PBPK Modeling & Simulation

The Ides of March—FDA’s Pharmaceutical and Clinical Pharmacology Advisory Committee Meeting

Ellen Leinfuss

While ominously scheduled for March 15, no such drama (like the assassination of Julius Caesar, the origins of ‘beware the Ides of March’) occurred during the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting. It was quite productive, acknowledging the tremendous impact of modeling and simulation in drug development and regulatory review moving the technology further into the mainstream.

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Topics: PBPK Modeling & Simulation

EMA Policy 0070 Compliance Tips from James Bond

Lora Killian

In many ways, the strategic planning required to comply with EMA Policy 0070―a requirement to publish anonymized versions of clinical study reports (CSRs) and other submission documents―is similar to a secret agent’s mission: sponsors must keep the identities of people named or referred to in those documents top-secret while maintaining the document’s clinical utility. In […]

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Topics: Regulatory & Medical Writing

Modeling Delayed Outcomes in PK/PD Studies Using DDEs

Shuhua Hu

Delays are ubiquitous in pharmacokinetics (PK) and pharmacodynamics (PD) studies. Transit compartment models, described by systems of ordinary differential equations, have been widely used to describe delayed outcomes in PK and PD studies. The obvious disadvantage for this type of model is it requires manually finding proper values for the number of compartments. In addition, […]

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Topics: PK/PD Modeling & Simulation

The Model-informed Precision Dosing Revolution Is Coming

Suzanne Minton

Modeling and simulation (M&S) has been widely accepted and adopted by biopharmaceutical companies and global regulatory agencies. However, its implementation in clinical care has been modest to date. Model-based approaches are essential to realize the goal of precision dosing—providing the right drug dose to maximize therapeutic benefit, while reducing risk for each individual patient. The […]

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