[HTML][HTML] Current challenges and future perspectives in oral absorption research: An opinion of the UNGAP network

Z Vinarov, B Abrahamsson, P Artursson… - Advanced Drug Delivery …, 2021 - Elsevier
Although oral drug delivery is the preferred administration route and has been used for
centuries, modern drug discovery and development pipelines challenge conventional …

[HTML][HTML] Clinical trials and clinical research: a comprehensive review

V Kandi, S Vadakedath - Cureus, 2023 - ncbi.nlm.nih.gov
Clinical research is an alternative terminology used to describe medical research. Clinical
research involves people, and it is generally carried out to evaluate the efficacy of a …

Biopharmaceutics applications of physiologically based pharmacokinetic absorption modeling and simulation in regulatory submissions to the US Food and Drug …

F Wu, H Shah, M Li, P Duan, P Zhao, S Suarez… - The AAPS Journal, 2021 - Springer
Physiologically based pharmacokinetic (PBPK) absorption modeling and simulation is
increasingly used as a tool in drug product development, not only in support of clinical …

Ingestible devices for studying the gastrointestinal physiology and their application in oral biopharmaceutics

W Weitschies, L Müller, M Grimm, M Koziolek - Advanced Drug Delivery …, 2021 - Elsevier
Ingestible sensor systems are unique tools for obtaining physiological data from an
undisturbed gastrointestinal tract. Since their dimensions correspond to monolithic oral …

Application of a novel PhysioCell apparatus for biopredictive dissolution tests of oral immediate release formulations–A case study workflow for in vitro-in vivo …

M Romański, M Staniszewska, J Paszkowska… - International Journal of …, 2023 - Elsevier
Biorelevant dissolution tests of oral solid dosage forms open the gate to valid in vitro-in vivo
predictions (IVIVP). A recently developed apparatus, PhysioCell, allows mimicking the fluid …

Adapting physiologically-based pharmacokinetic models for machine learning applications

S Habiballah, B Reisfeld - Scientific Reports, 2023 - nature.com
Both machine learning and physiologically-based pharmacokinetic models are becoming
essential components of the drug development process. Integrating the predictive …

Application of physiologically based absorption and pharmacokinetic modeling in the development process of oral modified release generic products

S Subhani, C Kim, P Muniz, M Rodriguez… - European Journal of …, 2022 - Elsevier
Physiologically based pharmacokinetic (PBPK) modeling for biopharmaceutics applications
holds great promise as modelling and simulation tool in the field of modern oral modified …

Development and bio-predictive evaluation of biopharmaceutical properties of sustained-release tablets with a novel GPR40 agonist for a first-in-human clinical trial

E Juszczyk, K Kisło, P Żero, E Tratkiewicz, M Wieczorek… - Pharmaceutics, 2021 - mdpi.com
Sustained-release (SR) formulations may appear advantageous in first-in-human (FIH) study
of innovative medicines. The newly developed SR matrix tablets require prolonged …

Dissolution

H Batchelor, J Butler - Biopharmaceutics: From Fundamentals …, 2022 - Wiley Online Library
This chapter aims to demonstrate the value of dissolution within biopharmaceutics and to
highlight the types of apparatus used to better understand the mechanisms associated with …

ORBIS project–where have we arrived?

M Skotnicki, E Jakubowska, W Smułek… - Journal of Medical …, 2023 - jms.ump.edu.pl
Abstract The Open Research Biopharmaceutical Internships Support project (ORBIS) was a
response to the scientific, economic, and social challenge of increasing the effectiveness …