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

Drugs for Treatment of Constipation-Predominant IBS01:21

Drugs for Treatment of Constipation-Predominant IBS

548
Pharmacological therapies for IBS-C are designed to alleviate abdominal discomfort and enhance bowel function. In patients with IBS-C, fiber supplements may help soften stools and decrease straining, but may also lead to increased gas production and bloating. Osmotic laxatives like milk of magnesia are frequently used to soften stools and increase stool frequency in IBS-C patients. In addition, two drugs approved for use in severe IBS-C adult cases are linaclotide (Linzess) and lubiprostone...
548
Drugs for Treatment of Diarrhea-Predominant IBS01:17

Drugs for Treatment of Diarrhea-Predominant IBS

479
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a subtype of IBS characterized primarily by frequent, loose, or watery stools, abdominal pain, and abdominal discomfort. Therapeutic approaches to managing IBS-D include dietary changes, stress management techniques, and pharmaceutical interventions.
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
479
FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

106
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,...
106
Drugs for Treatment of Ulcerative Colitis in IBD01:29

Drugs for Treatment of Ulcerative Colitis in IBD

335
Ulcerative colitis is a chronic inflammatory condition primarily affecting the colon and rectum. The primary drugs used in the treatment of ulcerative colitis are aminosalicylates. They exhibit anti-inflammatory and immunosuppressive properties. They modulate inflammatory mediators and inhibit the activity of nuclear factor κB (NF-κB). Aminosalicylates also reduce inflammation by inhibiting prostaglandin and leukotriene production and decreasing neutrophil chemotaxis and superoxide...
335
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

145
Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
145
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

107
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
107

You might also read

Related Articles

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

Sort by
Same author

Leniolisib: First Approval.

Drugs·2023
Same author

Correction to: Durvalumab: A Review in Extensive-Stage SCLC.

Targeted oncology·2021
Same author

Durvalumab: A Review in Extensive-Stage SCLC.

Targeted oncology·2021
Same author

Encorafenib: A Review in Metastatic Colorectal Cancer with a BRAF V600E Mutation.

Drugs·2021
Same author

Mecapegfilgrastim in Chemotherapy-Induced Neutropenia: A Profile of Its Use in China.

Clinical drug investigation·2019
Same author

Apalutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer.

Drugs·2019
Same journal

Botulinum Toxin Type A for Trigeminal and Postherpetic Neuralgia: An Umbrella Review of Systematic Reviews.

Drugs·2026
Same journal

Biologics and Small Molecule Inhibitors: Novel Therapeutic Strategies for Cutaneous Adverse Drug Reactions.

Drugs·2026
Same journal

Use of Sedative-Hypnotic Drugs and the Risk of Developing Alzheimer's Disease: A Systematic Review, Meta-Analysis and Meta-Regression.

Drugs·2026
Same journal

Relacorilant: First Approval.

Drugs·2026
Same journal

Developmental Progress and Future Potential for Inhaled Biologics in the Treatment of Respiratory Diseases.

Drugs·2026
Same journal

Linerixibat: First Approval.

Drugs·2026
See all related articles

Related Experiment Video

Updated: Dec 5, 2025

Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients
06:14

Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients

Published on: October 15, 2017

8.6K

Imlifidase: First Approval.

Zaina T Al-Salama1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|October 15, 2020
PubMed
Summary
This summary is machine-generated.

Imlifidase, an IgG-degrading enzyme, is approved in the EU for kidney transplant desensitization in highly sensitized patients. This milestone enables treatment for patients with positive crossmatches, improving transplant accessibility.

More Related Videos

Rapid Depletion of Renal Macrophages Using Human CD59/Intermedilysin Cell Ablation Tool
10:15

Rapid Depletion of Renal Macrophages Using Human CD59/Intermedilysin Cell Ablation Tool

Published on: May 9, 2025

544
In Vivo Immunofluorescence Localization for Assessment of Therapeutic and Diagnostic Antibody Biodistribution in Cancer Research
08:53

In Vivo Immunofluorescence Localization for Assessment of Therapeutic and Diagnostic Antibody Biodistribution in Cancer Research

Published on: September 16, 2019

9.4K

Related Experiment Videos

Last Updated: Dec 5, 2025

Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients
06:14

Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients

Published on: October 15, 2017

8.6K
Rapid Depletion of Renal Macrophages Using Human CD59/Intermedilysin Cell Ablation Tool
10:15

Rapid Depletion of Renal Macrophages Using Human CD59/Intermedilysin Cell Ablation Tool

Published on: May 9, 2025

544
In Vivo Immunofluorescence Localization for Assessment of Therapeutic and Diagnostic Antibody Biodistribution in Cancer Research
08:53

In Vivo Immunofluorescence Localization for Assessment of Therapeutic and Diagnostic Antibody Biodistribution in Cancer Research

Published on: September 16, 2019

9.4K

Area of Science:

  • Immunology
  • Pharmacology
  • Transplantation medicine

Background:

  • Imlifidase is a novel enzyme developed for treating IgG-mediated conditions.
  • It targets immunoglobulin G (IgG) degradation.
  • Hansa Biopharma AB is developing imlifidase for transplant rejection and autoimmune diseases.

Purpose of the Study:

  • To summarize the developmental milestones of imlifidase.
  • To highlight the first global approval of intravenous imlifidase.
  • To detail its use in desensitization treatment for kidney transplant patients.

Main Methods:

  • Review of imlifidase development history.
  • Analysis of clinical evaluation data.
  • Summary of regulatory approval processes.

Main Results:

  • First global approval of intravenous imlifidase in the EU in August 2020.
  • Approval for desensitization treatment of highly sensitized adult kidney transplant patients with positive crossmatch.
  • Ongoing clinical evaluations for kidney transplant rejection prevention and autoimmune diseases.

Conclusions:

  • Imlifidase represents a significant advancement in transplant medicine.
  • The EU approval marks a critical milestone for highly sensitized patients.
  • Further clinical development is underway for broader applications.