Drug nanocrystals in the commercial pharmaceutical development process

JP Möschwitzer - International journal of pharmaceutics, 2013 - Elsevier
Nanosizing is one of the most important drug delivery platform approaches for the
commercial development of poorly soluble drug molecules. The research efforts of many …

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 …

Applied concepts in PBPK modeling: how to build a PBPK/PD model

L Kuepfer, C Niederalt, T Wendl… - CPT …, 2016 - Wiley Online Library
The aim of this tutorial is to introduce the fundamental concepts of physiologically based
pharmacokinetic/pharmacodynamic (PBPK/PD) modeling with a special focus on their …

The Biopharmaceutics Classification System: subclasses for in vivo predictive dissolution (IPD) methodology and IVIVC

Y Tsume, DM Mudie, P Langguth, GE Amidon… - European Journal of …, 2014 - Elsevier
Abstract The Biopharmaceutics Classification System (BCS) has found widespread utility in
drug discovery, product development and drug product regulatory sciences. The …

Applications of PBPK/PBBM modeling in generic product development: an industry perspective

K Yuvaneshwari, S Kollipara, T Ahmed… - Journal of Drug Delivery …, 2022 - Elsevier
Physiologically based pharmacokinetic (PBPK) modeling and physiologically based
biopharmaceutics modeling (PBBM) are invaluable tools with wide applications during drug …

Integrating cellular metabolism into a multiscale whole-body model

M Krauss, S Schaller, S Borchers… - PLoS computational …, 2012 - journals.plos.org
Cellular metabolism continuously processes an enormous range of external compounds into
endogenous metabolites and is as such a key element in human physiology. The …

Optimizing nanomedicine pharmacokinetics using physiologically based pharmacokinetics modelling

DM Moss, M Siccardi - British journal of pharmacology, 2014 - Wiley Online Library
The delivery of therapeutic agents is characterized by numerous challenges including poor
absorption, low penetration in target tissues and non‐specific dissemination in organs …

Utility of physiologically based absorption modeling in implementing quality by design in drug development

X Zhang, RA Lionberger, BM Davit, LX Yu - The AAPS journal, 2011 - Springer
Abstract To implement Quality by Design (QbD) in drug development, scientists need tools
that link drug products properties to in vivo performance. Physiologically based absorption …

IMI–Oral biopharmaceutics tools project–Evaluation of bottom-up PBPK prediction success part 2: An introduction to the simulation exercise and overview of results

A Margolskee, AS Darwich, X Pepin, L Aarons… - European Journal of …, 2017 - Elsevier
Orally administered drugs are subject to a number of barriers impacting bioavailability (F
oral), causing challenges during drug and formulation development. Physiologically-based …

On absorption modeling and food effect prediction of rivaroxaban, a BCS II drug orally administered as an immediate-release tablet

V Kushwah, S Arora, M Tamás Katona, D Modhave… - Pharmaceutics, 2021 - mdpi.com
The present work evaluates the food effect on the absorption of rivaroxaban (Riva), a BCS II
drug, from the orally administered commercial immediate-release tablet (Xarelto IR) using …