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 …
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 …
transformation from observational to predictive science. New approach methodologies …
Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review
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 …
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 …
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 …
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 …
age in drug development and regulation, reflecting significant advances over the past 10 …
Evaluating In Vitro-In Vivo Extrapolation of Toxicokinetics
Prioritizing the risk posed by thousands of chemicals potentially present in the environment
requires exposure, toxicity, and toxicokinetic (TK) data, which are often unavailable …
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 …
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 …
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
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 …
and the environment. Therefore, risk assessors need to rapidly screen these chemicals for …