In vitro to in vivo extrapolation for high throughput prioritization and decision making

SM Bell, X Chang, JF Wambaugh, DG Allen, M Bartels… - Toxicology in vitro, 2018 - Elsevier
In vitro chemical safety testing methods offer the potential for efficient and economical tools
to provide relevant assessments of human health risk. To realize this potential, methods are …

IVIVE: Facilitating the Use of In Vitro Toxicity Data in Risk Assessment and Decision Making

X Chang, YM Tan, DG Allen, S Bell, PC Brown… - Toxics, 2022 - mdpi.com
During the past few decades, the science of toxicology has been undergoing a
transformation from observational to predictive science. New approach methodologies …

Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review

P Zhao, L Zhang, JA Grillo, Q Liu… - Clinical …, 2011 - Wiley Online Library
Physiologically based pharmacokinetic (PBPK) modeling and simulation is a tool that can
help predict the pharmacokinetics of drugs in humans and evaluate the effects of intrinsic …

Assessing the performance of amorphous solid dispersions

A Newman, G Knipp, G Zografi - Journal of pharmaceutical sciences, 2012 - Elsevier
The characterization and performance of stable amorphous solid dispersion systems were
evaluated in 40 research papers reporting active pharmaceutical ingredient (API) dissolution …

PBPK models for the prediction of in vivo performance of oral dosage forms

ES Kostewicz, L Aarons, M Bergstrand… - European Journal of …, 2014 - Elsevier
Drug absorption from the gastrointestinal (GI) tract is a highly complex process dependent
upon numerous factors including the physicochemical properties of the drug, characteristics …

Physiologically-based pharmacokinetics in drug development and regulatory science

M Rowland, C Peck, G Tucker - Annual review of pharmacology …, 2011 - annualreviews.org
The application of physiologically-based pharmacokinetic (PBPK) modeling is coming of
age in drug development and regulation, reflecting significant advances over the past 10 …

Evaluating In Vitro-In Vivo Extrapolation of Toxicokinetics

JF Wambaugh, MF Hughes, CL Ring… - Toxicological …, 2018 - academic.oup.com
Prioritizing the risk posed by thousands of chemicals potentially present in the environment
requires exposure, toxicity, and toxicokinetic (TK) data, which are often unavailable …

Use of physiologically based pharmacokinetic (PBPK) modeling for predicting drug-food interactions: an industry perspective

AE Riedmaier, K DeMent, J Huckle, P Bransford… - The AAPS journal, 2020 - Springer
The effect of food on pharmacokinetic properties of drugs is a commonly observed
occurrence affecting about 40% of orally administered drugs. Within the pharmaceutical …

Oral controlled and sustained drug delivery systems: Concepts, advances, preclinical, and clinical status

G Kaur, J Grewal, K Jyoti, UK Jain, R Chandra… - Drug targeting and …, 2018 - Elsevier
Owing to the difficulty in developing new drug moieties, greater emphasis is being given to
developing new drug delivery systems for existing drugs. The oral route is the major …

High-throughput PBTK models for in vitro to in vivo extrapolation

M Breen, CL Ring, A Kreutz, MR Goldsmith… - Expert opinion on …, 2021 - Taylor & Francis
Introduction Toxicity data are unavailable for many thousands of chemicals in commerce
and the environment. Therefore, risk assessors need to rapidly screen these chemicals for …