Model Informed Drug Development Archives

Publication

Accounting for Transporters in Renal Clearance: Towards a Mechanistic Kidney Model (Mech KiM)

The impact of transporters in modulating the disposition of drugs in the liver and their…

Danielle Pillsbury2013 年 8 月 20 日

Publication

Temporal Profile of Lymphocyte Counts and Relationship with Infections with Fingolimod Therapy

Reduction in peripheral blood lymphocytes is an expected pharmacodynamic outcome of fingolimod therapy. The objective…

Danielle Pillsbury2013 年 8 月 15 日

Publication

Basic Concepts in Physiologically-based Pharmacokinetic Modeling in Drug Discovery and Development

The aim of this tutorial is to introduce the concept of physiologically based pharmacokinetic (PBPK)…

Danielle Pillsbury2013 年 8 月 1 日

Publication

Clinical Trial Simulation to Inform Phase 2: Comparison of Concentrated vs. Distributed First-in-patient Study Designs in Psoriasis

Clinical trial simulation (CTS) and model-based meta-analysis (MBMA) can increase our understanding of small, first-in-patient…

Danielle Pillsbury2013 年 7 月 24 日

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…

Danielle Pillsbury2013 年 7 月 24 日

Publication

Model-based Drug Development: A Rational Approach to Efficiently Accelerate Drug Development

The pharmaceutical industry continues to face significant challenges. Very few compounds that enter development reach…

Danielle Pillsbury2013 年 7 月 1 日

Publication

The Simcyp Population-based Simulator: Architecture, Implementation, and Quality Assurance

Developing a user-friendly platform that can handle a vast number of complex physiologically based pharmacokinetic…

Danielle Pillsbury2013 年 6 月 3 日

Publication

Evaluation of an In Silico PBPK Postbariatric Surgery Model through Simulating Oral Drug Bioavailability of Atorvastatin and Cyclosporine

An increasing prevalence of morbid obesity has led to dramatic increases in the number of…

Danielle Pillsbury2013 年 6 月 1 日

Publication

Characterizing Systemic Exposure of Inhaled Drugs: Application to the Long-acting β2-agonist PF-00610355

PF-00610355 is an orally inhaled long-acting β2-adrenoreceptor agonist that is being developed for the once-daily…

Danielle Pillsbury2013 年 6 月 1 日

Publication

The Future of the Pharmaceutical Sciences and Graduate Education: Recommendations from the AACP Graduate Education Special Interest Group

Despite pharma's recent sea change in approach to drug discovery and development, U.S. pharmaceutical sciences…

Danielle Pillsbury2013 年 5 月 13 日

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模型引导的药物开发

Accounting for Transporters in Renal Clearance: Towards a Mechanistic Kidney Model (Mech KiM)

Temporal Profile of Lymphocyte Counts and Relationship with Infections with Fingolimod Therapy

Basic Concepts in Physiologically-based Pharmacokinetic Modeling in Drug Discovery and Development

Clinical Trial Simulation to Inform Phase 2: Comparison of Concentrated vs. Distributed First-in-patient Study Designs in Psoriasis

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

Model-based Drug Development: A Rational Approach to Efficiently Accelerate Drug Development

The Simcyp Population-based Simulator: Architecture, Implementation, and Quality Assurance

Evaluation of an In Silico PBPK Postbariatric Surgery Model through Simulating Oral Drug Bioavailability of Atorvastatin and Cyclosporine

Characterizing Systemic Exposure of Inhaled Drugs: Application to the Long-acting β2-agonist PF-00610355

The Future of the Pharmaceutical Sciences and Graduate Education: Recommendations from the AACP Graduate Education Special Interest Group

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