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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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, controlled...
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF01:24

Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF

Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab (Humira),...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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...
Microorganisms in Medicine and Therapeutics01:29

Microorganisms in Medicine and Therapeutics

Microorganisms play a fundamental role in vaccine development, gene therapy, and therapeutic production. Their biological properties are harnessed to advance medicine and public health. Beyond immunization, microorganisms contribute to gut health, antibiotic synthesis, and genetic disease treatment.Live Attenuated and Inactivated VaccinesLive attenuated vaccines, such as the measles, mumps, and rubella (MMR) vaccine, utilize weakened forms of pathogens to closely resemble natural infections.
Targeted Cancer Therapies02:57

Targeted Cancer Therapies

The targeted cancer therapies, also known as “molecular targeted therapies,” take advantage of the molecular and genetic differences between the cancer cells and the normal cells. It needs a thorough understanding of the cancer cells to develop drugs that can target specific molecular aspects that drive the growth, progression, and spread of cancer cells without affecting the growth and survival of other normal cells in the body.
There are several types of targeted therapies against specific...

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Related Experiment Video

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Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization
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Safety of biologic therapy.

Wojciech Blonski1, Gary R Lichtenstein

  • 1Department of Gastroenterology and Hepatology, Wroclaw Medical University, Wroclaw, Poland.

Inflammatory Bowel Diseases
|February 17, 2007
PubMed
Summary

Infliximab, a biologic agent, effectively treats moderate to severe inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. It induces remission, promotes mucosal healing, and reduces corticosteroid dependence in IBD patients.

Area of Science:

  • Gastroenterology
  • Immunology
  • Pharmacology

Background:

  • Biologic agents are increasingly used for inflammatory bowel disease (IBD).
  • Infliximab, a humanized monoclonal anti-TNF-alpha antibody, has shown promise in treating IBD.
  • Limited data existed for other biologic agents compared to infliximab.

Purpose of the Study:

  • To review the efficacy and safety of infliximab in patients with inflammatory bowel disease (IBD).
  • To highlight infliximab's role in inducing and maintaining remission in Crohn's disease and ulcerative colitis.
  • To emphasize the robust safety data available for infliximab.

Main Methods:

  • Review of randomized controlled trials and open-label studies assessing biologic agents for IBD.
  • Analysis of data from ACT 1 and ACT 2 trials for infliximab in ulcerative colitis.

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  • Evaluation of postmarketing surveillance data for infliximab safety.
  • Main Results:

    • Infliximab demonstrated high efficacy in inducing and maintaining remission in moderate to severe ulcerative colitis.
    • Mucosal healing and corticosteroid-sparing effects were observed in ulcerative colitis patients treated with infliximab.
    • Infliximab is approved by the FDA for active mild to moderate and fistulizing Crohn's disease refractory to conventional therapy.

    Conclusions:

    • Infliximab is a valuable biologic treatment option for patients with moderate to severe inflammatory bowel disease (IBD).
    • The extensive clinical trial data and postmarketing experience provide robust safety information for infliximab.
    • Infliximab offers significant benefits, including remission induction, mucosal healing, and reduced corticosteroid use in IBD patients.