Results 21 to 30 of about 23,818,397 (163)

Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report. [PDF]

Mol Pharm
Mackie C, Arora S, Seo P, Moody R, Rege B, Pepin X, Heimbach T, Tannergren C, Mitra A, Suarez-Sharp S, Borges LN, Kijima S, Kotzagiorgis E, Malamatari M, Veerasingham S, Polli JE, Rullo G.   +16 more
europepmc   +2 more sources

In-Depth Analysis of Physiologically Based Pharmacokinetic (PBPK) Modeling Utilization in Different Application Fields Using Text Mining Tools

Pharmaceutics, 2022
In the past decade, only a small number of papers have elaborated on the application of physiologically based pharmacokinetic (PBPK) modeling across different areas. In this review, an in-depth analysis of the distribution of PBPK modeling in relation to
Aleksandra Krstevska, Jelena Đuriš, Svetlana Ibrić, Sandra Cvijić   +3 more
doaj   +1 more source

A text mining study on the utility of physiologically based pharmacokinetic/biopharmaceutics modeling (PBPK/PBBM) in formulation development [PDF]

, 2023
Physiologically based pharmacokinetic (PBPK) modeling is an evolving tool that has a profound impact on drug discovery and formulation development processes.
Aleksandra Krstevska, Jelena Đjurić, Krstevska, Aleksandra, Svetlana Ibric, Sandra Cvijić, Ibrić, Svetlana, Cvijić, Sandra, Đuriš, Jelena   +7 more
core   +1 more source

Understanding effect site pharmacology of uprifosbuvir, a hepatitis C virus nucleoside inhibitor: Case study of a multidisciplinary modeling approach in drug development

CPT: Pharmacometrics & Systems Pharmacology, 2021
Uprifosbuvir is a uridine nucleoside monophosphate prodrug inhibitor of the hepatitis C virus NS5B RNA polymerase. To quantitatively elucidate key metabolic pathways, assess the link between unmeasurable effect site concentrations and viral load ...
Paul van den Berg, Wei Gao, Maurice J. Ahsman, Leticia Arrington, Filippos Kesisoglou, Randy Miller, Teun M. Post, Matthew L. Rizk   +7 more
doaj   +1 more source

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality

, 2022
S.594-609This report summarizes the proceedings for Day 3 of the workshop titled ""Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls"".
Suarez-Sharp, S., Ning, B., Zhao, Y., Flanagan, T., Heimbach, T., Lima Santos, G.M., Rullo, G., Zolnik, B., Pepin, X.J.H., Parrott, N., Sjögren, E., Kotzagiorgis, E., Li, M., Mitra, A., Sharan, S., Wu, F., Tistaert, C., Raines, K., Kijima, S., Dressman, J., Dickinson, P.A., Kakar, S., Mandula, H., Babiskin, A., Delvadia, P., Anand, O., Veerasingham, S.   +26 more
core   +1 more source

Comparison of Compartmental and Non-Compartmental Analysis to Detect Biopharmaceutical Similarity of Intravenous Nanomaterial-Based Rifabutin Formulations

Pharmaceutics, 2023
Pharmacometric analysis is often used to quantify the differences and similarities between formulation prototypes. In the regulatory framework, it plays a significant role in the evaluation of bioequivalence.
Nadezhda Osipova, Andrey Budko, Olga Maksimenko, Elena Shipulo, Ludmila Vanchugova, Wenqian Chen, Svetlana Gelperina, Matthias G. Wacker   +7 more
doaj   +1 more source

A physiologically-based nanocarrier biopharmaceutics model to reverse-engineer the in vivo drug release

, 2022
S.257-272Over the years, a wide variety of nanomedicines has entered global markets, providing a blueprint for the emerging generics industry. They are characterized by a unique pharmacokinetic behavior difficult to explain with conventional methods.
Modh, H., Mast, M.-P., Tan, A.X.X., Braner, S., Nagpal, S., Albrecht, V., Wacker, M.G., Chichakly, K.   +7 more
core   +1 more source

Development of Biopredictive Dissolution Method for Extended-Release Desvenlafaxine Tablets

Pharmaceutics, 2023
This study aimed to develop a biopredictive dissolution method for desvenlafaxine ER tablets using design of experiments (DoE) and physiologically based biopharmaceutics modeling (PBBM) to address the challenge of developing generic drug products by ...
Gustavo Vaiano Carapeto, Marcelo Dutra Duque, Michele Georges Issa, Humberto Gomes Ferraz   +3 more
doaj   +1 more source

Food and bile micelle binding of quaternary ammonium compounds

ADMET and DMPK, 2023
Background and Purpose: Physiologically-based biopharmaceutics modeling (PBBM) has been widely used to predict the oral absorption of drugs. However, the prediction of food effects on oral drug absorption is still challenging, especially for negative ...
Sumiji Takeru, Kiyohiko Sugano
doaj   +1 more source

Application of the Gastrointestinal Simulator (GIS) Coupled with In Silico Modeling to Measure the Impact of Coca-Cola^® on the Luminal and Systemic Behavior of Loratadine (BCS Class 2b)

Pharmaceutics, 2020
In the present work, we explored if Coca-Cola® had a beneficial impact on the systemic outcome of the weakly basic drug loratadine (Wal-itin®, immediate-release formulation, 10 mg, generic drug product).
Bart Hens, Marival Bermejo, Patrick Augustijns, Rodrigo Cristofoletti, Gregory E. Amidon, Gordon L. Amidon   +5 more
doaj   +1 more source