PBPK Modeling & Simulation

SOT Annual Meeting and ToxExpo

0 comments. Click here to read/write comments.

Topics:

ASCEPT Annual Scientific Meeting

0 comments. Click here to read/write comments.

Topics:

FDA Renews and Expands Its Use of Certara Software to Facilitate New Drug and Biologics Regulatory Review

PRINCETON, NJ – Oct. 9, 2018 – Certara today announced that the US Food and Drug Administration (FDA) has renewed, and in many cases increased, its number of Certara software licenses for reviewing new drug and biologics applications.

0 comments. Click here to read/write comments.

Topics:

Combining Machine Learning and Mechanistic Modeling Approaches to Solve Real Life Problems and Assessment of the Local Tissue Binding and Its Influence on the Systemic Exposure after Topical Application of Drugs

0 comments. Click here to read/write comments.

Topics:

Performance Verification of Mechanistic Dermal Physiological Based Pharmacokinetic (PBPK) Model for Enhanced Understanding of Dermal Absorption: Prediction of Local Tissue Exposure after Topical Application of Acitretin

0 comments. Click here to read/write comments.

Topics:

Development of a PBPK Model for Docetaxel as a CYP3A Substrate and Accounting for Binding to Multiple Plasma Proteins

0 comments. Click here to read/write comments.

Topics:

Impact of Free Fatty Acids on Prediction of Unbound Fraction of Cefazolin and Diazepam in Plasma of Full-term Neonates

0 comments. Click here to read/write comments.

Topics:

Application of Feto-maternal Physiologically-based Pharmacokinetic Model to Predict Emtricitabine Concentration During Pregnancy

0 comments. Click here to read/write comments.

Topics:

Using Virtual Twin™ Technology for Model-informed Precision Dosing

Posted by Thomas Polasek

on Oct 5, 2018 8:00:04 AM

In a recent Expert Review of Clinical Pharmacology article, I assessed the status and future direction of precision dosing in clinical medicine.1 Model-informed precision dosing (MIPD) is a modeling and simulation (M&S) approach in healthcare that is used to predict the most effective and/or least toxic drug dose for a patient. MIPD could revolutionize healthcare […]

0 comments. Click here to read/write comments.

Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology

Managing Immunogenicity Using Quantitative Systems Pharmacology

Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.

0 comments. Click here to read/write comments.

Topics:

Clinical Pharmacology Gap Analysis: Your FAQs

Posted by Julie Bullock

on Sep 21, 2018 8:00:23 AM

As drug development has become more complex, with a higher risk of failure, greater uncertainty, and increased expense, the need for a quantitative and regulatory science-based strategy becomes clear. The first step in that performing that strategic assessment is a gap analysis and roadmap. Over the last couple of months, I’ve written a series of blog […]

0 comments. Click here to read/write comments.

Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation

Leveraging In Vitro Data to Improve Prediction of Drug Clearance in Renally-impaired Populations

This webinar focused on the impact of RI on substrates of organic cation transporter 2 (OCT2), one of the major renal transporters which has been shown to be affected—both in activity and expression—in RI in pre-clinical species and in vitro systems.

0 comments. Click here to read/write comments.

Topics:

Clinical Pharmacology Gap Analysis: Lessons Learned

Posted by Julie Bullock

on Aug 10, 2018 8:00:45 AM

Clinical pharmacology gap analysis is a tool for outlining your drug program’s needs, prioritizing these needs, and providing a framework for how to satisfy them. This tool can create value for drug development programs. While gap analysis can be performed at any point in the drug development continuum, early engagement is best for maximizing its benefits. […]

0 comments. Click here to read/write comments.

Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation

Beam Me Up, Scotty! Probing the Mechanisms of Transporter-mediated Drug Disposition

Posted by Matthew Harwood

on Jul 27, 2018 8:00:08 AM

Over the last 15 years, the importance of drug transporters has become paramount for understanding drug absorption, distribution into tissues, and in particular, drug-drug interactions (DDIs). In vitro-in vivo extrapolation (IVIVE) is an approach to link in vitro systems to the human in vivo situation using algorithms and physiologically-based scaling factors. In this blog, I […]

0 comments. Click here to read/write comments.

Topics: PBPK Modeling & Simulation

Precision Dosing in Clinical Medicine: Present and Future

0 comments. Click here to read/write comments.

Topics:

Real Patients & Their Virtual Twins: A New Paradigm for Personalized Drug Safety Assessment

In this webinar, Sebastian Polak, Nikunj Patel, and Mark Holbrook introduced the Cardiac Safety Simulator (CSS) platform and explained 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.

0 comments. Click here to read/write comments.

Topics:

Using M&S to Evaluate Oncology Drug Dosing

Posted by Maria Saluta

on Apr 13, 2018 8:00:06 AM

There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be altered in cancer patients due to demographic and physiological differences as compared to healthy volunteers, and (3) cancer patients face elevated drug-drug interaction (DDI) risk […]

0 comments. Click here to read/write comments.

Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation

Certara’s Best of the Blog 2017

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) 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 and sharing clinical trial results.

0 comments. Click here to read/write comments.

Topics:

Changing the Game in Drug Development

At Certara, we are innovators, dedicated to helping our clients develop new therapies and target unmet medical needs, expand existing therapies to other subpopulations, communicate scientific information in the language of regulatory success and market access, balance risk-benefit profiles, differentiate therapies from the competitive landscape, and unlock millions of dollars in R&D savings.

0 comments. Click here to read/write comments.

Topics:

Certara and Faculty from UNC Eshelman School of Pharmacy to Launch New Pharmacometrics Skills Competition at ASCPT 2018 Annual Meeting

PRINCETON, NJ – Mar. 12, 2018 – Certara today announced that it is partnering with faculty at the UNC Eshelman School of Pharmacy to launch the Model-informed Drug Development (MIDD) Gran Prix at the 2018 American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting.

0 comments. Click here to read/write comments.

Topics: