The application of in silico modeling to predict the in vivo outcome of an oral drug product is gaining a lot of interest. Fully relying on these models as a surrogate tool requires continuous optimization and validation. To do so, intraluminal and systemic data are desirable to judge the predicted outcomes.
openaire +2 more sources
A review of OSP suite PBBM capabilities: looking ahead
Stephan Schaller +3 more
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Mechanism-Based Pharmacokinetic and Pharmacodynamic Modeling. [PDF]
Ćwierczek A.
europepmc +1 more source
Narrow Therapeutic Index Drugs: Regulatory Frameworks, Bioequivalence, and Model-Informed Precision Dosing. [PDF]
Liu M +7 more
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Yoshinori Takahashi +3 more
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Evaluation of USP 3 Apparatus to Develop Biopredictive Fasted and Fed Dissolution Methods for Extended-Release Desvenlafaxine Succinate Tablets. [PDF]
Carapeto GV +4 more
europepmc +1 more source
Physiologically Based Pharmacokinetic Modeling of Efavirenz Nanoparticles: from Animal Model to Human Extrapolation. [PDF]
da Silva TM +8 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]
Zidan A +5 more
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Efficient production of gene-edited onion (Allium cepa) plants using biolistic delivery of cas9 RNPs and transient expression constructs. [PDF]
De La Mora CL, Havey MJ, Krysan PJ.
europepmc +1 more source
Advances in Physiologically Based Pharmacokinetic (PBPK) Modeling and its Regulatory Utility to Support Oral Drug Product Development and Harmonization. [PDF]
Cheng YH +16 more
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