Full Text Journal Articles by
Author Sheila Annie Peters

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Prediction of active human dose: learnings from 20 years of Merck KGaA experience, illustrated by case studies.

Sheila Annie Peters, Carl Petersson, Andree Blaukat, Joern-Peter Halle, Hugues Dolgos,

High-quality dose predictions based on a good understanding of target engagement is one of the main translational goals in drug development. Here, we systematically evaluate active human dose predictions for 15 Merck KGaA/EMD Serono assets spanning several modalities and therapeutic areas. Using case studies, we illustrate the value of adhering ... Read more >>

Drug Discov. Today (Drug discovery today)
[2020, :]

Cited: 0 times

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Evaluating the Role of Solubility in Oral Absorption of Poorly Water-Soluble Drugs Using Physiologically-Based Pharmacokinetic Modeling.

Christina Fink, Dajun Sun, Knut Wagner, Melanie Schneider, Holger Bauer, Hugues Dolgos, Karsten M├Ąder, Sheila-Annie Peters,

Poor aqueous solubility and dissolution of drug candidates drive key decisions on lead series optimization during drug discovery, on formulation optimization, and clinical studies planning during drug development. The interpretation of the in vivo relevance of early pharmaceutical profiling is often confounded by the multiple factors affecting oral systemic exposure. ... Read more >>

Clin. Pharmacol. Ther. (Clinical pharmacology and therapeutics)
[2020, 107(3):650-661]

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A Retrospective Evaluation of Allometry, Population Pharmacokinetics, and Physiologically-Based Pharmacokinetics for Pediatric Dosing Using Clearance as a Surrogate.

Qier Wu, Sheila Annie Peters,

Physiologically-based pharmacokinetic models are increasingly applied for pediatric dose selection along with traditional methods such as allometry and population pharmacokinetic models. We report a retrospective evaluation of the three methods. Pediatric population pharmacokinetic models sourced from literature for a subset of eight compounds were used to predict clearances for children ... Read more >>

CPT Pharmacometrics Syst Pharmacol (CPT: pharmacometrics & systems pharmacology)
[2019, 8(4):220-229]

Cited: 1 time

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A comparative evaluation of models to predict human intestinal metabolism from nonclinical data.

Estelle Yau, Carl Petersson, Hugues Dolgos, Sheila Annie Peters,

Extensive gut metabolism is often associated with the risk of low and variable bioavailability. The prediction of the fraction of drug escaping gut wall metabolism as well as transporter-mediated secretion (Fg ) has been challenged by the lack of appropriate preclinical models. The purpose of this study is to compare ... Read more >>

Biopharm Drug Dispos (Biopharmaceutics & drug disposition)
[2017, 38(3):163-186]

Cited: 3 times

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Predicting Drug Extraction in the Human Gut Wall: Assessing Contributions from Drug Metabolizing Enzymes and Transporter Proteins using Preclinical Models.

Sheila Annie Peters, Christopher R Jones, Anna-Lena Ungell, Oliver J D Hatley,

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 quantify it in drug discovery and early development. In recent years, a plethora of models-in vivo, in situ and in vitro-have been discussed in the ... Read more >>

Clin Pharmacokinet (Clinical pharmacokinetics)
[2016, 55(6):673-696]

Cited: 17 times

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Utility of in vitro systems and preclinical data for the prediction of human intestinal first-pass metabolism during drug discovery and preclinical development.

Fredrik H Karlsson, Salim Bouchene, Constanze Hilgendorf, Hugues Dolgos, Sheila Annie Peters,

A growing awareness of the risks associated with extensive intestinal metabolism has triggered an interest in developing robust methods for its quantitative assessment. This study explored the utility of intestinal S9 fractions, human liver microsomes, and recombinant cytochromes P450 to quantify CYP3A-mediated intestinal extraction in humans for a selection of ... Read more >>

Drug Metab. Dispos. (Drug metabolism and disposition: the biological fate of chemicals)
[2013, 41(12):2033-2046]

Cited: 16 times

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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.

Sheila Annie Peters, Patricia E Schroeder, Nagdeep Giri, Hugues Dolgos,

Simcyp, a population-based simulator, is widely used for evaluating drug-drug interaction (DDI) risks in healthy and disease populations. We compare the prediction performance of Simcyp with that of mechanistic static models using different types of inhibitor concentrations, with the aim of understanding their strengths/weaknesses and recommending the optimal use of ... Read more >>

Drug Metab. Dispos. (Drug metabolism and disposition: the biological fate of chemicals)
[2012, 40(8):1495-1507]

Cited: 15 times

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Physiologically based pharmacokinetic (PBPK) modeling and simulation: applications in lead optimization.

Sheila Annie Peters, Anna-Lena Ungell, Hugues Dolgos,

Physiologically based pharmacokinetics (PBPK) models are increasingly being used in the lead optimization (LO) process. Although there are currently few literature reports of the application of PBPK, the scope of PBPK modeling is expanding and there is a steady increase in the number of publications in this field. Recent publications ... Read more >>

Curr Opin Drug Discov Devel (Current opinion in drug discovery & development)
[2009, 12(4):509-518]

Cited: 8 times

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Evaluation of a generic physiologically based pharmacokinetic model for lineshape analysis.

Sheila Annie Peters,

The mechanistic framework of physiologically based pharmacokinetic (PBPK) models makes them uniquely suited to hypothesis testing and lineshape analysis, which help provide valuable insights into mechanisms that contribute to the observed concentration-time profiles. The aim of this article is to evaluate the utility of PBPK models for simulating oral lineshapes ... Read more >>

Clin Pharmacokinet (Clinical pharmacokinetics)
[2008, 47(4):261-275]

Cited: 41 times

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Identification of intestinal loss of a drug through physiologically based pharmacokinetic simulation of plasma concentration-time profiles.

Sheila Annie Peters,

Despite recent advances in understanding of the role of the gut as a metabolizing organ, recognition of gut wall metabolism and/or other factors contributing to intestinal loss of a compound has been a challenging task due to the lack of well characterized methods to distinguish it from first-pass hepatic extraction. ... Read more >>

Clin Pharmacokinet (Clinical pharmacokinetics)
[2008, 47(4):245-259]

Cited: 20 times

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Early identification of drug-induced impairment of gastric emptying through physiologically based pharmacokinetic (PBPK) simulation of plasma concentration-time profiles in rat.

Sheila Annie Peters, Leif Hultin,

Inhibition of gastric emptying rate can have adverse effects on the absorption of food and nutrients. The absorption phase of the plasma concentration-time profile of a compound administered orally to pre-clinical species reflects among others, the gastric and intestinal transit kinetics, and can thus assist in the early identification of ... Read more >>

J Pharmacokinet Pharmacodyn (Journal of pharmacokinetics and pharmacodynamics)
[2008, 35(1):1-30]

Cited: 17 times

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