FDA Precision Dosing Workshop

The Food and Drug Administration, Office of Clinical Pharmacology/OTS/CDER

This workshop will discuss the need for precision dosing, solutions, and translating real world dosing to patient drug dosing tools.

FDA Building 1

<p>Various clinical trials are conducted to optimize the dosing regimen to balance the benefit and risk of a new drug for the target patient population. Clinical pharmacology trials serve as the major source of evidence for dose individualization (precision dosing) based on both extrinsic and intrinsic factors that can modify the drug exposure and potentially the effectiveness and safety of the new drug for an individual patient. Despite the efforts for dose optimization in the pre-market setting, there still exists the general need for dose optimization in the post-market space, e.g. extremes of age, size, organ function and complex multiple characteristics including genotype, drug interactions, and co-morbidities. The limitations of the current labeled dosing will be discussed from multiple perspectives including drug developers, regulators, physicians, pharmacists and patients.  These relevant groups will also discuss the need for precision dosing, the challenges of generating evidence to support precision dosing and applying individualized dosing regimen in clinical practice. In addition to evidence created during the new drug development process, real-world data/evidence will be discussed to address some challenges that cannot be addressed by the pre- and post-marketing clinical trials. Process of translating the knowledge to products or tools that can be utilized by the medical community for patient care will also be discussed.</p>

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Registrations are closed

FDA Precision Dosing Workshop

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Registrations are closed

FDA Precision Dosing Workshop

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