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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Pharmaceutical substances known as xenobiotics are predominantly lipophilic and nonionized. This enables them to permeate lipid bilayers, such as cell membranes, and interact with intracellular target receptors. Lipophilic drugs have an advantage in crossing biological barriers and reaching their intended sites of action. However, lipophilic drugs often have a restricted capacity for renal expulsion or elimination from the body. When these drugs enter the kidneys and undergo glomerular...
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Related Experiment Video

Updated: Aug 29, 2025

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Transforming Evidence Generation for Drug Label Changes: A Case Study.

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Summary
This summary is machine-generated.

Computer Modeling and Simulation (CM&S) can reduce clinical trial burden. The FDA accepted CM&S evidence for Afrezza® (insulin human) label change discussions, highlighting its potential in regulatory science.

Keywords:
AfrezzaComputer modeling and simulationDiabetesFDAInhaled insulinInsulinModel-informed drug development

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Area of Science:

  • Regulatory Science
  • Pharmacokinetics and Pharmacodynamics
  • Computational Science

Background:

  • Computer Modeling and Simulation (CM&S) offers a pathway to reduce patient burden in clinical trials and enhance regulatory decision-making.
  • The US Food and Drug Administration (FDA) initiated the Model-Informed Drug Development (MIDD) pilot program to integrate CM&S into regulatory processes.

Purpose of the Study:

  • To support a label change for the initial dose of Afrezza® (insulin human) using CM&S within the FDA's MIDD pilot program.
  • To evaluate the utility of a CM&S framework in generating evidence for regulatory submissions.

Main Methods:

  • Development of a simulation framework based on empirical data for Afrezza®.
  • Submission of the CM&S framework and supporting clinical data to the FDA for validation.
  • Engagement with the FDA through two meetings over four months as part of the MIDD pilot program.

Main Results:

  • The FDA found the simulation framework insightful and capable of predicting glycemic outcomes.
  • The simulation was deemed low-risk for the specific question of interest.
  • The FDA accepted the CM&S evidence and requested additional traditional clinical data for the proposed label change.

Conclusions:

  • CM&S is a credible method for generating evidence in regulatory decision-making.
  • Collaboration among stakeholders, including sponsors and the FDA, is crucial for advancing CM&S in regulatory science.
  • The MIDD pilot program demonstrates the potential of CM&S to benefit patients, sponsors, and regulatory agencies.