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Related Concept Videos

Pharmacokinetic Models: Overview01:20

Pharmacokinetic Models: Overview

627
Pharmacokinetic models utilize mathematical analysis to achieve a detailed quantitative understanding of a drug's life cycle within the body. They are instrumental in simulating a drug's pharmacokinetic parameters, predicting drug concentrations over time, optimizing dosage regimens, linking concentrations with pharmacologic activity, and estimating potential toxicity.
There are three primary types of models: empirical, compartment, and physiological. Empirical models, with minimal...
627
One-Compartment Open Model for IV Bolus Administration: General Considerations01:19

One-Compartment Open Model for IV Bolus Administration: General Considerations

175
The one-compartment model is a pharmacokinetic tool that models the body as a single, uniform compartment, facilitating the understanding of drug distribution and elimination. This model is particularly beneficial for intravenous (IV) bolus administration, where the drug rapidly circulates throughout the body.
The drug's presence in the body is defined by an equation representing the difference between the rates of drug entry and exit. Key parameters—elimination rate constant,...
175
Drug Delivery: Parenteral Route01:29

Drug Delivery: Parenteral Route

450
The parenteral route is a critical method of drug administration. It delivers compounds directly into the systemic circulation and bypasses the gastrointestinal tract. This approach is particularly advantageous for drugs that exhibit poor absorption or instability when administered orally.
There are three primary parenteral routes: intravenous (IV), intramuscular (IM), and subcutaneous (SC). The IV route introduces the drug directly into the bloodstream, ensuring immediate action. The IM route...
450
Biopharmaceutics and Pharmacokinetics: Overview01:28

Biopharmaceutics and Pharmacokinetics: Overview

1.9K
Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
1.9K
One-Compartment Open Model for IV Bolus Administration: Estimation of Elimination Rate Constant, Half-Life and Volume of Distribution01:09

One-Compartment Open Model for IV Bolus Administration: Estimation of Elimination Rate Constant, Half-Life and Volume of Distribution

228
The one-compartment open model is a simplified approach used in pharmacokinetics to understand the distribution and elimination of a drug administered through an intravenous bolus. This model assumes rapid drug dispersal throughout the body and elimination using a first-order process. Key pharmacokinetic parameters, such as the elimination rate constant (k), half-life (t1/2), and the apparent volume of distribution (Vd), can be estimated from this model. The elimination rate is calculated...
228
Two-Compartment Open Model: IV Bolus Administration01:18

Two-Compartment Open Model: IV Bolus Administration

434
The two-compartment model for intravenous (IV) bolus administration illustrates drug distribution in the body, subdividing it into central and peripheral compartments. This model operates on the concept of two-compartment kinetics. The drug's plasma concentration shows a bi-exponential decline following IV bolus administration, signaling the presence of two disposition processes: distribution and elimination.
The disparity between drug input and the sum of drug transfer rates between...
434

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Related Experiment Video

Updated: Jun 16, 2025

The Quantification of Injectability by Mechanical Testing
04:46

The Quantification of Injectability by Mechanical Testing

Published on: May 13, 2020

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Leveraging Model Master Files for Long-Acting Injectables.

Yuqing Gong1, Robert Hopefl1, Tonglei Li2

  • 1Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, , MD, 20993, USA.

Pharmaceutical Research
|January 28, 2025
PubMed
Summary
This summary is machine-generated.

The U.S. Food and Drug Administration (FDA) and CRCG explored Model Master Files (MMFs) for regulatory submissions. MMFs show promise for improving model sharing and efficiency in drug development, particularly for long-acting injectables.

Keywords:
long acting injectablesmodel integrated evidencemodel master file

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Area of Science:

  • Regulatory Science
  • Pharmaceutical Sciences
  • Computational Modeling

Background:

  • The FDA and CRCG convened a workshop on Model Master Files (MMFs).
  • MMFs aim to standardize and share model-integrated evidence (MIE) in regulatory submissions.
  • Focus on applications for long-acting injectables (LAIs) and complex generics.

Purpose of the Study:

  • To summarize discussions on the potential regulatory applications of MMFs.
  • To explore MMF utility in LAI product development and regulatory submissions.
  • To identify challenges and considerations for MMF implementation.

Main Methods:

  • Summarized presentations from a public workshop (May 2-3, 2024).
  • Included insights from panel and small group discussions.
  • Reviewed case studies and potential MMF applications in LAI development.

Main Results:

  • MMFs can enhance model sharing, standardization, and regulatory efficiency.
  • Presentations covered MMF applications in PBPK, multiphysics, and popPK models.
  • The potential utility of a model-integrated bioequivalence (MI-BE) framework was discussed.

Conclusions:

  • MMFs offer significant anticipated benefits for model developers, industry, and regulators.
  • Implementation of MMFs for LAIs presents both opportunities and challenges.
  • MMFs are poised to streamline regulatory processes for complex pharmaceutical products.