Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

Bioequivalence: Overview01:16

Bioequivalence: Overview

1.2K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.2K
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

192
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
192
Compartment Models: Single-Compartment Model01:14

Compartment Models: Single-Compartment Model

2.4K
The single-compartment model serves as a simplified representation of the human body. This model assumes that the body functions as a single, well-mixed open compartment. When a drug is administered intravenously, it enters the body and quickly distributes uniformly. The drug then undergoes biotransformation and elimination, ultimately leaving the body. The volume of this compartment is referred to as the apparent volume of distribution into which the drug can uniformly distribute. In this...
2.4K
Modeling and Similitude01:12

Modeling and Similitude

328
Scaled modeling is a fundamental technique in engineering, enabling the study of large and complex systems by creating smaller, manageable replicas that recreate critical characteristics of the original. In hydrology and civil infrastructure, for example, scaled models of dams help analyze water flow, turbulence, and pressure. This method allows for accurate predictions of real-world behavior within a controlled environment, significantly reducing the cost and time involved in full-scale...
328
Data Validation01:15

Data Validation

234
Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
234
Drug Regulation01:25

Drug Regulation

1.8K
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...
1.8K

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Evaluating Molecular Complexity with Open-Source Machine Learning Approaches to Predict Process Mass Intensity.

ACS omega·2024
Same author

Integrative Salt Selection and Formulation Optimization: Perspectives of Disproportionation and Microenvironmental pH Modulation.

Molecular pharmaceutics·2024
Same author

Hybrid heterogeneous phantoms for biomedical applications: a demonstration to dosimetry validation.

Biomedical optics express·2024
Same author

In silico screening of herbal phytochemicals to develop a Rasayana for immunity against Nipah virus.

Journal of Ayurveda and integrative medicine·2023
Same author

Developing In Situ Chemometric Models with Raman Spectroscopy for Monitoring an API Disproportionation with a Complex Polymorphic Landscape.

Pharmaceuticals (Basel, Switzerland)·2023
Same author

Exploring the pharmacological aspects of natural phytochemicals against SARS-CoV-2 Nsp14 through an in silico approach.

In silico pharmacology·2023
Same journal

Preventing tablet defects through vacuum-assisted deaeration of a powder bed.

International journal of pharmaceutics·2026
Same journal

Approaches for enhancing bioavailability of macromolecular drugs.

International journal of pharmaceutics·2026
Same journal

Characteristics of asymmetric microcrystalline solidification pellets and a better prediction for bioequiavailability based on solubility-permeability theory.

International journal of pharmaceutics·2026
Same journal

A CFPD-FSI analysis of the impact of nasal hairs on airflow patterns, nasal resistance, and particle filtration in a realistic human nasal airway.

International journal of pharmaceutics·2026
Same journal

Transient hydrate formation during disintegration of film-coated pharmaceutical tablets.

International journal of pharmaceutics·2026
Same journal

Use of a hydrophilic excipient to modulate the release of dapivirine, copper ions and zinc ions from a matrix-type vaginal ring.

International journal of pharmaceutics·2026
See all related articles

Related Experiment Video

Updated: Sep 9, 2025

A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM
13:54

A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM

Published on: August 18, 2023

4.9K

Simulation-based content uniformity engineering for drug development and manufacturing.

Kevin T Chu1, Remus Osan2, Nicole Tin2

  • 1Velexi Corporation, Burlingame, CA 94010, USA.

International Journal of Pharmaceutics
|September 3, 2025
PubMed
Summary
This summary is machine-generated.

Stochastic models and Monte Carlo simulations assess content uniformity (CU) risk. This study provides tools for process chemists to engineer particle size distributions (PSD) and manage CU risk in pharmaceutical manufacturing.

Keywords:
Content UniformityMonte Carlo SimulationParticle Size Distribution

More Related Videos

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
10:17

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

Published on: April 23, 2019

9.8K
Generation of 3D Tumor Spheroids for Drug Evaluation Studies
10:33

Generation of 3D Tumor Spheroids for Drug Evaluation Studies

Published on: February 24, 2023

2.3K

Related Experiment Videos

Last Updated: Sep 9, 2025

A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM
13:54

A Workflow for Lipid Nanoparticle LNP Formulation Optimization using Designed Mixture-Process Experiments and Self-Validated Ensemble Models SVEM

Published on: August 18, 2023

4.9K
High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry
10:17

High-throughput and Comprehensive Drug Surveillance Using Multisegment Injection-Capillary Electrophoresis-Mass Spectrometry

Published on: April 23, 2019

9.8K
Generation of 3D Tumor Spheroids for Drug Evaluation Studies
10:33

Generation of 3D Tumor Spheroids for Drug Evaluation Studies

Published on: February 24, 2023

2.3K

Area of Science:

  • Pharmaceutical Sciences
  • Computational Chemistry
  • Process Engineering

Background:

  • Stochastic models and Monte Carlo (MC) simulations are crucial for evaluating content uniformity (CU) risk in pharmaceutical manufacturing, reducing the need for extensive experimentation.
  • The accuracy and appropriate application of these simulations are paramount for their utility within operational workflows.

Purpose of the Study:

  • To analyze a stochastic model of tablet formation for quantitative characterizations of dose regimes based on active pharmaceutical ingredient (API) particle size distribution (PSD), offering early CU risk guidance.
  • To validate the significance of upper particle size cutoff diameters in MC simulations, considering manufacturing processes and safety margins.
  • To demonstrate simulation-based tools for PSD engineering and CU risk assessment, integrating into common pharmaceutical development workflows.

Main Methods:

  • Analysis of a stochastic tablet formation model to derive quantitative dose regime characterizations linked to API PSD.
  • Monte Carlo (MC) simulation of the stochastic tablet formation model to assess the impact of particle size cutoffs.
  • Development of simulation-based tools for process chemists and formulators for PSD engineering and CU risk assessment.

Main Results:

  • Quantitative characterizations of dose regimes based on API PSD were developed, providing early CU risk indicators.
  • The importance of selecting appropriate upper particle size cutoff diameters in MC simulations, incorporating manufacturing process considerations and safety margins, was validated.
  • Simulation-based tools were demonstrated for early-stage PSD target guidance, prediction of United States Pharmacopeia (USP) <905> pass rates, and identification of low-risk API PSD parameters and dose strengths.

Conclusions:

  • Stochastic modeling and MC simulations offer powerful, validated tools for assessing and managing CU risk in pharmaceutical development.
  • Simulation-based approaches enable proactive PSD engineering and risk assessment, optimizing pharmaceutical manufacturing processes.
  • The developed tools facilitate informed decision-making for process chemists and formulators, enhancing the efficiency and reliability of drug product development.