Results 71 to 80 of about 690 (120)

Development of a Universal In Vivo Predictive Dissolution Method for a Borderline BCS III/IV Drug Guided by Modeling and Simulations─Acyclovir as a Case Study. [PDF]

Mol Pharm
García MA, Tapia F, Escares B, Langguth P.   +3 more
europepmc   +1 more source

Physiologically Based Biopharmaceutics Modelling-Best Scientific Practices to Define Drug Product Performance, Latest Regulatory and Industry Perspectives: Workshop Summary Report. [PDF]

Pharmaceutics
McAllister M, Mistry N, Pepin X, Cole S, Tannergren C, Stamatopoulos K, Engman H, Moir A, Litou C, Gavins F, Arora S, Malamatari M, Guimarães M, Ravi A, Fotaki N, Dodd L, Holte Ø, Butler J, Dickinson PA, Popkin M, Butler A, NiOgain O, Holmstock N, Mackie C.   +23 more
europepmc   +1 more source

Popping FVIII concentrates into an updated classification. [PDF]

Blood Adv
Croteau SE.
europepmc   +1 more source

Global Trends in Integrating Machine Learning (ML) with Model-Informed Drug Development (MIDD): A Bibliometric and Systematic Review (2015-2025). [PDF]

Pharmaceutics
Dermawan D, Chtita S, Alotaiq N.
europepmc   +1 more source

Training the next-generation of biomedical scientists through artificial intelligence-driven education and research in pharmacology and pharmaceutical sciences. [PDF]

Exp Biol Med (Maywood)
Kumar S, Karwasra R, Zhou W, Seetharaman J, Singla B.   +4 more
europepmc   +1 more source

Development of in vitro-in vivo correlation for establishing patient-centric quality standards of dissolution for lamotrigine extended-release tablets. [PDF]

Eur J Pharm Biopharm
Zidan A, Siddique AB, Shaklah M, Anand O, O'Connor T, Ashraf M.   +5 more
europepmc   +1 more source

Virtual Bioequivalence Assessment of Long-acting Injectable Suspensions Using PBPK Modeling: Part 2. Type 1 Error and Safe space Analyses

We present an analysis of statistical type I error and safe space calculations in virtual bioequivalence (VBE) assessments using a previously published physiologically-based pharmacokinetic (PBPK) model (1) for 3-month long-acting paliperidone palmitate (PP) injectable suspensions. The type I error for the two-one-sided t test (TOST) applied to virtual
Morris, Natalie M., Jamei, Masoud, Alam, Khondoker, Tsakalozou, Eleftheria, Donnelly, Mark, Feng, Kairui, Bois, Frederic Yves   +6 more
openaire   +1 more source

Mechanistic Modelling of Lidocaine and Prilocaine Absorption from EMLA Cream upon Topical Application using Physiologically Based Pharmacokinetic Modelling. [PDF]

AAPS PharmSciTech
Telaprolu KC, Tsakalozou E, Ghosh P, Alam K, Grice JE, Roberts MS, Jamei M, Polak S, Clarke JF.   +8 more
europepmc   +1 more source

Development of a Physiologically Based Biopharmaceutics Model Report Template: Considerations for Improved Quality in View of Regulatory Submissions. [PDF]

Mol Pharm
Arora S, Pepin X, Jamei M, Sharma P, Heimbach T, Wagner C, Bransford P, Kollipara S, Ahmed T, Hingle M, Dallmann A, Scherholz M, Stamatis SD, Cano-Vega M, Mistry N, Tannergren C, Borges L, Lindahl A, Rullo G, Mackie C, Mitra A, Kushner J, Harish Jain KM, Polli JE.   +23 more
europepmc   +1 more source

Bioequivalence of alternative pembrolizumab dosing regimens: current practice and future perspectives. [PDF]

Cancer Commun (Lond)
Malmberg R, Agema BC, Hofman MM, Oosterveld S, Bins S, Dumoulin DW, Joosse A, Aerts JGJV, Debets R, Koch BCP, van der Veldt AAM, van Leeuwen RWF, Mathijssen RHJ.   +12 more
europepmc   +1 more source