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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
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...
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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.
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

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...
Production of Pharmaceuticals01:30

Production of Pharmaceuticals

Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under sterile, tightly...

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ValiRx plc.

Mark Eccleston1, George Morris1

  • 1ValiRx plc, 24 Greville Street, London, EC1N 8SS, UK. mark.eccleston@valirx.com.

Personalized Medicine
|May 23, 2018
PubMed
Summary
This summary is machine-generated.

ValiRx plc is developing innovative cancer diagnostics and therapeutics. Their technologies, Hypergenomics™ and GeneICE™, target cancer epigenomics for early detection and gene silencing treatments.

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Area of Science:

  • Oncology
  • Genomics
  • Epigenetics

Background:

  • Over 95% of cellular DNA is packaged into chromatin, limiting access for cellular machinery.
  • Cancer diagnosis, treatment, and prognosis require advanced molecular insights.

Purpose of the Study:

  • To present ValiRx plc's integrated approach to cancer care.
  • To introduce proprietary technologies for cancer epigenomic analysis and gene-silencing therapeutics.

Main Methods:

  • Development of noninvasive screening tests using Hypergenomics™ and Nucleosomics™ technologies for cancer detection.
  • Creation of gene-silencing therapeutics via the GeneICE™ platform for targeted gene deactivation.
  • Exploitation of epigenomic structures for cancer profiling.

Main Results:

  • Patented technologies enable rapid, high-throughput, and low-cost cancer screening.
  • GeneICE™ platform facilitates targeted gene deactivation by repackaging DNA.
  • Synergistic platforms aim to correlate genomic profiles with specific cancer types.

Conclusions:

  • ValiRx's technologies offer a novel approach to early cancer detection and personalized treatment.
  • The integrated strategy addresses diagnosis, treatment, and prognosis of cancer.
  • Correlating genomic hypersensitive sites with cancer types can optimize treatment regimes.