Certara

Optimize Immuno-oncology Drug Discovery and Development Using Quantitative Systems Pharmacology

A Quantitative Systems Pharmacology (QSP) approach for developing combination immune-oncology therapies can be used to better predict effective drug combinations, especially to more accurately correlate the physiological differences between preclinical models and human patients.

Author(s): Piet van der Graaf, Andrzej Kierzek

Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology

Therapeutic Area: Oncology/Hematology, Rare/Orphan Disease

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PBPK’s Pivotal Role in Modern Drug Development: Busting Common Myths and Misconceptions

This white paper addresses common PBPK myths and misconceptions and demonstrates how this approach is an industrial and regulatory necessity in modern drug development.

Author(s): Amin Rostami-Hodjegan, Masoud Jamei, Thomas Polasek

Solution: PBPK Modeling & Simulation

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Managing Immunogenicity Using Quantitative Systems Pharmacology

Biologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.

Author(s): Piet van der Graaf, Andrzej Kierzek, Timothy Hickling

Solution: Drug Development & Regulatory Strategy, Model-informed Drug Development, Molecular Modeling & Simulation, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology

Therapeutic Area: Cardiovascular, Central Nervous System, Dermatology, Endocrinology, Infectious Disease, Oncology/Hematology, Pediatrics, Rare/Orphan Disease

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The Model-informed Drug Development Imperative in Oncology R&D

The impact of MIDD is especially powerful in oncology, where numerous cases demonstrate its enormous value in streamlining and accelerating the development cycle and supporting breakthrough therapy options for these fragile patients.

Solution: Model-informed Drug Development

Therapeutic Area: Oncology/Hematology

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The Modernization of Orphan Drug Development

Orphan drugs affect 350,000 people worldwide, including 10% of the US population and 1 in 25 Europeans. Model-informed drug development (MIDD) approaches, such as PBPK and PopPK have been embraced by sponsors and regulators, and play a key role in modernizing and accelerating orphan drug development.

Author(s): Maria Saluta

Solution: Clinical Pharmacology Strategy, PBPK Modeling & Simulation, PK/PD Modeling & Simulation

Therapeutic Area: Pediatrics, Rare/Orphan Disease

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Predictive Toxicology: Bringing Chemical Risk Assessment into the 21st Century

Traditional toxicology methods, using in vivo animal testing, is an unrealistic approach to predict chemical risk assessment. Mechanistic modeling and simulation tools such as PBPK and QST can expedite toxicological screening, support the prioritization for testing compounds that merit greater study, and reduce unnecessary animal testing.

Author(s): Maria Saluta

Solution: PBPK Modeling & Simulation

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The Use of Model-informed Precision Dosing to Improve Patient Drug Treatment Outcomes

Precision dosing is a crucial cornerstone of precision medicine that will provide patients the most efficacious medications with minimum probability of adverse events. Model-informed precision dosing, using quantitative modeling and simulation approaches, such as PBPK and NLME, can improve precision dosing in clinical care.

Author(s): Maria Saluta

Solution: PBPK Modeling & Simulation, PK/PD Modeling & Simulation

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Best Practices for Developing High Quality, On Time Submissions

Sponsors often struggle with submission planning. Read this white paper to learn how to develop a plan that minimizes stress and increases your chances of regulatory success.

Author(s): Steve Sibley

Solution: Regulatory & Medical Writing

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Applying Model Reduction to Lessen the Complexity of Quantitative Systems Pharmacology Models

QSP models are inherently complex and difficult to use in a clinical setting. Rigorous model reduction methods alleviate the complexity, bolster the use of QSP models for valuable gains, resulting in the extraction of a practical useable model from biological understandings.

Solution: Systems Pharmacology

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Drug Asset Evaluation: Increasing “Probability of Success” of a Deal

Certara’s due diligence/asset evaluation teams are comprised of drug development and commercialization experts who advise on acquiring or investing in emerging biopharma companies.

Solution: Clinical Pharmacology Strategy, Model-based Meta-analysis, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing

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Optimize Immuno-oncology Drug Discovery and Development Using Quantitative Systems Pharmacology

PBPK’s Pivotal Role in Modern Drug Development: Busting Common Myths and Misconceptions

Managing Immunogenicity Using Quantitative Systems Pharmacology

The Model-informed Drug Development Imperative in Oncology R&D

The Modernization of Orphan Drug Development

Predictive Toxicology: Bringing Chemical Risk Assessment into the 21st Century

The Use of Model-informed Precision Dosing to Improve Patient Drug Treatment Outcomes

Best Practices for Developing High Quality, On Time Submissions

Applying Model Reduction to Lessen the Complexity of Quantitative Systems Pharmacology Models

Drug Asset Evaluation: Increasing “Probability of Success” of a Deal