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Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program

Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation…

CertaraJune 22, 2021

On-Demand Webinar

PBPK modeling approaches to assess risks associated with bioequivalence in drug development

In this webinar, Dr. Ioannis Loisios-Konstantinidis from Novartis, Switzerland discussed: Opportunities and challenges in conducting…

CertaraMay 19, 2021

Publication

Opening a debate on open‐source modeling tools: Pouring fuel on fire versus extinguishing the flare of a healthy debate

As model‐informed drug development becomes an integral part of modern approaches to the discovery of…

CertaraMay 13, 2021

On-Demand Webinar

A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development

Pediatric PBPK models have broad application in the drug development process and are being used…

CertaraApril 20, 2021

White Paper

Overcome Research Hurdles: Expert Guidance for Complex Generic Drug Development

Do expensive bioequivalence studies stall your generic drug approval? Learn how you can streamline complex…

CertaraApril 15, 2021

On-Demand Webinar

Predicting the Effect of the Dulaglutide-Mediated Gastric Emptying Delay on Drug Exposure

The European Medicines Agency (EMA) recently approved dulaglutide (Trulicity®) at higher doses (3 mg and…

CertaraApril 1, 2021

Publication

Physiologically- based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

CertaraMarch 16, 2021

On-Demand Webinar

IQ WG Evaluation of PBPK Models for Organ-Impaired Populations

• The predictive performance of physiologically based pharmacokinetic(s) (PBPK) models for PK in renal impairment…

CertaraMarch 10, 2021

White Paper

Advancing Pediatric Drug Development Using Simcyp® PBPK

CertaraMarch 4, 2021

Brochure

Simcyp® PBPK Simulator

Streamlines drug development by using PBPK modeling to predict drug behavior in virtual populations, optimize…

CertaraJanuary 22, 2021

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