Assessment of food effects during clinical development

Z Vinarov, J Butler, F Kesisoglou, M Koziolek… - International Journal of …, 2023 - Elsevier
Food-drug interactions frequently hamper oral drug development due to various
physicochemical, physiological and formulation-dependent mechanisms. This has …

[HTML][HTML] Approaches of formulation bridging in support of orally administered drug product development

M Han, J Xu, Y Lin - International Journal of Pharmaceutics, 2022 - Elsevier
As a drug advances through the late stages of clinical development, formulation changes
are common to meet clinical, manufacturing, and/or business needs. Since some formulation …

Effect of Buffer pH and Concentration on the Dissolution Rates of Sodium Indomethacin–Copovidone and Indomethacin–Copovidone Amorphous Solid Dispersions

CW Chiang, S Tang, C Mao, Y Chen - Molecular Pharmaceutics, 2023 - ACS Publications
The incorporation of counterions into amorphous solid dispersions (ASDs) has been proven
to be effective for improving the dissolution rates of ionizable drugs in ASDs. In this work, the …

Development of an extemporaneous preparation formulation using a simple and non-solubilizing matrix for first in human clinical study

CW Chiang, S Tang, JM Boonstra… - International Journal of …, 2024 - Elsevier
Extemporaneous preparation (EP) formulation is an attractive strategy to accelerate the
formulation development of new chemical entities for first entry into human study. In this …

Generality of Enhancing the Dissolution Rates of Free Acid Amorphous Solid Dispersions by the Incorporation of Sodium Hydroxide

HJ Zhang, CW Chiang… - Molecular …, 2024 - ACS Publications
The incorporation of a counterion into an amorphous solid dispersion (ASD) has been
proven to be an attractive strategy to improve the drug dissolution rate. In this work, the …

Digitalizing the TIM-1 Model using Computational Approaches–Part One: TIM-1 Data Explorer

I Sarcevica, B Hens, I Tomaszewska… - Molecular …, 2023 - ACS Publications
The TIM-1 gastrointestinal model is one of the most advanced in vitro systems currently
available for biorelevant dissolution testing. This technology, the initial version of which was …

Conventional vs Mechanistic IVIVC: A Comparative Study in Establishing Dissolution Safe Space for Extended Release Formulations

S Kollipara, T Ahmed, M Chougule, C Guntupalli… - AAPS …, 2024 - Springer
The use of in vitro-in vivo correlation (IVIVC) for extended release oral dosage forms is an
important technique that can avoid potential clinical studies. IVIVC has been a topic of …

Assessing the Impacts of Drug Loading and Polymer Type on Dissolution Behavior and Diffusive Flux of GDC-6893 Amorphous Solid Dispersions

N Shetty, J Hau, S Tang, PC Chiang, J Liu, W Jia… - Journal of …, 2025 - Elsevier
It is desirable but remains challenging to develop high drug load amorphous solid
dispersions (ASDs) without compromising their quality attributes and bio-performance. In …

Evaluating Utilization of Tiny-TIM to Assess the Effect of Food on the Absorptions of Oral Drugs and Its Application on Biopharmaceutical Modeling

J Liu, K Nagapudi, PC Chiang - Journal of Pharmaceutical Sciences, 2024 - Elsevier
Safety and efficacy are the most critical factors for the development of modern medications.
For oral drugs, evaluating drug exposure under various conditions is one of the most …

Integrating Dynamic in vitro Systems and Mechanistic Absorption Modeling: Case Study of Pralsetinib

MJ Dolton, C Bowman, F Ma, S Cheeti… - Journal of …, 2024 - Elsevier
Dynamic in vitro absorption systems and mechanistic absorption modeling via PBPK have
both shown promise in predicting human oral absorption, although these efforts have been …