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 Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs

72
Body:Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
72
Drug Product Stability01:16

Drug Product Stability

79
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...
79
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

76
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...
76
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

61
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
61
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

82
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
82
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

266
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
266

You might also read

Related Articles

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

Sort by
Same author

International study of Coronary Microvascular Angina (iCorMicA): a registry-based diagnostic study and nested randomized trial.

American heart journal·2026
Same author

Comprehensive Evaluation of a Mucoadhesive Self-Emulsifying Anhydrous Base for Vaginal Drug Delivery.

Pharmaceuticals (Basel, Switzerland)·2026
Same author

Mastering particle size analysis: lessons, challenges, and future directions from the FDA-CRCG workshop.

AAPS open·2026
Same author

Experimental Investigation of Random Jamming Transition in Polydisperse Repulsive Nanoemulsions.

Langmuir : the ACS journal of surfaces and colloids·2026
Same author

Comparison of digital and optical microscopy for the evaluation of veterinary blood films: a preliminary study.

Journal of veterinary diagnostic investigation : official publication of the American Association of Veterinary Laboratory Diagnosticians, Inc·2026
Same author

Revisiting chlorophyll a thresholds for San Francisco Bay: insights from observations of phytoplankton molecular abundance.

Harmful algae·2026

Related Experiment Video

Updated: Nov 19, 2025

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
08:38

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS

Published on: November 8, 2015

17.2K

Beyond-use Date of Trimix: A Reproducible Stability Study Using Bracketing Design.

Gopesh Patel1, Countaney Davis2, Yi Liu3

  • 1VLS Pharmacy & New Drug Loft, Brooklyn, New York.

International Journal of Pharmaceutical Compounding
|January 27, 2021
PubMed
Summary

Reproducible stability testing confirms a 60-day beyond-use date for Trimix, a compounded erectile dysfunction treatment. This ensures reliable stability data for various Trimix strengths, enhancing patient care.

More Related Videos

Optimization of the Epimedii Folium Mutton-Oil Processing Technology and Testing Its Effect on Zebrafish Embryonic Development
06:00

Optimization of the Epimedii Folium Mutton-Oil Processing Technology and Testing Its Effect on Zebrafish Embryonic Development

Published on: March 17, 2023

678
Controlled-release of Chlorine Dioxide in a Perforated Packaging System to Extend the Storage Life and Improve the Safety of Grape Tomatoes
07:07

Controlled-release of Chlorine Dioxide in a Perforated Packaging System to Extend the Storage Life and Improve the Safety of Grape Tomatoes

Published on: April 7, 2017

11.3K

Related Experiment Videos

Last Updated: Nov 19, 2025

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
08:38

Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS

Published on: November 8, 2015

17.2K
Optimization of the Epimedii Folium Mutton-Oil Processing Technology and Testing Its Effect on Zebrafish Embryonic Development
06:00

Optimization of the Epimedii Folium Mutton-Oil Processing Technology and Testing Its Effect on Zebrafish Embryonic Development

Published on: March 17, 2023

678
Controlled-release of Chlorine Dioxide in a Perforated Packaging System to Extend the Storage Life and Improve the Safety of Grape Tomatoes
07:07

Controlled-release of Chlorine Dioxide in a Perforated Packaging System to Extend the Storage Life and Improve the Safety of Grape Tomatoes

Published on: April 7, 2017

11.3K

Area of Science:

  • Pharmaceutical Sciences
  • Compounded Medications
  • Stability Testing

Background:

  • Trimix is a vital compounded penile injection for erectile dysfunction (ED).
  • Alprostadil instability limits Trimix's shelf life and clinical utility.
  • Existing stability data requires further validation through reproducible studies.

Purpose of the Study:

  • To assess the reproducibility of a bracketing stability study for Trimix preparations.
  • To establish reliable beyond-use dates (BUDs) for a range of Trimix strengths.
  • To validate a bracketing approach for compounded medication stability.

Main Methods:

  • A validated stability-indicating method was employed.
  • Bracketing study design used for Trimix with varying strengths of alprostadil, papaverine, and phentolamine.
  • Compounding and storage were performed identically at two different practice settings.

Main Results:

  • Beyond-use dates of 60 and 64 days at cold temperatures were determined for Trimix preparations from two distinct settings.
  • Consistent results confirmed the reproducibility of the bracketing study design.
  • Stability data was generated for Trimix formulations ranging from 5 µg/mL to 45 µg/mL alprostadil.

Conclusions:

  • The bracketing approach is a reproducible method for determining Trimix BUDs.
  • This study provides accurate and broadly applicable stability data for Trimix.
  • Findings support the establishment of reliable BUDs for diverse Trimix formulations, improving ED treatment accessibility.