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

279
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,...
279
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

208
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.
208
Pharmaceutical Poisoning: Potential Scenarios01:26

Pharmaceutical Poisoning: Potential Scenarios

15
Pharmaceutical poisoning can occur through various channels, impacting an estimated 2 million hospitalized patients in the U.S. annually with serious adverse drug responses. These scenarios encompass both therapeutic uses, such as drug toxicity, where even standard dosages can lead to severe central nervous system depression, and non-therapeutic exposures, including accidental ingestion by children, and environmental and occupational exposures.Unintentional poisonings often involve exploratory...
15
Pharmaceutical Poisoning: Treatment Strategies01:26

Pharmaceutical Poisoning: Treatment Strategies

16
Treatment strategies for poisoning are a critical aspect of emergency medicine, focusing on preventing the absorption of toxins and enhancing their elimination. When a poisoning incident occurs, the first response is to halt exposure and decontaminate the patient, particularly through gastrointestinal (GI) methods if the poison was ingested.Gastrointestinal Decontamination Techniques:Activated charcoal is the cornerstone of GI decontamination. It works through adsorption, binding the toxin to...
16
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

214
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...
214
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

189
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...
189

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·2019
Same author

Pharmaceutical Approval Update.

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

Related Experiment Video

Updated: Feb 15, 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

8.7K

Pharmaceutical Approval Update.

Michele B Kaufman

    P & T : a Peer-Reviewed Journal for Formulary Management
    |February 2, 2018
    PubMed
    Summary
    This summary is machine-generated.

    New treatments offer hope for rare diseases. Benznidazole is approved for pediatric Chagas disease, Mepsevii for mucopolysaccharidosis type VII, and Heplisav-B for hepatitis B prevention in adults.

    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
    The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
    06:05

    The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

    Published on: February 19, 2021

    1.8K

    Related Experiment Videos

    Last Updated: Feb 15, 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

    8.7K
    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
    The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
    06:05

    The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time

    Published on: February 19, 2021

    1.8K

    Area of Science:

    • Medical Science
    • Pharmacology
    • Immunology

    Background:

    • Chagas disease, mucopolysaccharidosis type VII, and hepatitis B virus infections represent significant unmet medical needs.
    • Existing treatment options for these conditions are limited or unavailable for certain patient populations.
    • Advancements in drug development and vaccine technology are crucial for addressing these health challenges.

    Purpose of the Study:

    • To evaluate the efficacy and safety of benznidazole in pediatric patients diagnosed with Chagas disease.
    • To assess the therapeutic potential of vestronidase alfa-vjbk (Mepsevii) in adult and pediatric individuals with mucopolysaccharidosis type VII.
    • To determine the effectiveness of the adjuvanted recombinant hepatitis B vaccine (Heplisav-B) in preventing hepatitis B virus infection across all subtypes in adults.

    Main Methods:

    • Clinical trials were conducted to assess benznidazole's impact on Chagas disease in pediatric cohorts.
    • Patient outcomes and safety profiles were monitored in individuals receiving vestronidase alfa-vjbk for mucopolysaccharidosis type VII.
    • Immunogenicity and safety studies were performed for the adjuvanted recombinant hepatitis B vaccine in adult populations.

    Main Results:

    • Benznidazole demonstrated efficacy in treating pediatric Chagas disease.
    • Vestronidase alfa-vjbk showed a positive therapeutic effect in patients with mucopolysaccharidosis type VII.
    • Heplisav-B proved effective in preventing hepatitis B virus infection in adults, covering all known subtypes.

    Conclusions:

    • Benznidazole provides a new therapeutic option for pediatric Chagas disease.
    • Vestronidase alfa-vjbk expands treatment possibilities for mucopolysaccharidosis type VII.
    • The adjuvanted recombinant hepatitis B vaccine offers robust protection against hepatitis B virus for adults.