January 2020

Certara’s Simcyp MechDermA Model Achieves Regulatory Approval: Demonstrates Virtual Bioequivalence in Dermal Drug Development

January 29, 2020

Demonstrating bioequivalence (BE) remains the key regulatory hurdle for generic drug approval. However, this is a challenging process for today’s complex drugs and alternative delivery methods. Consequently, patients lack availability of thousands of generics. This problem is especially vexing for topical drugs and trans-dermal patches. Regulatory Support for Expediting the Development of Dermal Generics The … Continued

How to Demonstrate Virtual Bioequivalence for Complex Dermal Generic Drugs

January 24, 2020

By webdev

This webinar will explain how Certara expanded its PBPK Simcyp Simulator to incorporate an extensive dermal model— MPML MechDermA, a multi-phase, multi-dimensional dermal absorption model.

Certara Supported 90+ Percent of US FDA Novel New Drug Approvals for Sixth Consecutive Year

January 23, 2020

By webdev

PRINCETON, NJ – Jan. 23, 2020 – Certara today reported that more than 90% of novel new drug approvals by the US Food and Drug Administration (FDA) in 2019 were supported by Certara software or services.

Visualization of Complex Trial Data in Non-Linear Mixed-Effect Analyses With Covariates

January 17, 2020

By webdev

Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110

January 17, 2020

By webdev

Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing

January 17, 2020

By webdev

Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing

Certara’s Best of the Blog 2019

January 10, 2020

By webdev

A selection of short essays from our blog, written to empower our clients with modeling and simulation (M&S), regulatory science, and real-world value assessment solutions to help them solve the toughest drug development problems. In the Best of the Blog, Certara’s scientists and regulatory experts share their learnings, technological advances, and thought leadership.

Certara Partners with Galderma to Attain FDA Approval of AKLIEF® Topical Acne Cream

January 8, 2020

By webdev

PRINCETON, NJ – Jan. 8, 2020 – Certara’s Simcyp® Simulator’s MechDermA™ model provided safety label claim and pediatric dosing information without the need for testing in clinical patients for a topical drug product.

Ministry of Health of Ukraine Order 1528 for Public Release of Trial Results

January 7, 2020

By Jessica Walsh

By Nirpal Virdee, Global Head of Transparency & Disclosure Over the past several years, Ukraine has taken significant steps with its healthcare services in hopes of matching the high quality, modern healthcare provided in leading western countries. The Ministry of Health (MoH) of Ukraine continues to invest heavily in this ambitious goal. New legislation in … Continued

Prescription Drug Pricing: “The Times They Are A-Changin”

January 7, 2020

By Ulrich Neumann

“Come senators, congressmen Please heed the call Don’t stand in the doorway Don’t block up the hall For he that gets hurt Will be he who has stalled” Bob Dylan recorded his iconic “The Times They Are a Changin’” in 1963; the song was released on the 1964 album by the same name. One of … Continued

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Month: January 2020