Results 91 to 100 of about 690 (120)

Effect of Hepatic Impairment on Trofinetide Exposures Using an In Silico Physiologically Based Pharmacokinetic Model. [PDF]

Adv Ther
Darwish M, Obianom ON, Youakim JM, Darling I, Lukacova V, Bradley H.   +5 more
europepmc   +1 more source

Exploring Tafamidis Effects Through PBPK-QSP Modelling. [PDF]

Pharmaceutics
Ulaszek S, Lisowski B, Wiśniowska B, Polak S.   +3 more
europepmc   +1 more source

Optimization of wet granulation process for manufacturing Rivaroxban generic immediate-release tablets using PBPK modeling and simulations. [PDF]

In Silico Pharmacol
Shiekmydeen J, Tanisha, Sharma S, Chakraborty K, Kannaiyan DC, Khan NA, Malayandi R.   +6 more
europepmc   +1 more source

PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations. [PDF]

Pharm Res
Wu F, Tsakalozou E, Burckart GJ, Žakelj R, Gaohua L, Sagawa K, Lukacova V, Vaithiyalingam S, Fan J, Fotaki N, Patel N, Fang L.   +11 more
europepmc   +1 more source

In Silico Research Is Rewriting the Rules of Drug Development: Is It the End of Human Trials? [PDF]

Cureus
Lakhan SE.
europepmc   +1 more source

Clinical Laboratory Parameter-Driven Machine Learning for Participant Selection in Bioequivalence Studies Among Patients With Gastric Cancer: Framework Development and Validation Study. [PDF]

JMIR AI
Shon B, Seong SJ, Choi EJ, Gwon MR, Lee HW, Park J, Chung HY, Jeong S, Yoon YR.   +8 more
europepmc   +1 more source

Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria

Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria
openaire  

Physiologically Based Biopharmaceutics Modeling to Demonstrate Virtual Bioequivalence and Bioequivalence Safe-space for Ribociclib which has Permeation Rate-controlled Absorption [PDF]

Journal of Pharmaceutical Sciences, 2022
A physiologically based biopharmaceutics model (PBBM) was developed to support formulation development of ribociclib, an orally bioavailable selective CDK4/6 inhibitor. Ribociclib is a weak base with moderate permeability and complete in vitro dissolution under stomach pH. GastroPlus™ was used to simulate the pharmacokinetics (PK) in healthy volunteers
Tycho Heimbach, Martin Mueller-Zsigmondy, Lars Blumenstein   +2 more
exaly   +3 more sources

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Virtual Bioequivalence Assessment of Elagolix Formulations Using Physiologically Based Pharmacokinetic Modeling

AAPS Journal, 2023
In lieu of large bioequivalence studies and exposing healthy postmenopausal women to additional drug exposure for elagolix coadministered with hormonal add-back therapy, physiologically based pharmacokinetic (PBPK) modeling was used with in vitro dissolution data to test for virtual bioequivalence.
Dwaipayan Mukherjee, Mohamad Shebley, Patrick Marroum   +2 more
exaly   +3 more sources