Drug-Drug Interactions (DDI) Archives

Case Study

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating…

CertaraAugust 12, 2021

Case Study

DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®)

Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…

CertaraJuly 29, 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

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

Case Study

Galderma Achieves FDA Approval of AKLIEF® (trifarotene)

In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the…

CertaraNovember 9, 2020

Publication

Metformin and Cimetidine: Physiologically-based Pharmacokinetic Modeling to Investigate Transporter Mediated Drug–drug Interactions

CertaraJune 1, 2016

Blog

Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko

Pharmacometrics uses mathematical models of biology, pharmacology, disease, and physiology to describe and quantify interactions…

CertaraDecember 1, 2015

Publication

Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part II—Prediction of P-glycoprotein Mediated Drug-drug Interactions with Digoxin

Digoxin is the recommended substrate for assessment of P-glycoprotein (P-gp)-mediated drug-drug interactions (DDIs) in vivo.…

CertaraSeptember 1, 2013

Publication

A Mechanistic Framework for In Vitro-In Vivo Extrapolation of Liver Membrane Transporters: Prediction of Drug-drug Interaction Between Rosuvastatin and Cyclosporine

The interplay between liver metabolizing enzymes and transporters is a complex process involving system-related parameters such as liver blood perfusion…

CertaraJuly 24, 2013

Drug-Drug Interactions (DDI)

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®)

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

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

Galderma Achieves FDA Approval of AKLIEF® (trifarotene)

Metformin and Cimetidine: Physiologically-based Pharmacokinetic Modeling to Investigate Transporter Mediated Drug–drug Interactions

Back to the Future (of Pharmacometrics) with Dr. Lawrence Lesko

Application of Permeability-limited Physiologically-based Pharmacokinetic Models: Part II—Prediction of P-glycoprotein Mediated Drug-drug Interactions with Digoxin

A Mechanistic Framework for In Vitro-In Vivo Extrapolation of Liver Membrane Transporters: Prediction of Drug-drug Interaction Between Rosuvastatin and Cyclosporine

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