Certara Products - Simcyp Archives | Page 10 of 26

Case Study

Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta

Many cystic fibrosis (CF) patients take several medications at one time to manage symptoms and…

CertaraJuly 14, 2021

Case Study

Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies

In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the…

CertaraJuly 14, 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

Certara Products – Simcyp

Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta

Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies

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

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

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

Overcome Research Hurdles: Expert Guidance for Complex Generic Drug Development

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

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

IQ WG Evaluation of PBPK Models for Organ-Impaired Populations

Advancing Pediatric Drug Development Using Simcyp® PBPK

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