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

Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

286
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
286
Drug Product Stability01:16

Drug Product Stability

358
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...
358
Sample Handling01:02

Sample Handling

3.2K
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...
3.2K
Quality Control01:05

Quality Control

4.3K
Quality control is one of the three cyclical quality assurance activities that help keep a system under statistical control. Typical quality control activities include creating quality control charts, conducting proficiency testing, and documenting and archiving results.
Quality control helps track data, visualize trends, and identify variations, making it easier to detect deviations that may affect the accuracy of an analysis. One way to do this is by generating a quality control chart, which...
4.3K
Introduction to Statistical Process Control01:15

Introduction to Statistical Process Control

848
Statistical Process Control (SPC) is a method used to monitor and control quality within processes, particularly in manufacturing and service delivery, by employing statistical methods. SPC aims to distinguish between natural (common cause) variation and variation due to specific changes or events (special cause), allowing for timely improvements and sustained quality. The control chart, a pivotal tool in SPC, visually displays data over time alongside a central line of upper and lower control...
848
Standard Precaution01:26

Standard Precaution

3.6K
Standard precautions are the minimum infection control safeguards used while caring for all patients, irrespective of their disease condition. They help prevent the spread of common infectious microorganisms to healthcare workers, patients, and visitors in all healthcare settings.
Hand hygiene is the most crucial means to prevent the transmission of disease. Employers are legally required to provide their workers with personal protective equipment (PPE) to minimize exposure or contact with...
3.6K

You might also read

Related Articles

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

Sort by
Same author

Vaccine Ligand Binding Assay Life Cycle Management, Assay Maintenance, Monitoring and Transfer.

Bioanalysis·2026
Same author

Plasma and intrapulmonary pharmacokinetics of funobactam, a novel diazabicyclooctane β-lactamase inhibitor, administered in combination with imipenem/cilastatin in healthy subjects.

Antimicrobial agents and chemotherapy·2026
Same author

Development of a Rapid, High-Resolution Microbial Identification Platform: Poster Presented at PDA Microbiology Conference 2025.

PDA journal of pharmaceutical science and technology·2026
Same author

Peri-operative management of diabetes mellitus: a multidisciplinary consensus statement from the Association of Anaesthetists and the Joint British Diabetes Societies for Inpatient Care group.

Anaesthesia·2026
Same author

2025 White Paper on Recent Issues in Bioanalysis: What is the Future of Bioanalytical LIMS? AI/ML Integration in Bioanalysis; Tear Sample Collection; Radiolabeled Mass Balance Studies; Chiral Assays; Bioanalysis of Antibody-Oligonucleotide & Bicycle Drug Conjugates (<u>PART 1A</u> - Recommendations on Mass Spectrometry Assays, Chromatography, Sample Preparation and Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting <u>PART 1B</u> - Regulatory Agencies' Input on Regulated Bioanalysis/BMV).

Bioanalysis·2026
Same author

2025 White Paper on Recent Issues in Bioanalysis: Biomarkers Calibrators & Stability; Evaluation of NULISA; Neurofilament & Autoantibody Biomarker Assays; Removing IgM Interference; ELISpot & FluoroSpot Best Practices; Modular HD Cytometry; Single-cell Analysis Imaging Cytometry (PART 2A - Recommendations on Biomarkers Discovery, Development, Validation & Regulatory Approval, Ligand-Binding Assays (LBA) and Cell-Based Assays (CBA) PART 2B - Regulatory Agencies' Input on Biomarkers, IVD/CDx and Biomarker Assay Validation (BAV)).

Bioanalysis·2026
Same journal

A simple, sensitive microsample LC-MS assay for quercetin and isorhamnetin in mouse and human plasma: application to EMIQ treatment in myotonic dystrophy type 1.

Bioanalysis·2026
Same journal

ADA assays for high-dose biologics: redefining drug tolerance through clinical insights.

Bioanalysis·2026
Same journal

Comparison of SERS spectral data sets of blood serum samples of hypopharyngeal cancer using silver and gold nanoparticles as substrates.

Bioanalysis·2026
Same journal

The Gyrolab platform for immunogenicity assessment and biotherapeutic and biomarker analysis: technical advances and bioanalytical applications.

Bioanalysis·2026
Same journal

Simultaneous quantification of D-penicillamine, D-penicillamine disulfide, and L-cysteine-D-penicillamine disulfide in human plasma: optimization of sample preparation and mass spectrometry procedures to support bioequivalence studies.

Bioanalysis·2026
Same journal

Development and preliminary clinical application of a time-resolved fluoroimmunoassay for anti-rituximab antibodies in membranous nephropathy.

Bioanalysis·2026
See all related articles

Related Experiment Video

Updated: Apr 21, 2026

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

4.8K

Recommendations on incurred sample stability (ISS) by GCC.

Steve Lowes1, Richard LeLacheur, Ronald Shoup

  • 1Quintiles Bioanalytical & ADME Labs, Ithaca, NY, USA.

Bioanalysis
|November 12, 2014
PubMed
Summary
This summary is machine-generated.

Incurred sample stability (ISS) is crucial for bioanalytical methods. This paper details discussions and recommendations on using incurred samples for ISS, based on a Global CRO Council for Bioanalysis survey.

More Related Videos

Measurement of Cyclic Guanosine Monophosphate (cGMP) in Solid Tissues using Competitive Enzyme-Linked Immunosorbent Assay (ELISA)
07:15

Measurement of Cyclic Guanosine Monophosphate (cGMP) in Solid Tissues using Competitive Enzyme-Linked Immunosorbent Assay (ELISA)

Published on: July 3, 2025

891
Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
07:00

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface

Published on: August 11, 2017

8.8K

Related Experiment Videos

Last Updated: Apr 21, 2026

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies
09:30

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

4.8K
Measurement of Cyclic Guanosine Monophosphate (cGMP) in Solid Tissues using Competitive Enzyme-Linked Immunosorbent Assay (ELISA)
07:15

Measurement of Cyclic Guanosine Monophosphate (cGMP) in Solid Tissues using Competitive Enzyme-Linked Immunosorbent Assay (ELISA)

Published on: July 3, 2025

891
Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
07:00

Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface

Published on: August 11, 2017

8.8K

Area of Science:

  • Bioanalytical Chemistry
  • Pharmaceutical Analysis

Background:

  • Incurred sample stability (ISS) has become a significant topic in bioanalytical discussions.
  • Recent workshops and meetings, including the Workshop on Recent Issues in Bioanalysis (WRIB) and the Global CRO Council for Bioanalysis (GCC), have highlighted ISS.

Purpose of the Study:

  • To report the consensus reached on incurred sample stability (ISS) issues.
  • To summarize results from a GCC survey on the use of incurred samples for ISS.
  • To provide recommendations for ISS in bioanalytical method development and application.

Main Methods:

  • Discussions at WRIB and GCC meetings.
  • Analysis of results from a GCC member company survey on ISS.

Main Results:

  • The paper consolidates discussions and survey findings regarding ISS.
  • Identifies key issues and concerns related to incurred sample stability testing.

Conclusions:

  • Provides a consensus view on incurred sample stability (ISS).
  • Offers practical recommendations for bioanalytical laboratories on implementing ISS.
  • Serves as a reference for addressing challenges in incurred sample stability.