Clinical Pharmacology Strategy

Mind the Gap: Best Practices in Clinical Pharmacology Gap Analysis

Julie Bullock

Do you get anxious about taking tests? Many people do because they want to show their best efforts. Submitting your New Drug Application (NDA) to the FDA can be thought of as the ultimate test of a drug program. Are you confident that you’ll have robust answers to the 40 different questions that the agency […]

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Topics: Clinical Pharmacology Strategy

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

How Biosimulation Technology Impacted the “Class of ’15”

Ellen Leinfuss

It’s been almost 20 years since the FDA approved a group of New Drug Applications (NDA) and Biologic License Applications (BLA) as large as the class of ’15. The 45 approved drugs represent a 10% increase over the prior year and an increase of 114% from the beginning of the decade. What accounts for this […]

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