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

Drug Product Stability01:16

Drug Product Stability

303
The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...
303
In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

386
Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
386
In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

353
Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
353
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

221
Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
221
Sample Handling01:02

Sample Handling

2.8K
Transportation of samples from the collection point to the laboratory, as well as storage and preservation techniques, are crucial for maintaining sample integrity and ensuring accurate and reliable test results.
Samples should be transported carefully from collection points to the laboratory. They should be properly sealed and clearly labeled to prevent cross-contamination. To preserve the sample integrity, optimal temperature conditions during transport are essential. This could involve using...
2.8K

You might also read

Related Articles

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

Sort by
Same author

Renal Point-of-Care Ultrasound Findings and Downstream Computed Tomography Use, Urologic Intervention, and Emergency Department Length of Stay in Renal Colic.

The Journal of emergency medicine·2026
Same author

Response to Letter to editor Regarding "Low incidence of acute actionable imaging findings in emergency department patients imaged for vertigo".

Emergency radiology·2026
Same author

Pharmacokinetics of Asciminib 200 mg in the Presence of a Strong CYP3A4 Inducer, Phenytoin, in Healthy Participants.

Clinical pharmacokinetics·2026
Same author

Publishing sleep and chronobiology research without barriers.

Npj biological timing and sleep·2026
Same author

Helicopter Emergency Medical Services attendance is associated with favourable survival outcomes in major trauma: derivation and internal validation of prediction models in a regional trauma system.

Emergency medicine journal : EMJ·2026
Same author

Low incidence of acute actionable imaging findings in emergency department patients imaged for vertigo: Retrospective analysis and proposed guidelines.

Emergency radiology·2025
Same journal

Enhanced Stability and Transdermal Delivery of Semaglutide Using an L-Arginine Based Dissolving Microneedle System.

AAPS PharmSciTech·2026
Same journal

The Preparation and Physicochemical Characterization of a Triple Synergistic Nanoplatform Designed for Targeted Subcutaneous Delivery of Sitagliptin with Potential for β-Cell Preservation.

AAPS PharmSciTech·2026
Same journal

Repurposing Non-oncologic Drugs via Targeted Nanocarriers for Cancer Therapy: Mechanisms, Synergistic Combinations, and Clinical Translation.

AAPS PharmSciTech·2026
Same journal

Targeting Permeability Barriers By Strategic Selection of Thiol Containing Coformer for Novel Cocrystals of Metformin.

AAPS PharmSciTech·2026
Same journal

Plume Geometry Matters: Investigating the Contribution of Mass-Based Plume Geometry to Aerosol Delivery Efficiency in pMDIs.

AAPS PharmSciTech·2026
Same journal

Eigenrate-Based Thermodynamic Decomposition of Competing Release Mechanisms in Polymeric Nano- and Microspheres: The MMIR-S Framework with Arrhenius Dual-Population Burst Kinetics and Log-Normal Polydispersity Averaging.

AAPS PharmSciTech·2026
See all related articles

Related Experiment Video

Updated: Feb 22, 2026

Quantifying Yeast Chronological Life Span by Outgrowth of Aged Cells
12:24

Quantifying Yeast Chronological Life Span by Outgrowth of Aged Cells

Published on: May 6, 2009

17.4K

Evaluating Current Practices in Shelf Life Estimation.

Robert Capen1,2, David Christopher3, Patrick Forenzo4

  • 1CMC Statistics, Merck, West Point, Pennsylvania, USA. robert_capen@merck.com.

AAPS Pharmscitech
|September 27, 2017
PubMed
Summary
This summary is machine-generated.

Current International Council for Harmonisation (ICH) methods for drug shelf life determination do not effectively manage risk. Analysis of industry data indicates that ICH approaches may lead to too many nonconforming batches or premature discarding of safe products, necessitating alternative methods.

Keywords:
FDAICH Q1A/Q1Emanaging riskshelf life estimationstability

More Related Videos

Measurement of Protein Turnover Rates in Senescent and Non-Dividing Cultured Cells with Metabolic Labeling and Mass Spectrometry
08:52

Measurement of Protein Turnover Rates in Senescent and Non-Dividing Cultured Cells with Metabolic Labeling and Mass Spectrometry

Published on: April 6, 2022

4.1K
Using Multiple Light Scattering to Examine the Stability of Phyllanthus emblica L. Extracts Obtained with Different Extraction Methods
06:12

Using Multiple Light Scattering to Examine the Stability of Phyllanthus emblica L. Extracts Obtained with Different Extraction Methods

Published on: April 14, 2023

1.0K

Related Experiment Videos

Last Updated: Feb 22, 2026

Quantifying Yeast Chronological Life Span by Outgrowth of Aged Cells
12:24

Quantifying Yeast Chronological Life Span by Outgrowth of Aged Cells

Published on: May 6, 2009

17.4K
Measurement of Protein Turnover Rates in Senescent and Non-Dividing Cultured Cells with Metabolic Labeling and Mass Spectrometry
08:52

Measurement of Protein Turnover Rates in Senescent and Non-Dividing Cultured Cells with Metabolic Labeling and Mass Spectrometry

Published on: April 6, 2022

4.1K
Using Multiple Light Scattering to Examine the Stability of Phyllanthus emblica L. Extracts Obtained with Different Extraction Methods
06:12

Using Multiple Light Scattering to Examine the Stability of Phyllanthus emblica L. Extracts Obtained with Different Extraction Methods

Published on: April 14, 2023

1.0K

Area of Science:

  • Pharmaceutical Sciences
  • Drug Stability
  • Regulatory Science

Background:

  • Current drug shelf life determination relies on International Council for Harmonisation (ICH) guidance documents Q1A and Q1E.
  • Assessing the adequacy of these ICH methods is crucial for ensuring drug product quality and safety throughout its lifecycle.

Purpose of the Study:

  • To evaluate the effectiveness of current ICH methods for determining supported drug product shelf life.
  • To assess the risk management capabilities of ICH shelf life determination approaches.
  • To identify potential limitations and propose alternative strategies for shelf life assessment.

Main Methods:

  • Utilized an industry dataset comprising 26 stability batches of a common drug product, with measurements over a 24-month storage period.
  • Randomly sampled sets of 3 or 6 batches to assess ICH methods from multiple perspectives.
  • Compared distributional properties of supported vs. true shelf lives and evaluated ICH 'poolability' tests for model selection.

Main Results:

  • The ICH-recommended approach for shelf life determination did not effectively manage risks associated with drug product expiry.
  • Shelf life estimates that were too long resulted in an unacceptable percentage of nonconforming batches.
  • Estimates that were too short posed a risk of premature discarding of safe and efficacious drug products.

Conclusions:

  • The current ICH methods for determining supported shelf life require re-evaluation due to inadequate risk management.
  • Alternative approaches are necessary to ensure accurate and reliable shelf life estimations for pharmaceutical products.
  • Optimizing shelf life determination is critical for both patient safety and pharmaceutical industry efficiency.