Clinical Pharmacology

The MIE Shift: When the Model Becomes the Primary Evidence for FDA Approval

Clinical Pharmacology, Drug Development Strategy, Regulatory /

Executive Summary For a long time, the pharmaceutical industry viewed Clinical Pharmacology models as helpful supporting characters. They were tools used to guide a trial design or help justify a specific dose. As we move through 2026, a fundamental shift has taken place. The FDA and EMA have moved from Model Informed to Model Integrated […]

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The Quiet Risk in 2026 INDs: When Clinical Pharmacology Is Treated as a Deliverable Instead of a Strategy

Clinical Pharmacology /

Many 2026 INDs are already being scoped. Budgets are being finalized, CROs are being shortlisted, and timelines are being compressed. In that environment, clinical pharmacology often becomes something to be delivered rather than something to be designed. Analyses are commissioned because the IND needs them, not because a decision requires them. The risk here is

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