A look at how to leverage modeling and simulation technology to enhance all phases of the drug development process.
Read MoreModeling & Simulation for Drug Development & Formulation
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Authors: Nikunjkumar Patel
Mechanistic Model-Based Analysis of Biopharmaceutics Experiments – Application of In Vitro in Vivo Extrapolation (IVIV_E) Techniques Within A PBPK Modelling Framework
In vitro dissolution testing is a critical component of drug product development and is often used as a surrogate for in vivo performance. While the range of (USP) standard methods have been developed and tested for many years, no single dissolution test or apparatus comprehensively maps the in vivo behaviour of the range of compound […]
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An Integrated Approach to Mechanistically Model In Vitro Experiments and Incorporate Drug-specific Parameter Estimates within a PBPK Framework to Simulate In-Vivo Drug Dissolution
In vitro dissolution testing is a critical component of drug product development programs and is often used as a surrogate for in vivo performance. Consequently, mechanistic modelling of in vitro dissolution studies and informed data interpretation early in the formulation development process is crucial. The Simcyp In Vitro (Data) Analysis (SIVA) toolkit is a standalone […]
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Physiologically-Based Pharmacokinetic (PBPK) Modelling Approach for the Prediction of Small Intestinal Precipitation of Poorly Soluble Drugs – A Simulation Study of Posaconazole Using the Simcyp ADAM Model
Weakly basic poorly soluble drug compounds, such as posaconazole (POSA), may dissolve completely at fasted gastric pH but precipitate upon transit to higher small intestinal pH. A number of in vitro and in vivo methods have been used to study intestinal precipitation of poorly soluble drug compounds with a varying degree of complexity. This research […]
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Certara’s Best of Blogs 2015
A selection of short essays from our blog, written to empower our customers with biosimulation and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing.
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Application of Physiologically-based Absorption Modelling in the Development of an In Vitro-In Vivo Correlation (IVIVC) for Topiramate Controlled Release Matrix Tablets
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Depending on Feasibility Populate Physiological Databases From Open Sources (Task 4.5)
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Physiologically-based IVIVC at a Population Level – Deconvoluting in vivo Dissolution and Identifying Sources of Variability
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Mechanistic In Vitro-In Vivo Extrapolation (IVIV_E) of Dissolution within a PBPK Framework: Extrapolation of IR Danazol Dissolution in the USP-2 paddle apparatus to In Vivo Dissolution
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Towards mechanistic simulation and prediction of bioequivalence studies of topical formulations case study with two diclofenac formulations
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Pharmacokinetic (PK) and Pharmacodynamic (PD) Implications of Diurnal Variation of Gastric Emptying and Small Intestinal Transit Time for Quinidine Mechanistic Simulation
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Simcyp In Vitro (Data) Analysis (SIVA) Toolkit: Deciphering Dissolution Experiments and Translating Intrinsic Parameters into PBPK models
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Establishment of Virtual Bioequivalence Using Population-Based PBPK Modeling: Application to the Setting of Dissolution Limits
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Mechanistic modeling of dermal drug absorption using the Simcyp Multi-phase Multi-layer MechDermA model: Case study of a transdermal patch formulation of weak base drug timolol
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Quantitative Prediction of Circadian Variation Impacts on Pharmacokinetics (PK): Dependence on Route of Administration in the Case of BCS/BDDCS Class II and CYP3A4 Substrate Drug Nifedipine
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Simcyp Contributions to the European Innovative Medicines Initiative (IMI) Orbito Project (Oral Biopharmaceutics tools)
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Application of a PBPK/PD model describing the change in systolic blood pressure following administration of immediate release and controlled release nifedipine formulations
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Prediction of skin disposition after topical application of drugs Simcyp platform as a tool for capturing system information and safety assessment
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Establishing an In Vitro-In Vivo Correlation (IVIVC) for Tramadol Extended-Release Tablets: Conventional vs. Physiologically-based IVIVC
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Importance of formulation type, ionization at skin surface, binding to keratin along with thickness and lipid levels of skin layers in quantitative prediction of human dermal absorption of diclofenac and ibuprofen
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