The ability to estimate systemic exposure from dermal absorption is essential in developing new dermatological medications or assessing the toxicological liability of commercially-used chemicals. Historically, animal models were used to evaluate dermal drug absorption prior to clinical testing. However, both differences in human and animal physiology as well as ethical concerns over animal testing have […]
Read MoreAuthors: Nikunjkumar Patel
What’s New in the Simcyp Simulator v17?
Watch this webinar with Nikunjkumar Patel, Oliver Hatley, and Matthew Harwood to learn how the latest updates in the Simcyp Simulator v17 will help provide insights that support developing safer, more effective medications.
Read MoreQuantitative Prediction of Dermal Drug Absorption Using MPML-MechDermA Model: Relative Effects of Application Site on Rivastigmine Pharmacokinetics from a Transdermal Delivery System
Development and Verification of PBPK Model for a Topical Cream Formulation of Trifarotene to Simulate Local and Systemic Exposure and Model Application to Simulate Potential CYP-mediated Drug-drug Interactions
Development and Validation of a Dermal PBPK Model for Prediction of the Hair Follicular Absorption of Caffeine: Application of the Simcyp MechDermA Model
Multi-phase Multi-layer MechDermA Model: Development, Verification and Application of a PBPK/PD Model of Dermal Absorption for Transdermal Product Assessment
Predicting Diclofenac Systemic and Synovial Fluid Concentrations After Dermal Application Using the Multi-phase Multi-layer MechDermA PBPK Model
Modeling & Simulation for Drug Development & Formulation
A look at how to leverage modeling and simulation technology to enhance all phases of the drug development process.
Read MoreAn 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 […]
Read MorePhysiologically-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 […]
Read MoreCommentary on “In Silico Modeling of Gastrointestinal Drug Absorption: Predictive Performance of Three Physiologically-based Absorption Models”
Early Assessment of Proarrhythmic Risk of Drugs Using the In Vitro Data and Single-cell-based In Silico Models: Proof of Concept
Mechanistic Modeling Using Classical Nucleation Theory of Fluid Dynamics and Dissolution Media Effects on Supersaturation and Precipitation Behavior Based upon a USP 2 Style Transfer Apparatus: A Simulation Exercise
Mechanistic Model-based Analysis of Biopharmaceutics Experiments – Application of In Vitro-In Vivo Extrapolation (IVIVE) Techniques within a PBPK Modeling 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 […]
Read MoreReal Patients & Their Virtual Twins: A New Paradigm for Personalized Drug Safety Assessment
June 19, 2018 – In this webinar, Sebastian Polak, Nikunj Patel, and Mark Holbrook will introduce the Cardiac Safety Simulator (CSS) platform and explain how they developed a QSTS model for citalopram to serve as a “virtual twin” and help predict the likely occurrence of cardiotoxic events in real patients under different clinical conditions.
Read MoreIn Vitro/In Vivo Extrapolation (IVIV_E) of API Dissolution within a PBPK Framework
Towards Development and Validation of the Dermal PBPK Model for Virtual Bioequivalence—Model Description and Validation Case Studies
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.
Read More