Results 121 to 130 of about 23,818,397 (163)

Accelerating Subcutaneous Drug Development: A Mechanistic Absorption Model for the Open Systems Pharmacology Framework. [PDF]

CPT Pharmacometrics Syst Pharmacol
Pellowe M, Dubbelboer I, Sjögren E.
europepmc   +1 more source

Application of New Approach Methodologies to Improve Oral Biopharmaceutic Assessments. [PDF]

Pharmaceutics
García MA, Cabrera-Pérez MÁ, González PM, Aceituno A, Hachim D.   +4 more
europepmc   +1 more source

Is a Clinical Trial With a Non-Bioequivalent Batch Necessary? The Critical Role of Intrasubject Variability in Olaparib Formulation Bridging by PBPK. [PDF]

Clin Pharmacol Ther
Dong J, Moir A, Pepin X, Lowe E, Hopkins S, Tang W, Zhou D.   +6 more
europepmc   +1 more source

Narrow Therapeutic Index Drugs: Regulatory Frameworks, Bioequivalence, and Model-Informed Precision Dosing. [PDF]

Pharmaceutics
Liu M, Wang Z, Chen Y, Jia Y, Xu L, Xu H, Li J, Zhao L.   +7 more
europepmc   +1 more source

Open Systems Pharmacology Community Conference (OSP-CC) Proceedings 2025. [PDF]

CPT Pharmacometrics Syst Pharmacol
Cordes H, Annaert P, Balazki P, Benamara S, Bonan RH, Butler A, Chenel M, Cui Y, Dallmann A, de Witte WEA, Demeester C, Feick D, Gattacceca F, Geci R, Gerebtzoff G, Gruber A, Guimarães M, Hamadeh A, Hanke N, Ibarra M, Ince I, Kanacher T, Kuepfer L, Mil F, Montaseri G, Nauwelaerts N, Proenca S, Schaller S, Schlender JF, Schneider ARP, Sjögren E, Solodenko J, Staab A, Vrenken P, Troisi C, Teutonico D.   +35 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

PK-Informed Microphysiological Systems: From Dynamic Dosing to Quantitative In Vitro-In Vivo Translation. [PDF]

Pharmaceutics
Kang SJ, Bong S, Jo MJ, Lee JM, Yoon MS, Park S, Lee Y, Shin Y, Lee HJ, Park CW, Shin DH.   +10 more
europepmc   +1 more source

Development and Evaluation of Physiologically Based Pharmacokinetic (PBPK) Models of Metoclopramide Across the Lifespan: Translation from Adults to Infants. [PDF]

Pharmaceuticals (Basel)
Shahzad I, Zamir A, Rasool MF, Alshamrani AA, Hussain I, Alqahtani F.   +5 more
europepmc   +1 more source

Formalizing method choice: a data-driven selection of mechanistic models for predicting human heart drug partitioning. [PDF]

J Pharmacokinet Pharmacodyn
Ulaszek S, Lisowski B, Jesionek M, Wiśniowska B, Polak S.   +4 more
europepmc   +1 more source

From animal testing to model-informed drug development: building on ICH M15 and EMA initiatives to make new approach methodologies (NAMs) deliver. [PDF]

Front Pharmacol
Dogné JM, Locquet M, Musuamba F, Beken S.   +3 more
europepmc   +1 more source