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

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

257
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
257
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

201
As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
201
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

192
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...
192
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

499
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
499
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

182
Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
182
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

161
Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
161

You might also read

Related Articles

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

Sort by
Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2019
Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2019
Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2019
Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2019
Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2018
Same author

Pharmaceutical Approval Update.

P & T : a peer-reviewed journal for formulary management·2018
Same journal

Formulary Substitution of Proton Pump Inhibitors Based on Acquisition Price: Changes in Usage and Costs of Acid-Suppressant Therapies.

P & T : a peer-reviewed journal for formulary management·2021
Same journal

Is Ciprofloxacin in Combination With Beta-lactam Antibiotics a Recipe for Thrombocytosis?: A Case Report of Thrombocytosis in a Patient Receiving Ciprofloxacin and Ceftriaxone.

P & T : a peer-reviewed journal for formulary management·2021
Same journal

Looking for Trouble: Identifying and Treating Hypotension.

P & T : a peer-reviewed journal for formulary management·2019
Same journal

Research Briefs.

P & T : a peer-reviewed journal for formulary management·2019
Same journal

The Impact of Self-Monitoring Blood Glucose Adherence On Glycemic Goal Attainment in an Indigent Population, With Pharmacy Assistance.

P & T : a peer-reviewed journal for formulary management·2019
Same journal

Continuous Glucose Monitoring: A Review of Available Systems.

P & T : a peer-reviewed journal for formulary management·2019
See all related articles

Related Experiment Video

Updated: Jan 29, 2026

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

8.6K

Pharmaceutical Approval Update.

Michele B Kaufman

    P & T : a Peer-Reviewed Journal for Formulary Management
    |February 16, 2019
    PubMed
    Summary
    This summary is machine-generated.

    New treatments for lung infections, influenza, and bacterial pneumonia are reviewed. These include amikacin liposome inhalation suspension, baloxavir marboxil, and omadacycline for specific bacterial and viral infections.

    More Related Videos

    Coherent anti-Stokes Raman Scattering CARS Microscopy Visualizes Pharmaceutical Tablets During Dissolution
    09:59

    Coherent anti-Stokes Raman Scattering CARS Microscopy Visualizes Pharmaceutical Tablets During Dissolution

    Published on: July 4, 2014

    18.6K
    Toxicity Screens in Human Retinal Organoids for Pharmaceutical Discovery
    07:45

    Toxicity Screens in Human Retinal Organoids for Pharmaceutical Discovery

    Published on: March 4, 2021

    3.9K

    Related Experiment Videos

    Last Updated: Jan 29, 2026

    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

    8.6K
    Coherent anti-Stokes Raman Scattering CARS Microscopy Visualizes Pharmaceutical Tablets During Dissolution
    09:59

    Coherent anti-Stokes Raman Scattering CARS Microscopy Visualizes Pharmaceutical Tablets During Dissolution

    Published on: July 4, 2014

    18.6K
    Toxicity Screens in Human Retinal Organoids for Pharmaceutical Discovery
    07:45

    Toxicity Screens in Human Retinal Organoids for Pharmaceutical Discovery

    Published on: March 4, 2021

    3.9K

    Area of Science:

    • Infectious Diseases
    • Pharmacology
    • Respiratory Medicine

    Background:

    • Rising incidence of antibiotic-resistant bacteria and viral infections necessitates novel therapeutic strategies.
    • Mycobacterium avium complex (MAC) lung disease, influenza, and community-acquired bacterial pneumonia (CABP) pose significant public health challenges.
    • Existing treatments may have limitations in efficacy, safety, or resistance development.

    Purpose of the Study:

    • To review the clinical applications and efficacy of three recently approved or investigated medications.
    • To provide an overview of Arikayce (amikacin liposome inhalation suspension), Xofluza (baloxavir marboxil), and Nuzyra (omadacycline).
    • To highlight their roles in treating specific infectious diseases.

    Main Methods:

    • Literature review of clinical trials and post-marketing data.
    • Analysis of pharmacokinetic and pharmacodynamic properties.
    • Evaluation of safety and tolerability profiles.

    Main Results:

    • Arikayce demonstrated efficacy in patients with MAC lung disease, particularly in those with limited treatment options.
    • Xofluza showed effectiveness in reducing influenza symptom duration and viral shedding.
    • Nuzyra provided a novel treatment option for CABP and acute bacterial skin and skin structure infections (ABSSSI).

    Conclusions:

    • These agents represent important advancements in managing challenging infectious diseases.
    • Optimized use of these medications can improve patient outcomes and address unmet needs.
    • Continued research and surveillance are crucial for monitoring resistance and long-term effectiveness.