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

Pharmacovigilance01:19

Pharmacovigilance

1.6K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.6K
Structure-Activity Relationships and Drug Design01:28

Structure-Activity Relationships and Drug Design

1.7K
Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
SAR studies the intricate relationship between a drug's chemical structure and biological activity. It focuses on understanding how modifications to a drug's structure can influence...
1.7K
Global Regulatory Systems01:28

Global Regulatory Systems

613
Global regulatory systems in bacteria enable rapid and coordinated responses to environmental changes by integrating sensory inputs with gene expression, ensuring efficient adaptation to fluctuating conditions. Key global regulatory mechanisms include regulons, two-component systems, sigma factors, and secondary messengers.Regulons and Global RegulatorsA regulon is a collection of genes and operons controlled by a common global regulator. These regulators enable bacteria to prioritize resource...
613
Drug Regulation01:25

Drug Regulation

2.7K
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...
2.7K
In Vitro Drug Release Testing: Overview, Development and Validation01:10

In Vitro Drug Release Testing: Overview, Development and Validation

312
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...
312

You might also read

Related Articles

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

Sort by
Same author

Nebulised heparin as a treatment for lung diseases: formulation challenges and pulmonary drug delivery strategies.

Lung·2026
Same author

Microneedle technologies in emerging strategies for non-transdermal drug delivery.

International journal of pharmaceutics·2026
Same author

Nanorobotics at a crossroads: an overview of design, propulsion, and applications.

International journal of pharmaceutics·2026
Same author

Integrating artificial intelligence into drug delivery systems: Formulation development and current challenges.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V·2026
Same author

Crescentic Glomerulonephritis in a Patient With AL Amyloidosis: A Case Report.

Kidney medicine·2026
Same author

Targeting the brain: alternative administration routes and drug delivery systems for antidepressant therapy.

Expert opinion on drug delivery·2026
Same journal

A "three-in-one" nose-to-brain delivery strategy: intranasal vancomycin spray achieves simultaneous clearance of pneumococcal colonization, bacteremia, and meningitis.

International journal of pharmaceutics·2026
Same journal

10-Hydroxy-2-decenoic acid /matrine deep eutectic solvent encapsulated in hyalurosomes for enhanced transdermal delivery and antioxidant efficacy.

International journal of pharmaceutics·2026
Same journal

Dual-trigger hyaluronic acid nanoprodrug incorporating a 2-nitrobenzenesulfonyl linker for CD44-targeted and glutathione-responsive drug delivery.

International journal of pharmaceutics·2026
Same journal

Polymeric mixed micellar nanogel enhances dermal delivery and therapeutic efficacy of tofacitinib citrate.

International journal of pharmaceutics·2026
Same journal

Localized gold nanoparticles-mediated photothermal therapy for head and neck cancer: in vivo proof-of-concept.

International journal of pharmaceutics·2026
Same journal

Design and evaluation of a pump-free ultrasonic atomization-driven hollow microneedle array for transdermal drug delivery.

International journal of pharmaceutics·2026
See all related articles

Related Experiment Video

Updated: Jan 19, 2026

Reduced Procedure Time and Variability with Active Esophageal Cooling During Radiofrequency Ablation for Atrial Fibrillation
04:58

Reduced Procedure Time and Variability with Active Esophageal Cooling During Radiofrequency Ablation for Atrial Fibrillation

Published on: August 25, 2022

2.5K

aQbD as a platform for IVRT method development - A regulatory oriented approach.

Margarida Miranda1, Alberto A C C Pais2, Catarina Cardoso3

  • 1Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal; Coimbra Chemistry Center, Department of Chemistry, University of Coimbra, Rua Larga, 3004-535 Coimbra, Portugal.

International Journal of Pharmaceutics
|September 20, 2019
PubMed
Summary
This summary is machine-generated.

A new analytical quality by design (aQbD) framework establishes a discriminatory in vitro release testing (IVRT) method for topical products. This method, validated per EMA guidelines, ensures quality and equivalence for regulatory submissions.

Keywords:
Analytical quality by designEMA guidelineIVRTTopical generic products

More Related Videos

Author Spotlight: Automated Deep Brain Stimulation for Parkinson's Disease - Exploring the Possibilities and Challenges of Home Monitoring
06:32

Author Spotlight: Automated Deep Brain Stimulation for Parkinson's Disease - Exploring the Possibilities and Challenges of Home Monitoring

Published on: July 14, 2023

1.8K
Development of an Algorithm to Perform a Comprehensive Study of Autonomic Dysreflexia in Animals with High Spinal Cord Injury Using a Telemetry Device
06:51

Development of an Algorithm to Perform a Comprehensive Study of Autonomic Dysreflexia in Animals with High Spinal Cord Injury Using a Telemetry Device

Published on: July 29, 2016

8.3K

Related Experiment Videos

Last Updated: Jan 19, 2026

Reduced Procedure Time and Variability with Active Esophageal Cooling During Radiofrequency Ablation for Atrial Fibrillation
04:58

Reduced Procedure Time and Variability with Active Esophageal Cooling During Radiofrequency Ablation for Atrial Fibrillation

Published on: August 25, 2022

2.5K
Author Spotlight: Automated Deep Brain Stimulation for Parkinson's Disease - Exploring the Possibilities and Challenges of Home Monitoring
06:32

Author Spotlight: Automated Deep Brain Stimulation for Parkinson's Disease - Exploring the Possibilities and Challenges of Home Monitoring

Published on: July 14, 2023

1.8K
Development of an Algorithm to Perform a Comprehensive Study of Autonomic Dysreflexia in Animals with High Spinal Cord Injury Using a Telemetry Device
06:51

Development of an Algorithm to Perform a Comprehensive Study of Autonomic Dysreflexia in Animals with High Spinal Cord Injury Using a Telemetry Device

Published on: July 29, 2016

8.3K

Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Regulatory Science

Background:

  • Recent EMA and FDA guidances highlight the need for robust in vitro release testing (IVRT) for topical products.
  • Establishing a regulatory framework for IVRT is crucial for ensuring product quality and equivalence.

Purpose of the Study:

  • To describe a novel framework for developing a discriminatory IVRT method using analytical quality by design (aQbD) principles.
  • To apply this framework to a diclofenac emulgel formulation and validate the method according to current EMA requirements.

Main Methods:

  • Utilized analytical quality by design (aQbD) principles for method development.
  • Conducted a risk assessment to identify critical analytical attributes and method variables.
  • Employed a 3x2x3 full factorial design, statistical modeling, and system desirability for parameter optimization.
  • Validated the selected IVRT parameters against EMA guidelines.

Main Results:

  • Identified critical parameters including medium composition (PBS:Ethanol 80:20, pH 7.4), Tuffryn membranes, and applied product amount (300 mg).
  • Successfully developed and validated a discriminatory IVRT method for the model topical product.
  • Statistical modeling and desirability assessment effectively guided the selection of optimal IVRT conditions.

Conclusions:

  • The aQbD approach provides a comprehensive framework for developing reliable and effective IVRT methods for topical products.
  • The developed IVRT method meets the requirements of the new EMA draft guideline.
  • Achieving all criteria within the new EMA draft guideline may present challenges.