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In vitro to in vivo extrapolation to derive a metabolism factor for estimating the aggregate exposure to salicylic acid after dermal exposure of its esters
As part of the safety assessment of salicylate esters in cosmetics, we developed a metabolism factor based on in vitro to in vivo extrapolation...
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In vitro to in vivo extrapolation and high-content imaging for simultaneous characterization of chemically induced liver steatosis and markers of hepatotoxicity
Chemically induced steatosis is characterized by lipid accumulation associated with mitochondrial dysfunction, oxidative stress and nucleus...
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Towards best use and regulatory acceptance of generic physiologically based kinetic (PBK) models for in vitro-to-in vivo extrapolation (IVIVE) in chemical risk assessment
With an increasing need to incorporate new approach methodologies (NAMs) in chemical risk assessment and the concomitant need to phase out animal...
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Establishing relationships between particle-induced in vitro and in vivo inflammation endpoints to better extrapolate between in vitro markers and in vivo fibrosis
BackgroundToxicity assessment for regulatory purposes is starting to move away from traditional in vivo methods and towards new approach...
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In Vitro to In Vivo Extrapolation Linked to Physiologically Based Pharmacokinetic Models for Assessing the Brain Drug Disposition
Drug development for the central nervous system (CNS) is a complex endeavour with low success rates, as the structural complexity of the brain and...
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Antiviral neutralizing antibodies: from in vitro to in vivo activity
Neutralizing antibodies (nAbs) are being increasingly used as passive antiviral reagents in prophylactic and therapeutic modalities and to guide...
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Uridine 5′-Diphospho-glucuronosyltransferase 1A3 (UGT1A3) Prediction of Hepatic Clearance of Organic Anion Transporting Polypeptide 1B3 (OATP1B3) Substrate Telmisartan by Glucuronidation Using In Vitro–In Vivo Extrapolation (IVIVE)
Background and ObjectiveThe prediction of pharmacokinetic parameters for drugs metabolised by cytochrome P450 enzymes has been the subject of active...
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In Vitro In Vivo Extrapolation and Bioequivalence Prediction for Immediate-Release Capsules of Cefadroxil Based on a Physiologically-Based Pharmacokinetic ACAT Model
Physiologically based pharmacokinetic (PBPK) modeling is a mechanistic concept, which helps to judge the effects of biopharmceutical properties of...
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In Vitro - in Vivo Extrapolation of Hepatic Clearance in Preclinical Species
Accurate prediction of human clearance is of critical importance in drug discovery. In this study, in vitro – in vivo extrapolation (IVIVE) of...
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In Vitro-In Vivo Extrapolation and Scaling Factors for Clearance of Human and Preclinical Species with Liver Microsomes and Hepatocytes
In vitro - in vivo extrapolation ((IVIVE) and empirical scaling factors (SF) of human intrinsic clearance (CL int ) were developed using one of the...
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In vitro toxicology: Next generation models and methods to improve safety evaluation
With the advent of molecular and cellular toxicology, the field of drug safety evaluation has been undergoing an important paradigm shift, which has...
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In Vitro and In Vivo Metabolism Studies
Drug metabolism studies play a critical role in the discovery and development of new chemical entities. These studies provide in-depth understanding...
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Refining the in vitro release test method for a dapivirine-releasing vaginal ring to match in vivo performance
Previously reported in vitro release test methods for drug-releasing vaginal rings containing poorly water-soluble drugs have described use of...
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In Vitro to In Vivo Extrapolation of Metabolic Clearance for UGT Substrates Using Short-Term Suspension and Long-Term Co-cultured Human Hepatocytes
The use of micro-patterned co-cultured hepatocytes for human hepatic clearance predictions has previously been demonstrated using drugs metabolized...
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Biopharmaceutics Risk Assessment—Connecting Critical Bioavailability Attributes with In Vitro, In Vivo Properties and Physiologically Based Biopharmaceutics Modeling to Enable Generic Regulatory Submissions
Quality risk assessment following ICH Q9 principles is an important activity to ensure optimal clinical efficacy and safety of a drug product....
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An In Silico Platform to Predict Cardiotoxicity Risk of Anti-tumor Drug Combination with hiPSC-CMs Based In Vitro Study
ObjectiveAntineoplastic agent-induced systolic dysfunction is a major reason for interruption of anticancer treatment. Although targeted anticancer...
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Prediction of the dose range for adverse neurological effects of amiodarone in patients from an in vitro toxicity test by in vitro–in vivo extrapolation
Amiodarone is an antiarrhythmic agent inducing adverse effects on the nervous system, among others. We applied physiologically based pharmacokinetic...
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Comprehensive interpretation of in vitro micronucleus test results for 292 chemicals: from hazard identification to risk assessment application
Risk assessments are increasingly reliant on information from in vitro assays. The in vitro micronucleus test (MNvit) is a genotoxicity test that...
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Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation
BackgroundThe development of generic ophthalmic drug products is challenging due to the complexity of the ocular system, and a lack of sensitive...
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Multi-Well Array Culture of Primary Human Hepatocyte Spheroids for Clearance Extrapolation of Slowly Metabolized Compounds
Accurate prediction of human pharmacokinetics using in vitro tools is an important task during drug development. Albeit, currently used in vitro ...
