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

Parenteral Drug Delivery Systems: Injectables, Implants, and Infusion Devices01:28

Parenteral Drug Delivery Systems: Injectables, Implants, and Infusion Devices

Parenteral drug delivery systems play a crucial role in modern therapeutics by enabling the direct administration of drugs into the systemic circulation, bypassing the gastrointestinal tract. These systems are particularly valuable for poorly absorbed oral medications that are unstable in the digestive environment or require rapid onset or sustained therapeutic levels. Delivery is achieved through intravenous, intramuscular, or subcutaneous routes, each selected based on the drug's properties...
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

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...

You might also read

Related Articles

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

Sort by
Same author

Overcoming device component-related challenges and risks in prefilled syringe development.

PDA journal of pharmaceutical science and technology·2026
Same author

Evaluating Nitrosamines from Elastomers in Pharmaceutical Primary Packaging.

PDA journal of pharmaceutical science and technology·2021
Same author

PARTICULATE MATTER FROM SYRINGES USED FOR INTRAVITREAL INJECTIONS.

Retina (Philadelphia, Pa.)·2020
Same author

Phase-Appropriate Application of Analytical Methods to Monitor Subvisible Particles Across the Biotherapeutic Drug Product Life Cycle.

The AAPS journal·2019
Same author

Linking hygroscopicity and the surface microstructure of model inorganic salts, simple and complex carbohydrates, and authentic sea spray aerosol particles.

Physical chemistry chemical physics : PCCP·2017
Same author

Optical and Physicochemical Properties of Brown Carbon Aerosol: Light Scattering, FTIR Extinction Spectroscopy, and Hygroscopic Growth.

The journal of physical chemistry. A·2016
Same journal

RETRACTED: Meligy et al. Therapeutic Potential of Mesenchymal Stem Cells Versus Omega n - 3 Polyunsaturated Fatty Acids on Gentamicin-Induced Cardiac Degeneration. <i>Pharmaceutics</i> 2022, <i>14</i>, 1322.

Pharmaceutics·2026
Same journal

Correction: Mohite et al. Bioactive Compound-Fortified Nanomedicine in the Modulation of Reactive Oxygen Species and Enhancement of the Wound Healing Process: A Review. <i>Pharmaceutics</i> 2025, <i>17</i>, 855.

Pharmaceutics·2026
Same journal

Metal Nanoparticle-Reinforced Hydrogels Applied in the Inhibition of Clinical Pathogens: Structural Features, Mechanisms, and Biomedical Prospects.

Pharmaceutics·2026
Same journal

Development and Evaluation of a Physiologically Based Pharmacokinetic Model for Cipepofol Across Diverse Clinical Populations.

Pharmaceutics·2026
Same journal

Artificial Intelligence in Nanopharmaceutical Development: From Predictive Design to Clinical Translation.

Pharmaceutics·2026
Same journal

Textilinin-1, a Snake Venom-Derived Kunitz-Type Protease Inhibitor, Accelerates Wound Healing Through Anti-Inflammatory, Antibacterial, and Pro-Regenerative Activities.

Pharmaceutics·2026
See all related articles

Related Experiment Video

Updated: May 28, 2026

Three-dimensional Printing of Thermoplastic Materials to Create Automated Syringe Pumps with Feedback Control for Microfluidic Applications
09:08

Three-dimensional Printing of Thermoplastic Materials to Create Automated Syringe Pumps with Feedback Control for Microfluidic Applications

Published on: August 30, 2018

Design Verification Testing for Prefilled Syringes: A Structured Best-Practice Framework.

Bettine Boltres1, Olga Laskina1, Brett Andrejko1

  • 1West Pharmaceutical Services, Stolberger Str. 21-41, 52249 Eschweiler, Germany.

Pharmaceutics
|May 27, 2026
PubMed
Summary
This summary is machine-generated.

This study presents a best-practice template for prefilled syringe (PFS) design verification (DV) planning. It offers a structured, risk-based approach to improve transparency and clarity for developers navigating complex regulatory and technical requirements.

Keywords:
EDDOscombination product developmentdesign verification testingprefilled syringesrisk-based developmentsample strategy

More Related Videos

The Quantification of Injectability by Mechanical Testing
04:46

The Quantification of Injectability by Mechanical Testing

Published on: May 13, 2020

Related Experiment Videos

Last Updated: May 28, 2026

Three-dimensional Printing of Thermoplastic Materials to Create Automated Syringe Pumps with Feedback Control for Microfluidic Applications
09:08

Three-dimensional Printing of Thermoplastic Materials to Create Automated Syringe Pumps with Feedback Control for Microfluidic Applications

Published on: August 30, 2018

The Quantification of Injectability by Mechanical Testing
04:46

The Quantification of Injectability by Mechanical Testing

Published on: May 13, 2020

Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Medical Device Development

Background:

  • Prefilled syringes (PFSs) are crucial for administering high-value parenteral drugs, but their design verification (DV) is complex.
  • Challenges arise from overlapping drug, device, and combination product requirements, and lack of component harmonization.
  • No comprehensive end-to-end DV approach for PFS development has been published.

Purpose of the Study:

  • To provide a best-practice template for structuring and justifying PFS design verification (DV) programs.
  • To enhance transparency and practical clarity for development teams facing regulatory and technical complexities.
  • To offer a transferable DV framework for prefilled syringes.

Main Methods:

  • A risk-based DV approach was applied to a 1 mL glass PFS for subcutaneous injection of a biologic surrogate.
  • Design inputs were derived from intended use, user needs, and the Quality Target Product Profile (QTPP).
  • Drug-independent and simulated drug-dependent tests, aligned with ISO and pharmacopeia standards, were performed.

Main Results:

  • A comprehensive best-practice DV approach for PFSs is presented.
  • Test results cover functional, mechanical, and integrity endpoints.
  • The approach links intended use to acceptance criteria, sample size rationale, and test selection.

Conclusions:

  • The presented DV approach offers a transferable template for PFS development.
  • It supports more consistent and defensible DV planning.
  • It aims to reduce ambiguity in drug and device development expectations for PFSs.