni, Areti-Maria, Achour, Brahim, Scotcher, Daniel, Peters, Sheila Annie, Al-Majdoub, Zubida M, Barber, Jill, Rostami-Hodjegan, Amin

“…In vitro-in vivo extrapolation (IVIVE) linked with physiologically based pharmacokinetics (PBPK) modeling is used to predict the fates of drugs in patients…”
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Quantitative Proteomics of Hepatic Drug‐Metabolizing Enzymes and Transporters in Patients With Colorectal Cancer Metastasis by Vasilogianni, Areti‐Maria, Al‐Majdoub, Zubida M., Achour, Brahim, Annie Peters, Sheila, Barber, Jill, Rostami‐Hodjegan, Amin

“…The impact of liver cancer metastasis on protein abundance of 22 drug‐metabolizing enzymes (DMEs) and 25 transporters was investigated using liquid…”
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